Tuesday, November 24, 2009

Govt issues record 2.1M recall for dropside cribs

By JENNIFER C. KERR, Associated Press

WASHINGTON – More than 2.1 million drop-side cribs by Stork Craft Manufacturing are being recalled, the biggest crib recall in U.S history, following reports of four infant suffocations.

The Consumer Product Safety Commission said late Monday the recall involves 1.2 million cribs in the United States and almost 1 million in Canada, where Stork Craft is based. Sales of the cribs being recalled go back to 1993.

Nearly 150,000 of the cribs carry the Fisher-Price logo.

The CPSC said it is aware of four infants who suffocated in the drop-side cribs, which have a side that moves up and down to allow parents to lift children from the cribs more easily. The agency also said there have been 110 incidents of drop-sides detaching from the cribs.

The Stork Craft cribs have had problems with their hardware, which can break, deform or become missing after years. CPSC said there can also be problems with assembly mistakes by the crib owner. These problems can cause the drop-side to detach, creating a dangerous space between the drop-side and the crib mattress, where a child can become trapped.

The commission is urging parents to stop using the cribs until receiving a free repair kit from Stork Craft. The kit will convert the drop-side into a fixed side.

The cribs, which were manufactured and distributed between January 1993 and October 2009, were sold at major retailers including BJ's Wholesale Club, Sears and Wal-Mart stores and online through Target and Costco. They sold for between $100 and $400, and were made in Canada, China and Indonesia.

Calls to Stork Craft were not immediately returned.

This is the second big recall this year for the company. It recalled about 500,000 cribs in January because of problems with the metal brackets that support the mattress. Some of the same models in the earlier recall were also part of Monday's announcement, CPSC said.

Consumer advocates have complained for years about drop-side cribs. More than 5 million of them have been recalled over the past two years alone — recalls that were associated with the deaths of a dozen young children.

ASTM International, an organization that sets voluntary industry safety standards for everything from toys to the steel used in commercial buildings, approved a new standard last week that requires four immovable, or fixed, sides for full-size cribs — essentially eliminating the manufacture of drop-side cribs.

CPSC is also considering new rules for making cribs safer and could adopt the ASTM voluntary standard as a mandatory one, outright banning the cribs.

Nancy Cowles, executive director of Chicago-based Kids In Danger, said the agency must include more rigorous testing for crib durability. "Parents should be able to trust that their child is safe in their crib," said Cowles.

Toys"R"Us started phasing out drop-side cribs earlier this year and will no longer carry them next month.

In the Stork Craft recall, the manufacture date, model number, crib name, country of origin, and the firm's name, address and contact information are located on the assembly instruction sheet attached to the mattress support board. The firm's insignia "storkcraft baby" or "storkling" is inscribed on the drop-side teething rail of some cribs.

Consumers can contact the company, 877-274-0277, to order the free repair kit, or log on to http://www.storkcraft.com.

Sunday, November 22, 2009

Pain Control Recommended for Newborns

From Medscape Medical News CME

News Author: Laurie Barclay, MD
CME Author: Penny Murata, MD

November 11, 2009 — Feeding and breast-feeding newborns are found to be the most effective methods of pain relief during heel-lancing, according to the results of a prospective study reported in the November issue of Pediatrics.

"Pain experience can alter clinical outcome, brain development, and subsequent behavior in newborns, primarily in preterm infants," write Amir Weissman, MD, from Technion-Israel Institute of Technology in Haifa, Israel, and colleagues. "The aims of this study were (1) to evaluate several simple, commonly used methods for pain control in newborns and (2) to evaluate the concordance between behavioral and autonomic cardiac reactivity to pain in term neonates during heel-lancing."

During heel-lancing for routine neonatal screening of phenylketonuria and hypothyroidism, 180 term newborn infants were randomly selected to 1 of 6 groups: (1) control (no intervention for pain relief); (2) sucking without feeding; (3) holding by mother; (4) ingestion of oral glucose solution; (5) feeding with oral formula; or (6) breast-feeding. Response to pain was assessed with the Neonatal Facial Coding System score; duration of crying; and autonomic variables determined from spectral analysis of heart rate variability before, during, and after heel-lancing.

Compared with newborns in any of the 5 intervention groups, those in the control group with no pain intervention had the greatest levels of pain manifestation. Breast-feeding or feeding with oral formula appeared to be most effective vs all other groups, based on the lowest increase in heart rate (21 and 23 beats per minute, respectively, vs 36 beats per minute; P < .01), neonatal facial score (2.3 and 2.9, respectively, vs 7.1; P < .001), cry duration (5 and 13 seconds, respectively, vs 49 seconds; P < .001), and the lowest decrease in parasympathetic tone (–2 and –2.4, respectively, vs 1.2; P < .02).

"Any method of pain control is better than none," the study authors write. "Feeding and breast-feeding during heel-lancing were found to be the most effective methods of pain relief."

