From Reuters Health Information
By Frederik Joelving
NEW YORK (Reuters Health) Jul 21 - Pap smears in women under 21 do more harm than good, new guidelines from the American College of Obstetricians and Gynecologists (ACOG) say.
In most cases such tests reveal only human papillomavirus (HPV) infections, which rarely lead to cervical cancer in women under 21, said Dr. Mark Einstein of the Albert Einstein College of Medicine (no relation) in the Bronx, New York.
"They have a better chance of winning the lottery than getting cancer at that age," said Dr. Einstein, who is an ACOG fellow but did not work on the guidelines.
"Over-screening adolescents is really detrimental to young women," he told Reuters Health. "We increase their anxiety, we increase their time away from school and work."
The new guidelines, published online today in Obstetrics & Gynecology, reinforce earlier recommendations issued this past November. But they add that adolescents with compromised immunity should not wait until 21 to be screened.
Although this group makes up less than one percent of adolescents, said Dr. Einstein, they are much more vulnerable to cancer from HPV.
Prior recommendations called for annual cervical cancer screening to start three years after a woman first becomes sexually active, or by age 21.
In the past 30 years, cervical cancer rates in the United States have fallen by more than half, due in large part to widespread use of cervical cancer screening.
In its November 2009 guidelines, ACOG recommended that women between 21 and 30 years undergo cervical cancer screening once every two years instead of annually. Those 30 and older can be screened once every three years. The new recommendations do not refer to women between 21 and 30.
SOURCE: http://link.reuters.com/juv78m
Obstet Gynecol 2010.
Thursday, July 22, 2010
ACOG Issues Less Restrictive Guidelines for Vaginal Birth After Cesarean Delivery
From Medscape Medical News
Laurie Barclay, MD
July 22, 2010 — Trial of labor after previous cesarean delivery (TOLAC) is safe and appropriate for most women with previous cesarean delivery, including some women with 2 previous cesarean deliveries, according to less restrictive guidelines issued by the American College of Obstetricians and Gynecologists (ACOG). The revised recommendations for planned vaginal birth after cesarean (VBAC) are reported in a practice bulletin published in the August issue of Obstetrics & Gynecology.
"The current cesarean rate is undeniably high and absolutely concerns us as ob-gyns," said ACOG president Richard N. Waldman, MD, in a news release. "These VBAC guidelines emphasize the need for thorough counseling of benefits and risks, shared patient-doctor decision making, and the importance of patient autonomy. Moving forward, we need to work collaboratively with our patients and our colleagues, hospitals, and insurers to swing the pendulum back to fewer cesareans and a more reasonable VBAC rate."
ACOG defines the term trial of labor as a trial of labor in women who have had a previous cesarean delivery, regardless of outcome. Also, the term vaginal birth after cesarean delivery is used to denote a vaginal delivery after a trial of labor.
Benefits of VBAC
ACOG's guidelines indicate the potential advantages of VBAC for the individual patient. These benefits include maternal preference and reduced maternal morbidity and a lower risk for complications in future pregnancies. At the population level, VBAC is also associated with a lower overall rate of cesarean deliveries.
"Approximately 60–80% of appropriate candidates who attempt VBAC will be successful," said statement coauthor Jeffrey L. Ecker, MD, from Massachusetts General Hospital in Boston. "A VBAC avoids major abdominal surgery, lowers a woman's risk of hemorrhage and infection, and shortens postpartum recovery. It may also help women avoid the possible future risks of having multiple cesareans such as hysterectomy, bowel and bladder injury, transfusion, infection, and abnormal placenta conditions (placenta previa and placenta accreta)."
Because failed TOLAC is associated with increased maternal and perinatal morbidity vs elective repeat cesarean delivery, it is important to evaluate individual risks and the likelihood of VBAC when deciding whether TOLAC is a feasible option. A successful VBAC has fewer complications than an elective repeat cesarean delivery, and the new guidelines attempt to point out the risks and benefits of TOLAC in different clinical settings and to offer practical recommendations for treatment and counseling of women who will undergo VBAC.
"The College guidelines now clearly say that women with two previous low-transverse cesarean incisions, women carrying twins, and women with an unknown type of uterine scar are considered appropriate candidates for a TOLAC," Dr. Ecker said. "In making plans for delivery, physicians and patients should consider a woman's chance of a successful VBAC as well as the risk of complications from a trial of labor, all viewed in the context of her future reproductive plans."
ACOG's Revised VBAC Guidelines
The practice bulletin makes the following specific recommendations based on good, consistent scientific evidence (level A):
* TOLAC may be appropriate for most women with 1 previous cesarean delivery via a low transverse incision. These women should be counseled about VBAC and offered TOLAC as a delivery option.
* As part of TOLAC, epidural analgesia may be used for labor.
* For women who have undergone previous cesarean delivery or major uterine surgery, misoprostol should not be used for third-trimester cervical ripening or labor induction.
Also included in the statement are the following recommendations based on limited or inconsistent scientific evidence (level B):
* TOLAC may be considered in women with 2 previous low transverse cesarean deliveries.
* TOLAC may be considered in women with 1 previous cesarean delivery via a low transverse incision who are otherwise appropriate candidates for twin vaginal delivery.
* In women with previous cesarean delivery via low transverse uterine incision who are at low risk for adverse maternal or neonatal outcomes from external cephalic version and TOLAC, external cephalic version for breech presentation is not contraindicated.
* Planned TOLAC is generally not recommended in women at high risk for complications, such as those with classic or T-incision, prior uterine rupture, or extensive transfundal uterine surgery. Also, planned TOLAC is not recommended in women in whom vaginal delivery is contraindicated, such as those with placenta previa.
* In women undergoing TOLAC, it is permissible to induce labor, when appropriate, based on maternal or fetal indications.
* For women with previous cesarean delivery with an unknown uterine scar type, TOLAC is not contraindicated unless there is a high clinical suspicion for a previous classic uterine incision.
Finally, the statement also provides the following recommendations that are based mainly on consensus and expert opinion (level C):
* Women undergoing TOLAC should do so at facilities able to perform emergency deliveries and with staff immediately available to provide emergency care because of unpredictable risks associated with TOLAC.
* When these resources are not available, women should be clearly advised regarding greater risks for TOLAC and management alternatives, and counseling and the management plan should be documented in the medical record.
"It is absolutely critical that a woman and her physician discuss VBAC early in the prenatal care period so that logistical plans can be made well in advance," said coauthor William A. Grobman, MD, from Northwestern University in Chicago, Illinois.
A performance measure proposed by the statement is the percentage of women who are candidates for TOLAC with whom discussion of the risk and benefits of TOLAC vs elective repeat cesarean delivery has been recorded in the medical chart.
"Given the onerous medical liability climate for ob-gyns, interpretation of The College's earlier guidelines led many hospitals to refuse allowing VBACs altogether," Dr. Grobman concluded. "Our primary goal is to promote the safest environment for labor and delivery, not to restrict women's access to VBAC."
Lamaze International's Statement on ACOG Guidelines
In response to the ACOG revised VBAC guidelines, Lamaze International has issued a statement commending the guidelines as a "step in the right direction" in reducing the number of cesarean deliveries. However, Lamaze International is "troubled by elements of the guidelines which continue to support practices that may increase risks and cause undue harm to mother and baby."
The organization questions ACOG's emphasis on uterine rupture, which is rare in VBAC. Lamaze International also points out that ACOG's use of certain language related to "immediately available" emergency resources may cause women to continue to have unfair access to VBAC.
Although Lamaze International takes issue with some of the elements of the revised guidelines, the organization is pleased with ACOG's emphasis on the benefits of a planned VBAC.
Practice Bulletin No. 115, "Vaginal Birth after Previous Cesarean Delivery," is published in the August 2010 issue of Obstetrics & Gynecology.
Obstet Gynecol. 2010;116:450-463.
Laurie Barclay, MD
July 22, 2010 — Trial of labor after previous cesarean delivery (TOLAC) is safe and appropriate for most women with previous cesarean delivery, including some women with 2 previous cesarean deliveries, according to less restrictive guidelines issued by the American College of Obstetricians and Gynecologists (ACOG). The revised recommendations for planned vaginal birth after cesarean (VBAC) are reported in a practice bulletin published in the August issue of Obstetrics & Gynecology.
"The current cesarean rate is undeniably high and absolutely concerns us as ob-gyns," said ACOG president Richard N. Waldman, MD, in a news release. "These VBAC guidelines emphasize the need for thorough counseling of benefits and risks, shared patient-doctor decision making, and the importance of patient autonomy. Moving forward, we need to work collaboratively with our patients and our colleagues, hospitals, and insurers to swing the pendulum back to fewer cesareans and a more reasonable VBAC rate."
ACOG defines the term trial of labor as a trial of labor in women who have had a previous cesarean delivery, regardless of outcome. Also, the term vaginal birth after cesarean delivery is used to denote a vaginal delivery after a trial of labor.
Benefits of VBAC
ACOG's guidelines indicate the potential advantages of VBAC for the individual patient. These benefits include maternal preference and reduced maternal morbidity and a lower risk for complications in future pregnancies. At the population level, VBAC is also associated with a lower overall rate of cesarean deliveries.
"Approximately 60–80% of appropriate candidates who attempt VBAC will be successful," said statement coauthor Jeffrey L. Ecker, MD, from Massachusetts General Hospital in Boston. "A VBAC avoids major abdominal surgery, lowers a woman's risk of hemorrhage and infection, and shortens postpartum recovery. It may also help women avoid the possible future risks of having multiple cesareans such as hysterectomy, bowel and bladder injury, transfusion, infection, and abnormal placenta conditions (placenta previa and placenta accreta)."
Because failed TOLAC is associated with increased maternal and perinatal morbidity vs elective repeat cesarean delivery, it is important to evaluate individual risks and the likelihood of VBAC when deciding whether TOLAC is a feasible option. A successful VBAC has fewer complications than an elective repeat cesarean delivery, and the new guidelines attempt to point out the risks and benefits of TOLAC in different clinical settings and to offer practical recommendations for treatment and counseling of women who will undergo VBAC.
"The College guidelines now clearly say that women with two previous low-transverse cesarean incisions, women carrying twins, and women with an unknown type of uterine scar are considered appropriate candidates for a TOLAC," Dr. Ecker said. "In making plans for delivery, physicians and patients should consider a woman's chance of a successful VBAC as well as the risk of complications from a trial of labor, all viewed in the context of her future reproductive plans."
ACOG's Revised VBAC Guidelines
The practice bulletin makes the following specific recommendations based on good, consistent scientific evidence (level A):
* TOLAC may be appropriate for most women with 1 previous cesarean delivery via a low transverse incision. These women should be counseled about VBAC and offered TOLAC as a delivery option.
* As part of TOLAC, epidural analgesia may be used for labor.
* For women who have undergone previous cesarean delivery or major uterine surgery, misoprostol should not be used for third-trimester cervical ripening or labor induction.
Also included in the statement are the following recommendations based on limited or inconsistent scientific evidence (level B):
* TOLAC may be considered in women with 2 previous low transverse cesarean deliveries.
* TOLAC may be considered in women with 1 previous cesarean delivery via a low transverse incision who are otherwise appropriate candidates for twin vaginal delivery.
* In women with previous cesarean delivery via low transverse uterine incision who are at low risk for adverse maternal or neonatal outcomes from external cephalic version and TOLAC, external cephalic version for breech presentation is not contraindicated.
* Planned TOLAC is generally not recommended in women at high risk for complications, such as those with classic or T-incision, prior uterine rupture, or extensive transfundal uterine surgery. Also, planned TOLAC is not recommended in women in whom vaginal delivery is contraindicated, such as those with placenta previa.
* In women undergoing TOLAC, it is permissible to induce labor, when appropriate, based on maternal or fetal indications.
* For women with previous cesarean delivery with an unknown uterine scar type, TOLAC is not contraindicated unless there is a high clinical suspicion for a previous classic uterine incision.
Finally, the statement also provides the following recommendations that are based mainly on consensus and expert opinion (level C):
* Women undergoing TOLAC should do so at facilities able to perform emergency deliveries and with staff immediately available to provide emergency care because of unpredictable risks associated with TOLAC.
* When these resources are not available, women should be clearly advised regarding greater risks for TOLAC and management alternatives, and counseling and the management plan should be documented in the medical record.
"It is absolutely critical that a woman and her physician discuss VBAC early in the prenatal care period so that logistical plans can be made well in advance," said coauthor William A. Grobman, MD, from Northwestern University in Chicago, Illinois.
A performance measure proposed by the statement is the percentage of women who are candidates for TOLAC with whom discussion of the risk and benefits of TOLAC vs elective repeat cesarean delivery has been recorded in the medical chart.
"Given the onerous medical liability climate for ob-gyns, interpretation of The College's earlier guidelines led many hospitals to refuse allowing VBACs altogether," Dr. Grobman concluded. "Our primary goal is to promote the safest environment for labor and delivery, not to restrict women's access to VBAC."
Lamaze International's Statement on ACOG Guidelines
In response to the ACOG revised VBAC guidelines, Lamaze International has issued a statement commending the guidelines as a "step in the right direction" in reducing the number of cesarean deliveries. However, Lamaze International is "troubled by elements of the guidelines which continue to support practices that may increase risks and cause undue harm to mother and baby."