Limitations of this study include low sensitivity of the pain assessment methods, large variability of newborn response to painful stimuli, and the subjective nature of interpreting these data.

"Neonatal pain prevention is the expectation of the parents and should be the goal of the medical staff; therefore, family members or staff may be recruited to help during these procedures, and nursing mothers should be encouraged to breastfeed during the procedure," the study authors conclude. "If family members believe that they cannot withstand the procedure, hear their infant crying, or see the heel-lancing, then bottle-feeding seems to be a good alternative."

The study authors have disclosed no relevant financial relationships.

Pediatrics. 2009;124:e921-e926.

Bottled Water a Risk Factor for Early Childhood Caries

From Medscape Medical News
Crina Frincu-Mallos, PhD

November 18, 2009 (Philadelphia, Pennsylvania) — Drinking bottled water was the only modifiable risk factor related to early childhood caries (ECC) in a retrospective investigation presented here at the American Public Health Association 137th Annual Meeting by Rosalia A. Mendoza, MD, MPH, assistant professor in the Department of Family and Community Medicine at the University of California at San Francisco.

The study was prompted by the fact that 62% of children referred to an oral health clinic in the San Francisco area had caries by the age of 2 years. More than half of them drank bottled water, from which fluoride is usually removed, together with impurities, by reverse osmosis.

Currently, 69% of the American population lives in communities served by fluoridated public water supply systems, according to the Centers for Disease Control and Prevention.

"There appears to be a protective effect of drinking the fluoridated tap water over drinking bottled water" (odds ratio [OR], 0.59; P = .07), Dr. Mendoza reported.

In their retrospective analysis, Dr. Mendoza and colleagues aimed to identify risks and protective factors associated with untreated ECC at an urban San Francisco Family Health Center, which serves more than 8000 children 5 years and younger annually. ECC seem to be more prevalent among African American and Latino children in the San Francisco area.

Living in Fluoridated Communities Does Not Translate Into Fluoride Exposure

Between June 2006 and April 2009, 239 children (114 girls and 125 boys), 70% of whom were Latino, were referred to the oral health screening clinic at a San Francisco Family Health Center by family medicine physicians. The physicians had identified cavitated and noncavitated caries. They also interviewed parents about the oral health status of the child and the child's behavior. The investigators looked for ECC risk factors, such as more than 3 sugary snacks or drinks consumed per day, and ECC protective factors, such as whether the parent sees a dentist regularly, the child's teeth are brushed with fluoride toothpaste, and the child drinks tap water.

Drinking bottled water was "the only associated and modifiable risk factor" that the investigators found.

Family medicine physicians have an "important role during the early screening and referral to dentists," said Dr. Mendoza in an interview with Medscape Public Health & Prevention. "Frequent visits in the first and second year of life, following the vaccine schedule for preventive care," can be used to incorporate early regular oral care.

"We are very successful [in] detecting some of the modifiable risk behaviors and protective behaviors," said Dr. Mendoza. For instance, bottled water vs tap water preferences and practices are currently not part of state surveys.

Interestingly, "there also appears to be an association between a dental home and caries prevalence in this community," Dr. Mendoza observed.

At-Home Water Filtration Recommended

Dr. Mendoza and colleagues are trying to assess how well immigrant families understand the importance of fluoride. "Do they know that fluoride is part of their tap water, the municipal water, which is free?" she said. Her team wants to find out what the barriers are "that we need to overcome in our health promotion to facilitate greater tap water consumption in this community."

Most families believed that milk or water is a healthier choice than juice, she said, but "they chose to use bottled water, not water from the tap, to add to formula milk or to aguas frescas."

At the core of the practice of giving bottled water to children seems to be the perception that "the water [in the United States] is not safe. If you do live in a rental property, if you know there is sediment in the tap water or if you don't like the taste, how do you address that?" asked Dr. Mendoza: "You use a filter!"

Need for Monitoring of Tap Water Drinking Habits

Next, the researchers are going to "push the importance of bottled water preferences and practice into our national and state surveys," said Dr. Mendoza.

"In our local community, we are going to be looking at ways that we can do successful public health promotion around these identified areas in immigrant practices and beliefs around bottled water," she added.

"It was interesting to see how family physicians can deliver the message that fluoridated water can help protect teeth from caries," said Jeffrey Johnston, public health analyst in the Office of Operations, Health Resources and Services Administration in Rockville, Maryland, who attended the meeting. "Hopefully, now we can implement some service-delivery changes," he concluded.

Dr. Mendoza and Mr. Johnston have disclosed no relevant financial relationships.

American Public Health Association (APHA) 137th Annual Meeting: Abstract 204297. Presented November 8, 2009.