The organization questions ACOG's emphasis on uterine rupture, which is rare in VBAC. Lamaze International also points out that ACOG's use of certain language related to "immediately available" emergency resources may cause women to continue to have unfair access to VBAC.
Although Lamaze International takes issue with some of the elements of the revised guidelines, the organization is pleased with ACOG's emphasis on the benefits of a planned VBAC.
Practice Bulletin No. 115, "Vaginal Birth after Previous Cesarean Delivery," is published in the August 2010 issue of Obstetrics & Gynecology.
Obstet Gynecol. 2010;116:450-463.
WHO Guidelines Call for Prompt HIV Testing and Treatment of Newborns
From Medscape Medical News
Norra MacReady
July 22, 2010 (Vienna, Austria) — Infants born to mothers who are HIV-positive should have their HIV status determined at birth or soon after, with a diagnosis of HIV infection confirmed within 4 to 6 weeks of age, so that treatment can be initiated as early as possible, according to new guidelines issued by the World Health Organization (WHO). The guidelines are available at on the WHO Web site.
As many as one third of HIV-infected infants die before their first birthday, WHO officials said here at AIDS 2010: XVIII International AIDS Conference, in announcing the new treatment guidelines. By age 2 years, mortality is roughly 50%. Prompt diagnosis and treatment improve survival dramatically. "Compelling data show unequivocally that early initiation of treatment reduces mortality 5-fold," Shaffiq Essajee, MD, medical officer, pediatrics and family care, in the HIV Department of WHO, told Medscape Medical News.
WHO is trying to eliminate mother-to-child transmission of HIV completely, perhaps as early as 2015.
"We are expanding significantly the recommendation to identify potentially infected children," Dr. Essajee said. "Previously, we advocated for testing sick children in hospital care settings and children known to be exposed through mother-to-child transmission. Now we're going one step further, saying that every child should have their exposure status ascertained as soon as possible. That's the only way we can then link that child to the appropriate care, testing, and treatment services that they need to prevent the morbidity and mortality that occurs in [HIV-positive] children."
Officials in regions with a high burden of HIV disease, defined as prevalence of more than 1% in the general population, are urged to adopt a strategy of ascertaining a neonate's HIV exposure status and beginning treatment as soon as possible. The very high mortality rates among infected children during their first 2 years of life "makes infants and children the most vulnerable of all people living with HIV," Dr. Essajee said.
WHO has done a good job of closing the treatment gap between children and adults, Dr. Essajee said. By the end of 2008, 276,000 children were receiving treatment; by the following year, that number was up to 355,000. However, until now, most of those efforts have been directed at older children, with distressing consequences. "By the time a child reaches 5 years of age, only 1 in 5 has survived," Dr. Essajee added.
"In the recommendations launched today, we're saying any child under the age of 2 should be treated, because mortality in this age group is so high," said Chewe Luo, MD, PhD, senior advisor for HIV-AIDS in the program division of the United Nations Children's Fund.
Many children are still going undiagnosed, Dr. Luo told Medscape Medical News. "What's critical about these guidelines is that they call for screening these babies as early as 6 weeks, and once you've made the diagnosis, you refer them for treatment."
Infants in impoverished, high-risk regions can have their blood samples dried on filter paper and sent to laboratories for analysis. "This works very well in field conditions," Dr. Luo said. Treatment can begin as soon as the diagnosis is confirmed.
Treatment for HIV-infected children basically is the same as it is for adults — lifelong triple therapy using several different classes of drugs — Dr. Essajee said. Management becomes more complicated if the mother has been on the antiretroviral drug nevirapine during pregnancy, as children exposed to nevirapine in utero may develop resistance to it, so pediatric regimens ideally should include protease inhibitors, as well as triple therapy.
However, Dr. Essajee acknowledges that protease inhibitors can be pricey. "So we tell clinicians that if you don't have access to these expensive and hard-to-get protease inhibitors, treat anyway with the nevirapine you have available, because it's not inevitable that every child will develop a resistance mutation, and even if they do, it's not inevitable that the clinical impact of that resistance mutation will be treatment failure for the child."
"So even if you don't have access to protease inhibitors, don't fall short of initiating aggressive treatment simply because you can't abide by the letter of the law as the WHO has defined it," Dr. Luo urged.
Neither Dr. Essajee nor Dr. Luo has disclosed any relevant financial relationships.
AIDS 2010: XVIII International AIDS Conference. Presented July 20, 2010.
Norra MacReady
July 22, 2010 (Vienna, Austria) — Infants born to mothers who are HIV-positive should have their HIV status determined at birth or soon after, with a diagnosis of HIV infection confirmed within 4 to 6 weeks of age, so that treatment can be initiated as early as possible, according to new guidelines issued by the World Health Organization (WHO). The guidelines are available at on the WHO Web site.
As many as one third of HIV-infected infants die before their first birthday, WHO officials said here at AIDS 2010: XVIII International AIDS Conference, in announcing the new treatment guidelines. By age 2 years, mortality is roughly 50%. Prompt diagnosis and treatment improve survival dramatically. "Compelling data show unequivocally that early initiation of treatment reduces mortality 5-fold," Shaffiq Essajee, MD, medical officer, pediatrics and family care, in the HIV Department of WHO, told Medscape Medical News.
WHO is trying to eliminate mother-to-child transmission of HIV completely, perhaps as early as 2015.
"We are expanding significantly the recommendation to identify potentially infected children," Dr. Essajee said. "Previously, we advocated for testing sick children in hospital care settings and children known to be exposed through mother-to-child transmission. Now we're going one step further, saying that every child should have their exposure status ascertained as soon as possible. That's the only way we can then link that child to the appropriate care, testing, and treatment services that they need to prevent the morbidity and mortality that occurs in [HIV-positive] children."
Officials in regions with a high burden of HIV disease, defined as prevalence of more than 1% in the general population, are urged to adopt a strategy of ascertaining a neonate's HIV exposure status and beginning treatment as soon as possible. The very high mortality rates among infected children during their first 2 years of life "makes infants and children the most vulnerable of all people living with HIV," Dr. Essajee said.
WHO has done a good job of closing the treatment gap between children and adults, Dr. Essajee said. By the end of 2008, 276,000 children were receiving treatment; by the following year, that number was up to 355,000. However, until now, most of those efforts have been directed at older children, with distressing consequences. "By the time a child reaches 5 years of age, only 1 in 5 has survived," Dr. Essajee added.
"In the recommendations launched today, we're saying any child under the age of 2 should be treated, because mortality in this age group is so high," said Chewe Luo, MD, PhD, senior advisor for HIV-AIDS in the program division of the United Nations Children's Fund.
Many children are still going undiagnosed, Dr. Luo told Medscape Medical News. "What's critical about these guidelines is that they call for screening these babies as early as 6 weeks, and once you've made the diagnosis, you refer them for treatment."
Infants in impoverished, high-risk regions can have their blood samples dried on filter paper and sent to laboratories for analysis. "This works very well in field conditions," Dr. Luo said. Treatment can begin as soon as the diagnosis is confirmed.
Treatment for HIV-infected children basically is the same as it is for adults — lifelong triple therapy using several different classes of drugs — Dr. Essajee said. Management becomes more complicated if the mother has been on the antiretroviral drug nevirapine during pregnancy, as children exposed to nevirapine in utero may develop resistance to it, so pediatric regimens ideally should include protease inhibitors, as well as triple therapy.
However, Dr. Essajee acknowledges that protease inhibitors can be pricey. "So we tell clinicians that if you don't have access to these expensive and hard-to-get protease inhibitors, treat anyway with the nevirapine you have available, because it's not inevitable that every child will develop a resistance mutation, and even if they do, it's not inevitable that the clinical impact of that resistance mutation will be treatment failure for the child."
"So even if you don't have access to protease inhibitors, don't fall short of initiating aggressive treatment simply because you can't abide by the letter of the law as the WHO has defined it," Dr. Luo urged.
Neither Dr. Essajee nor Dr. Luo has disclosed any relevant financial relationships.
AIDS 2010: XVIII International AIDS Conference. Presented July 20, 2010.
Monday, July 12, 2010
Parenting a VLBW Child May Have Both Positive and Negative Outcomes
From MedscapeCME Clinical Briefs
News Author: Laurie Barclay, MD
CME Author: Désirée Lie, MD, MSEd
June 29, 2010 — Parenting a very low-birth-weight (VLBW) child has both positive and negative outcomes, according to the results of a prospective cohort follow-up study reported in the June issue of Archives of Pediatric & Adolescent Medicine.
"Long-term outcome studies indicate persistent functional disabilities in a significant proportion of...VLBW children, leading to research interest in parental stress and adaptation to preterm birth and their effects on the family," write Lynn T. Singer, PhD, from Case Western Reserve University in Cleveland, Ohio, and colleagues. "Understanding the experiences of parents of VLBW children is important for medical decision making and the design of intervention programs to improve child outcomes. Children's behavioral and cognitive outcomes are known to be related to maternal psychological status, family stress, financial burden, and maternal coping strategies, all of which have been shown to be affected by VLBW birth."
The goal of the study was to evaluate longitudinal outcomes and factors affecting parental stress and coping in mothers of 113 high-risk VLBW children with bronchopulmonary dysplasia, 80 low-risk VLBW children without bronchopulmonary dysplasia, and 122 term children. These 3 groups had similar demographic characteristics and were followed up from birth to age 14 years.
From November 8, 1989, to February 22, 1992, participants were recruited from level III neonatal intensive care and term nurseries in a large Midwestern region, and they were subsequently followed up at an academic medical center. The main study endpoints were child IQ and self-reported measures of parenting stress, family impact, maternal coping, education, and social support.
Compared with term mothers, mothers of VLBW children had fewer additional years of education (P = .04). Compared with term mothers, mothers of high-risk VLBW children also reported more personal stress (P = .006) and family stress (P = .009) under conditions of low social support, as well as greater child-related stress. Despite greater perceived stress, however, mothers of high-risk VLBW children also reported the highest levels of parenting satisfaction at 14 years. With time, they became less likely to use coping mechanisms of denial (P = .02) and mental disengagement (P = .03).
Except for educational level, mothers of low-risk VLBW infants did not differ from mothers of term children. At 14 years, mothers of low-risk VLBW infants reported the lowest stress of all 3 groups.
"Parenting a VLBW child had both positive and negative outcomes, dependent on child medical risk, child IQ, social support, and maternal coping mechanisms, suggesting that mothers experience posttraumatic growth and resilience after significant distress post partum," the study authors write.
Limitations of this study include reliance on mothers' self-report of stress and coping and long intervals between follow-up visits.
"Although mothers of VLBW children demonstrate significant resilience through their children's early adolescence on the whole, mothers with low social support, with avoidant coping styles, and whose children have significant disabilities should continue to be monitored by health care and education professionals," the study authors conclude. "It will be important to educate health care providers about the role of coping mechanisms and social support in modifying stress. More research is needed into the best ways to support parents of VLBW children and to help them develop adaptive coping mechanisms."
The Maternal and Child Health Program, Health Resources and Services Administration, Department of Health and Human Services, Rockville, Maryland, supported this study. The study authors have disclosed no relevant financial relationships.
Arch Pediatr Adolesc Med. 2010;164:518-524. Abstract
News Author: Laurie Barclay, MD
CME Author: Désirée Lie, MD, MSEd
June 29, 2010 — Parenting a very low-birth-weight (VLBW) child has both positive and negative outcomes, according to the results of a prospective cohort follow-up study reported in the June issue of Archives of Pediatric & Adolescent Medicine.
"Long-term outcome studies indicate persistent functional disabilities in a significant proportion of...VLBW children, leading to research interest in parental stress and adaptation to preterm birth and their effects on the family," write Lynn T. Singer, PhD, from Case Western Reserve University in Cleveland, Ohio, and colleagues. "Understanding the experiences of parents of VLBW children is important for medical decision making and the design of intervention programs to improve child outcomes. Children's behavioral and cognitive outcomes are known to be related to maternal psychological status, family stress, financial burden, and maternal coping strategies, all of which have been shown to be affected by VLBW birth."
The goal of the study was to evaluate longitudinal outcomes and factors affecting parental stress and coping in mothers of 113 high-risk VLBW children with bronchopulmonary dysplasia, 80 low-risk VLBW children without bronchopulmonary dysplasia, and 122 term children. These 3 groups had similar demographic characteristics and were followed up from birth to age 14 years.
From November 8, 1989, to February 22, 1992, participants were recruited from level III neonatal intensive care and term nurseries in a large Midwestern region, and they were subsequently followed up at an academic medical center. The main study endpoints were child IQ and self-reported measures of parenting stress, family impact, maternal coping, education, and social support.
Compared with term mothers, mothers of VLBW children had fewer additional years of education (P = .04). Compared with term mothers, mothers of high-risk VLBW children also reported more personal stress (P = .006) and family stress (P = .009) under conditions of low social support, as well as greater child-related stress. Despite greater perceived stress, however, mothers of high-risk VLBW children also reported the highest levels of parenting satisfaction at 14 years. With time, they became less likely to use coping mechanisms of denial (P = .02) and mental disengagement (P = .03).
Except for educational level, mothers of low-risk VLBW infants did not differ from mothers of term children. At 14 years, mothers of low-risk VLBW infants reported the lowest stress of all 3 groups.
"Parenting a VLBW child had both positive and negative outcomes, dependent on child medical risk, child IQ, social support, and maternal coping mechanisms, suggesting that mothers experience posttraumatic growth and resilience after significant distress post partum," the study authors write.
Limitations of this study include reliance on mothers' self-report of stress and coping and long intervals between follow-up visits.
"Although mothers of VLBW children demonstrate significant resilience through their children's early adolescence on the whole, mothers with low social support, with avoidant coping styles, and whose children have significant disabilities should continue to be monitored by health care and education professionals," the study authors conclude. "It will be important to educate health care providers about the role of coping mechanisms and social support in modifying stress. More research is needed into the best ways to support parents of VLBW children and to help them develop adaptive coping mechanisms."
The Maternal and Child Health Program, Health Resources and Services Administration, Department of Health and Human Services, Rockville, Maryland, supported this study. The study authors have disclosed no relevant financial relationships.
Arch Pediatr Adolesc Med. 2010;164:518-524. Abstract
Sunday, July 11, 2010
Management of Osteoporosis in Postmenopausal Women: 2010 Position Statement
Recommendations
Management strategies for osteoporosis in postmenopausal women require assessment of risk factors for BMD-defined osteoporosis and osteoporotic fracture, followed by institution of measures that focus on reducing risk factors through lifestyle changes and, if indicated, pharmacologic therapy.
* All postmenopausal women should be encouraged to employ lifestyle practices that reduce the risk of bone loss and osteoporotic fractures: maintaining a healthy weight, eating a balanced diet, obtaining adequate calcium and vitamin D, participating in appropriate exercise, avoiding excessive alcohol consumption, not smoking, and utilizing measures to prevent falls. Periodic reviews of calcium and vitamin D intake and lifestyle behaviors are useful.
After menopause, a woman's risk of falls should be assessed annually and at any time her physical or mental status changes.
* The physical examination should include an annual measurement of height and weight, along with an assessment for chronic back pain, kyphosis, and clinical risk factors.
* BMD testing is indicated for:
o All postmenopausal women with medical causes of bone loss
o All women age 65 and over
* BMD testing should be considered for postmenopausal women age 50 and older who have one or more of the following risk factors:
o Previous fracture (other than skull, facial bone, ankle, finger, and toe) after menopause
o Thinness (body weight < 127 lbs [57.7 kg] or BMI < 21 kg/m2)
o History of hip fracture in a parent
o Current smoking
o Rheumatoid arthritis
o Excessive alcohol intake
* When BMD testing is indicated, DXA is the preferred technique. The total hip, femoral neck, and posterior-anterior lumbar spine should be measured, using the lowest of the three BMD scores.
* The routine use of biochemical markers of bone turnover in clinical practice is not generally recommended.
* Vertebral fracture must be confirmed by lateral spine radiographs or VFA visualization of fracture at the time of BMD testing. Vertebral fracture is confirmed by height loss >20% of the anterior, mid, or posterior dimension of a vertebra on imaging.
* An adequate intake of both calcium and vitamin D is important for bone health and is recognized as an important component of any osteoporosis prescription-drug regimen. NAMS follows the NOF recommendations of calcium intake of 1,200 mg/day for adults age 50 and older, and vitamin D3 of 800 to 1,000 IU/day.
* NAMS recommends osteoporosis drug therapy in the following populations:
o All postmenopausal women who have had an osteoporotic vertebral or hip fracture
o All postmenopausal women who have BMD values consistent with osteoporosis (ie, T-scores ≤−2.5) at the lumbar spine, femoral neck, or total hip region
o All postmenopausal women who have T-scores from −1.0 to −2.5 and a 10-year risk, based on the FRAX calculator, of major osteoporotic fracture (spine, hip, shoulder, and wrist) of at least 20% or of hip fracture of at least 3%
* It is important to encourage adherence to the treatment plan and to identify barriers to nonadherence. Providing clear information to women regarding their risk for fracture and the purpose of osteoporosis therapy may be the optimal way to improve adherence.
* During therapy, it is appropriate to reevaluate the treatment goals and the choice of medication on an ongoing basis through periodic medical examination and a follow-up BMD testing. Measurement of BMD has limited use in predicting the effectiveness of antiresorptive therapies for reducing fracture risk. Also, fracture risk reductions from therapy occur much more rapidly than BMD changes. An appropriate interval for repeat BMD testing is after 1 to 2 years of treatment. There appears to be little value in repeat testing if a woman is stable (within the precision error of the original instrument).
* For untreated postmenopausal women, repeat DXA testing is not useful until 2 to 5 years have passed.
* Bisphosphonates are the first-line drugs for treating postmenopausal women with osteoporosis. They have reduced the risk of vertebral fractures by 40% to 70% and reduced the incidence of nonvertebral fracture, including hip fracture, by about half this amount.
* The SERM raloxifene is most often considered for postmenopausal women with low bone mass or younger postmenopausal women with osteoporosis. It prevents bone loss and reduces the risk of vertebral fractures, but its effectiveness in reducing other fractures is uncertain. Extraskeletal risks and benefits are important when considering raloxifene therapy.
* Teriparatide (PTH 1–34) is best offered to postmenopausal women with osteoporosis who are at high risk for fracture. Daily subcutaneous injections have been shown to stimulate bone formation and improve bone density. Therapy is indicated for no more than 24 months.
* The primary indication for systemic ET/EPT is to treat moderate to severe menopause symptoms (eg, vasomotor symptoms). When symptoms are controlled or cease, continued hormone therapy can still be considered for bone effects, weighing its benefits and risks against those of alternative therapies.
* ET/EPT may be a treatment option for a few years of early postmenopause.
* Calcitonin is not a first-line drug for postmenopausal osteoporosis treatment, as its fracture efficacy is not strong and its BMD effects are less than those of other agents. However, it is an option for women with osteoporosis who are more than 5 years beyond menopause. Calcitonin therapy may reduce vertebral fracture risk in women with osteoporosis, although the evidence documenting fracture protection is not strong. It is not recommended for treating bone pain, except bone pain from acute vertebral compression fractures.
* Data are inadequate to make definitive recommendations regarding combination or serial anabolic and antiresorptive drug therapies.
* The treatment of osteoporosis needs to be long term in most women.
* If drug-related adverse effects occur, appropriate management strategies should be instituted. If adverse effects persist, switching to another agent may be required.
* Decisions to discontinue or suspend therapy are based on the woman's risk of fracture and her response to treatment. Given the uncertainties of long-term drug safety, careful monitoring is required. Fracture risk after discontinuing therapy has not been adequately evaluated.
Management strategies for osteoporosis in postmenopausal women require assessment of risk factors for BMD-defined osteoporosis and osteoporotic fracture, followed by institution of measures that focus on reducing risk factors through lifestyle changes and, if indicated, pharmacologic therapy.
* All postmenopausal women should be encouraged to employ lifestyle practices that reduce the risk of bone loss and osteoporotic fractures: maintaining a healthy weight, eating a balanced diet, obtaining adequate calcium and vitamin D, participating in appropriate exercise, avoiding excessive alcohol consumption, not smoking, and utilizing measures to prevent falls. Periodic reviews of calcium and vitamin D intake and lifestyle behaviors are useful.
After menopause, a woman's risk of falls should be assessed annually and at any time her physical or mental status changes.
* The physical examination should include an annual measurement of height and weight, along with an assessment for chronic back pain, kyphosis, and clinical risk factors.
* BMD testing is indicated for:
o All postmenopausal women with medical causes of bone loss
o All women age 65 and over
* BMD testing should be considered for postmenopausal women age 50 and older who have one or more of the following risk factors:
o Previous fracture (other than skull, facial bone, ankle, finger, and toe) after menopause
o Thinness (body weight < 127 lbs [57.7 kg] or BMI < 21 kg/m2)
o History of hip fracture in a parent
o Current smoking
o Rheumatoid arthritis
o Excessive alcohol intake
* When BMD testing is indicated, DXA is the preferred technique. The total hip, femoral neck, and posterior-anterior lumbar spine should be measured, using the lowest of the three BMD scores.
* The routine use of biochemical markers of bone turnover in clinical practice is not generally recommended.
* Vertebral fracture must be confirmed by lateral spine radiographs or VFA visualization of fracture at the time of BMD testing. Vertebral fracture is confirmed by height loss >20% of the anterior, mid, or posterior dimension of a vertebra on imaging.
* An adequate intake of both calcium and vitamin D is important for bone health and is recognized as an important component of any osteoporosis prescription-drug regimen. NAMS follows the NOF recommendations of calcium intake of 1,200 mg/day for adults age 50 and older, and vitamin D3 of 800 to 1,000 IU/day.
* NAMS recommends osteoporosis drug therapy in the following populations:
o All postmenopausal women who have had an osteoporotic vertebral or hip fracture
o All postmenopausal women who have BMD values consistent with osteoporosis (ie, T-scores ≤−2.5) at the lumbar spine, femoral neck, or total hip region
o All postmenopausal women who have T-scores from −1.0 to −2.5 and a 10-year risk, based on the FRAX calculator, of major osteoporotic fracture (spine, hip, shoulder, and wrist) of at least 20% or of hip fracture of at least 3%
* It is important to encourage adherence to the treatment plan and to identify barriers to nonadherence. Providing clear information to women regarding their risk for fracture and the purpose of osteoporosis therapy may be the optimal way to improve adherence.
* During therapy, it is appropriate to reevaluate the treatment goals and the choice of medication on an ongoing basis through periodic medical examination and a follow-up BMD testing. Measurement of BMD has limited use in predicting the effectiveness of antiresorptive therapies for reducing fracture risk. Also, fracture risk reductions from therapy occur much more rapidly than BMD changes. An appropriate interval for repeat BMD testing is after 1 to 2 years of treatment. There appears to be little value in repeat testing if a woman is stable (within the precision error of the original instrument).
* For untreated postmenopausal women, repeat DXA testing is not useful until 2 to 5 years have passed.
* Bisphosphonates are the first-line drugs for treating postmenopausal women with osteoporosis. They have reduced the risk of vertebral fractures by 40% to 70% and reduced the incidence of nonvertebral fracture, including hip fracture, by about half this amount.
* The SERM raloxifene is most often considered for postmenopausal women with low bone mass or younger postmenopausal women with osteoporosis. It prevents bone loss and reduces the risk of vertebral fractures, but its effectiveness in reducing other fractures is uncertain. Extraskeletal risks and benefits are important when considering raloxifene therapy.
* Teriparatide (PTH 1–34) is best offered to postmenopausal women with osteoporosis who are at high risk for fracture. Daily subcutaneous injections have been shown to stimulate bone formation and improve bone density. Therapy is indicated for no more than 24 months.
* The primary indication for systemic ET/EPT is to treat moderate to severe menopause symptoms (eg, vasomotor symptoms). When symptoms are controlled or cease, continued hormone therapy can still be considered for bone effects, weighing its benefits and risks against those of alternative therapies.
* ET/EPT may be a treatment option for a few years of early postmenopause.
* Calcitonin is not a first-line drug for postmenopausal osteoporosis treatment, as its fracture efficacy is not strong and its BMD effects are less than those of other agents. However, it is an option for women with osteoporosis who are more than 5 years beyond menopause. Calcitonin therapy may reduce vertebral fracture risk in women with osteoporosis, although the evidence documenting fracture protection is not strong. It is not recommended for treating bone pain, except bone pain from acute vertebral compression fractures.
* Data are inadequate to make definitive recommendations regarding combination or serial anabolic and antiresorptive drug therapies.
* The treatment of osteoporosis needs to be long term in most women.
* If drug-related adverse effects occur, appropriate management strategies should be instituted. If adverse effects persist, switching to another agent may be required.
* Decisions to discontinue or suspend therapy are based on the woman's risk of fracture and her response to treatment. Given the uncertainties of long-term drug safety, careful monitoring is required. Fracture risk after discontinuing therapy has not been adequately evaluated.
Use of Estrogen and Progestin in Breast Cancer Patients
Guidelines for Managing Menopausal Symptoms After Breast Cancer: Use of Estrogen and Progestin in Breast Cancer Patients
http://www.medscape.com/viewarticle/581311_2
Use of Estrogen and Progestin in Breast Cancer Patients
Estrogen-containing hormone therapy (HT) is the most effective and well-studied treatment for menopausal vasomotor symptoms and atrophic vaginitis in healthy women,[11] but the efficacy and safety of HT following breast cancer is not established. HT was not effective in controlling hot flashes in tamoxifen users in one retrospective study.[12] Long-term use of combined HT is associated with an increased risk of new breast cancers.[13] The fall in breast cancer incidence seen after 2003 in the United States has been attributed by some to the dramatic drop in HT use following revelation from the Women's Health Initiative study that the risks of HT were not necessarily outweighed by the benefits for healthy women.[13-15] In breast cancer survivors, one randomized controlled trial (RCT) reports a three-fold increased risk of new primary or recurrent breast cancers in HT users.[16] For the two-thirds of women with hormone receptor-positive cancer, a mainstay of treatment is to block the effects of estrogen or reduce its production, and HT may compromise this effect. In addition, combined HT increases breast density, which may compromise the ability of mammography to detect early cancers.[17] Consequently, many women wish to avoid HT following breast cancer.[18] While progestins are effective for menopausal hot flashes following breast cancer,[19-21] their safety is not established. Of concern is that the addition of progestin to estrogen for HT appears to increase the risk of a primary breast cancer.[22]
Tibolone
Tibolone (Livial™, Organon NL) is a synthetic compound with weak estrogenic, progestogenic and androgenic actions. Tibolone (2.5 mg daily) effectively reduces hot flashes[23] and improves vaginal dryness in healthy postmenopausal women. Tibolone may improve sexual function more effectively than standard HT.[24] In the breast, tibolone inhibits the enzyme sulfatase, which regulates the formation of estrogens and hence decreases estrogen stimulation.[25] Tibolone inhibits proliferation of human breast cells and stimulates apoptosis in breast cancer cell lines.[26] The incidence of breast tenderness is low[27] and mammographic density does not increase with tibolone, in contrast to combined HT.[28] The relationship between tibolone use and breast cancer risk is not established. A large observational study suggested an association between tibolone and breast cancer which was less than that seen with combined HT.[29] A large prospective, randomized, placebo-controlled trial of tibolone after breast cancer has recently been halted following reports that the safety of tibolone was not equivalent to placebo (LIBERATE trial, Organon). Tibolone is available in Europe and Australia, but is not in the United States.
Given the evidence for risk or inadequate evidence for safety of available hormonal agents, these are generally avoided following breast cancer. Thus, other options are needed. This presents a clinical conundrum, as nonhormonal therapies have been reported to show only moderate efficacy in treating menopausal hot flashes,[30] and there is little research to date to inform the management of other common menopausal symptoms.
When to Consider Using Estrogen for Menopausal Symptoms Following Breast Cancer
For all women, the use of hormonal treatments for menopausal symptoms is an issue of balancing QoL against risk. For women with no history of breast cancer, the risks of HT appear minimal, particularly for low-risk women taking HT for <5 years.[13] Following breast cancer, current guidelines are to avoid estrogen and tibolone since these may increase the risk of breast cancer recurrence.[124] However, for some women, the benefits of estrogen in terms of symptom reduction and QoL may outweigh these risks.
Ultimately, the decision to take estrogen for severe menopausal symptoms should rest with the patient who is fully informed regarding the potential adverse effects on disease prognosis. A benefit of multidisciplinary care is the ability to calculate individual patient recurrence risks and to use this information in decision making about treatment choices. In addition, if endocrine therapies are producing severe menopausal symptoms with relatively small benefits in terms of recurrence or survival, the multidisciplinary (MD) team may advise that these can reasonably be stopped or adjusted. For women with advanced breast cancer, the issues of QoL are paramount and HT may be considered following discussion with her carers.
http://www.medscape.com/viewarticle/581311_2
Use of Estrogen and Progestin in Breast Cancer Patients
Estrogen-containing hormone therapy (HT) is the most effective and well-studied treatment for menopausal vasomotor symptoms and atrophic vaginitis in healthy women,[11] but the efficacy and safety of HT following breast cancer is not established. HT was not effective in controlling hot flashes in tamoxifen users in one retrospective study.[12] Long-term use of combined HT is associated with an increased risk of new breast cancers.[13] The fall in breast cancer incidence seen after 2003 in the United States has been attributed by some to the dramatic drop in HT use following revelation from the Women's Health Initiative study that the risks of HT were not necessarily outweighed by the benefits for healthy women.[13-15] In breast cancer survivors, one randomized controlled trial (RCT) reports a three-fold increased risk of new primary or recurrent breast cancers in HT users.[16] For the two-thirds of women with hormone receptor-positive cancer, a mainstay of treatment is to block the effects of estrogen or reduce its production, and HT may compromise this effect. In addition, combined HT increases breast density, which may compromise the ability of mammography to detect early cancers.[17] Consequently, many women wish to avoid HT following breast cancer.[18] While progestins are effective for menopausal hot flashes following breast cancer,[19-21] their safety is not established. Of concern is that the addition of progestin to estrogen for HT appears to increase the risk of a primary breast cancer.[22]
Tibolone
Tibolone (Livial™, Organon NL) is a synthetic compound with weak estrogenic, progestogenic and androgenic actions. Tibolone (2.5 mg daily) effectively reduces hot flashes[23] and improves vaginal dryness in healthy postmenopausal women. Tibolone may improve sexual function more effectively than standard HT.[24] In the breast, tibolone inhibits the enzyme sulfatase, which regulates the formation of estrogens and hence decreases estrogen stimulation.[25] Tibolone inhibits proliferation of human breast cells and stimulates apoptosis in breast cancer cell lines.[26] The incidence of breast tenderness is low[27] and mammographic density does not increase with tibolone, in contrast to combined HT.[28] The relationship between tibolone use and breast cancer risk is not established. A large observational study suggested an association between tibolone and breast cancer which was less than that seen with combined HT.[29] A large prospective, randomized, placebo-controlled trial of tibolone after breast cancer has recently been halted following reports that the safety of tibolone was not equivalent to placebo (LIBERATE trial, Organon). Tibolone is available in Europe and Australia, but is not in the United States.
Given the evidence for risk or inadequate evidence for safety of available hormonal agents, these are generally avoided following breast cancer. Thus, other options are needed. This presents a clinical conundrum, as nonhormonal therapies have been reported to show only moderate efficacy in treating menopausal hot flashes,[30] and there is little research to date to inform the management of other common menopausal symptoms.
When to Consider Using Estrogen for Menopausal Symptoms Following Breast Cancer
For all women, the use of hormonal treatments for menopausal symptoms is an issue of balancing QoL against risk. For women with no history of breast cancer, the risks of HT appear minimal, particularly for low-risk women taking HT for <5 years.[13] Following breast cancer, current guidelines are to avoid estrogen and tibolone since these may increase the risk of breast cancer recurrence.[124] However, for some women, the benefits of estrogen in terms of symptom reduction and QoL may outweigh these risks.
Ultimately, the decision to take estrogen for severe menopausal symptoms should rest with the patient who is fully informed regarding the potential adverse effects on disease prognosis. A benefit of multidisciplinary care is the ability to calculate individual patient recurrence risks and to use this information in decision making about treatment choices. In addition, if endocrine therapies are producing severe menopausal symptoms with relatively small benefits in terms of recurrence or survival, the multidisciplinary (MD) team may advise that these can reasonably be stopped or adjusted. For women with advanced breast cancer, the issues of QoL are paramount and HT may be considered following discussion with her carers.
Friday, July 2, 2010
Psychotropic Medications Linked to Serious Adverse Drug Reactions in Children
From Medscape Medical News
Deborah Brauser
July 2, 2010 — Psychotropic medications are associated with adverse drug reactions (ADRs), many of which are serious, in children younger than 17 years, according to a new database study from Danish researchers.
Results also showed that all but one of the psychotropic-related ADRs for children between the ages of birth and 2 years were serious, including birth defects such as neonatal withdrawal syndrome, ventricular septal defects, and premature labor.
These findings were "probably due to the mothers' intake of psychotropic medicine, primarily antidepressants and antipsychotics, during pregnancy," write the study authors.
For the overall patient population, the largest share of reported ADRs came from psychostimulants (42%), followed by antidepressants (31%) and antipsychotics (24.5%).
"The high number of serious ADRs reported for psychotropic medicines in the pediatric population should be a concern for health care professionals and physicians," the study authors write.
In addition, "clinicians must be aware of the risks for the unborn child if they treat pregnant women with [these drugs]," coinvestigator Ebba Hansen, MSc, professor of social pharmacy and director for the FKL-Research Center for Quality in Medicine Use at the University of Copenhagen, Denmark, told Medscape Medical News.
She noted that many of the general practitioners interviewed for this study "thought that SSRI [selective serotonin reuptake inhibitor] antidepressants are harmless. Therefore, we recommend that treatment of pregnant women with psychotropic drugs should be an issue for specialists only."
The study is published online in BMC Research Notes.
ADR Evidence Lacking
Although regulatory authorities have issued warnings about risks associated with the use of psychotropics in pediatric patients, "little evidence has been reported about the ADRs of these medicines in practice," write the study authors.
"Overall, we have very little information about [ADRs] in children, and especially in infants, as vulnerable groups are excluded from the clinical trials that document a medication's efficacy and safety before licensing and marketing," said Professor Hansen.
For this study, her team evaluated 4500 ADRs in children listed in the national Danish ADR database between 1998 and 2007.
"Spontaneous ADR reporting [is] an important contributor to knowledge about safety of medicines," the study authors write. They note that spontaneous reports are "the main source for information about new and previous unknown ADRs."
Serious ADRs Found
Results showed that 429 of the ADRs reported during the study period were for psychotropic medications. Of these, 241 (56%) were deemed serious.
A total of 50% of the psychotropic ADRs reported were for adolescents between the ages of 11 and 17 years (n = 214), of which 45% were serious. Almost 19% were for children between the ages of birth and 2 years (n = 80).
In addition, 39% of the overall psychotropic-related ADRs were from the "nervous and psychiatric disorders" categories. When looking at sex, 59% of the total ADRs reported were for boys.
A total of 79 of the 80 ADRs associated with psychotropics in the children younger than 2 years were serious, and 2 of these were fatal (one was associated with citalopram due to chorioamnionitis and the other with fluoxetine due to persistent fetal circulation).
Finally, 40% of all psychotropic ADRs were associated with the psychostimulants methylphenidate and atomoxetine, whereas 59% of the ADRs reported for antipsychotics were associated with ziprasidone, olanzapine, and risperidone. A total of 61% of the total ADRs reported for antidepressants were with sertraline and citalopram.
When asked about her team's upcoming plans for further research, Professor Hansen reported that 2 studies on ADRs in children associated with vaccines and use of antibiotics have recently been completed — and that both articles are currently pending review. In addition, a new study on ADRs in children treated with psychostimulants is "in the pipeline.
"An interesting idea for study would also be to follow up on the children who were attacked by ADRs [in this study] and see if there are any long-term effects, such as cognitive disturbances," she added.
The study authors have disclosed no relevant financial relationships.
BMC Res Notes. Posted online June 23, 2010.
Deborah Brauser
July 2, 2010 — Psychotropic medications are associated with adverse drug reactions (ADRs), many of which are serious, in children younger than 17 years, according to a new database study from Danish researchers.
Results also showed that all but one of the psychotropic-related ADRs for children between the ages of birth and 2 years were serious, including birth defects such as neonatal withdrawal syndrome, ventricular septal defects, and premature labor.
These findings were "probably due to the mothers' intake of psychotropic medicine, primarily antidepressants and antipsychotics, during pregnancy," write the study authors.
For the overall patient population, the largest share of reported ADRs came from psychostimulants (42%), followed by antidepressants (31%) and antipsychotics (24.5%).
"The high number of serious ADRs reported for psychotropic medicines in the pediatric population should be a concern for health care professionals and physicians," the study authors write.
In addition, "clinicians must be aware of the risks for the unborn child if they treat pregnant women with [these drugs]," coinvestigator Ebba Hansen, MSc, professor of social pharmacy and director for the FKL-Research Center for Quality in Medicine Use at the University of Copenhagen, Denmark, told Medscape Medical News.
She noted that many of the general practitioners interviewed for this study "thought that SSRI [selective serotonin reuptake inhibitor] antidepressants are harmless. Therefore, we recommend that treatment of pregnant women with psychotropic drugs should be an issue for specialists only."
The study is published online in BMC Research Notes.
ADR Evidence Lacking
Although regulatory authorities have issued warnings about risks associated with the use of psychotropics in pediatric patients, "little evidence has been reported about the ADRs of these medicines in practice," write the study authors.
"Overall, we have very little information about [ADRs] in children, and especially in infants, as vulnerable groups are excluded from the clinical trials that document a medication's efficacy and safety before licensing and marketing," said Professor Hansen.
For this study, her team evaluated 4500 ADRs in children listed in the national Danish ADR database between 1998 and 2007.
"Spontaneous ADR reporting [is] an important contributor to knowledge about safety of medicines," the study authors write. They note that spontaneous reports are "the main source for information about new and previous unknown ADRs."
Serious ADRs Found
Results showed that 429 of the ADRs reported during the study period were for psychotropic medications. Of these, 241 (56%) were deemed serious.
A total of 50% of the psychotropic ADRs reported were for adolescents between the ages of 11 and 17 years (n = 214), of which 45% were serious. Almost 19% were for children between the ages of birth and 2 years (n = 80).
In addition, 39% of the overall psychotropic-related ADRs were from the "nervous and psychiatric disorders" categories. When looking at sex, 59% of the total ADRs reported were for boys.
A total of 79 of the 80 ADRs associated with psychotropics in the children younger than 2 years were serious, and 2 of these were fatal (one was associated with citalopram due to chorioamnionitis and the other with fluoxetine due to persistent fetal circulation).
Finally, 40% of all psychotropic ADRs were associated with the psychostimulants methylphenidate and atomoxetine, whereas 59% of the ADRs reported for antipsychotics were associated with ziprasidone, olanzapine, and risperidone. A total of 61% of the total ADRs reported for antidepressants were with sertraline and citalopram.
When asked about her team's upcoming plans for further research, Professor Hansen reported that 2 studies on ADRs in children associated with vaccines and use of antibiotics have recently been completed — and that both articles are currently pending review. In addition, a new study on ADRs in children treated with psychostimulants is "in the pipeline.
"An interesting idea for study would also be to follow up on the children who were attacked by ADRs [in this study] and see if there are any long-term effects, such as cognitive disturbances," she added.
The study authors have disclosed no relevant financial relationships.
BMC Res Notes. Posted online June 23, 2010.
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