Thursday, November 19, 2009

New Breast Cancer Screening Guidelines Opposed by Societies

From Medscape Medical News

Laurie Barclay, MD


November 19, 2009 — Several professional organizations and expert groups have voiced their objections to new recommendations for breast cancer screening issued by the US Preventive Services Task Force (USPSTF) and published in the November 17 issue of the Annals of Internal Medicine.

"[The American Cancer Society] continues to recommend [mammography] screening annually for women 40 to 49 years of age," Victor G. Vogel, MD, MHS, FACP, national vice president for research at the American Cancer Society (ACS) in Atlanta, Georgia, told Medscape Medical News. "Clinicians should recognize that very few agencies, including the ACS, are altering their screening guidelines based on the USPSTF modeling results, which simply reanalyze previously published data."

Based on an evidence review, the updated USPSTF guidelines recommend against routine mammography screening for women before age 50 years, suggest that screening end at age 74 years, and recommend changing the screening interval from 1 year to 2 years.

In addition to the ACS, the American College of Radiology (ACR), the American College of Obstetricians and Gynecologists (ACOG), and several other expert groups recommend that clinicians and patients continue to follow earlier guidelines (see Table below for a detailed comparison with ACS guidelines). The ACS recommendations call for annual mammograms starting at age 40 years and continuing for as long as a woman is in good health; ACS has no specific upper age at which mammography screening should be discontinued. The society suggests that the decision to stop regular mammography screening should be individualized based on patient-specific, potential benefits and risks of screening within the context of overall health and estimated lifespan.

ACOG's recommendations are similar, except that mammography is recommended every 1 to 2 years from ages 40 to 49 years.

"We would urge primary care clinicians to continue to observe the ACR and ACS mammography guidelines and to talk with their patients regarding the benefits of mammography and any concerns their patients may have," M. Shawn Farley, ACR's director of public affairs, told Medscape Medical News.

Supporting Evidence

Dr. Vogel cited several lines of evidence supporting the ACS position, including evidence that early detection of breast cancer saves lives or improves survival (JAMA. 1995;273[2]:149–154).

"If the USTSF recommendations are adopted as policy — particularly if Medicare and private insurers try to use them as an excuse to cut cost — many women will die unnecessarily from breast cancer," Mr. Farley said. "The treatment costs associated with the disease may rise because cancers would be found at a more advanced stage. For those women diagnosed at a later stage, they may experience more invasive techniques to remove the cancers because the disease is more advanced."

http://www.medscape.com/viewarticle/712720?sssdmh=dm1.558850&src=nldne&uac=71630FV

Monday, November 2, 2009

Drugs to treat urinary infections could cause heart, brain problems

Nov. 2, 2009 Associated Press

CHICAGO - Researchers studying antibiotics in pregnancy have found a surprising link between common drugs used to treat urinary infections with birth defects. Reassuringly, the most-used antibiotics in early pregnancy — penicillins — appear to be the safest.

Bacterial infections themselves can cause problems for the fetus if left unchecked, experts said, so pregnant women shouldn't avoid antibiotics entirely. Instead, women should discuss antibiotics choices with their doctors.

The new study is the first large analysis of antibiotic use in pregnancy. It found that mothers of babies with birth defects were more likely than mothers with healthy babies to report taking two types of antibiotics during pregnancy: sulfa drugs (brand names include Thiosulfil Forte and Bactrim) and urinary germicides called nitrofurantoins (brand names include Furadantin and Macrobid).

It was the first time an association had been seen between urinary tract treatments and birth defects, said lead author Krista Crider, a geneticist with the Centers for Disease Control and Prevention, which funded the research. "Additional studies are going to need to be done to confirm these findings."
Before rigorous safety testing
Used for many decades, the antibiotics in question predate the Food and Drug Administration and its requirements for rigorous safety testing. The FDA now grades all drugs for safety to the fetus based on available research, but rigorous studies are so lacking in many cases, that no antibiotics get the highest grade of "A."
Sulfa drugs are the oldest antibiotics and some animal studies have found harm during pregnancy. Nitrofurantoins previously have been viewed by doctors as safe to treat urinary tract infections during pregnancy.
The study, appearing in November's Archives of Pediatrics and Adolescent Medicine, may cause doctors to change the drugs they choose to treat pregnant women with infections. The findings were released Monday.
Dr. Susan Mehnert-Kay, a family practice doctor in Tulsa, Okla., who has written about diagnosing and managing urinary tract infections, said the research is "very interesting" and would cause her to reconsider antibiotic choices in early pregnancy.
The study is important because it looked at drugs that have been used for decades without large studies of their safety in pregnant women, said Dr. Michael Katz of the March of Dimes.
"Some physicians are not as attuned to this as they ought to be, so patients have the right to ask questions," Katz said.
The researchers analyzed data from more than 13,000 mothers whose infants had birth defects and nearly 5,000 women who lived in the same regions with healthy babies.
The women were interviewed by phone from six weeks to two years after their pregnancies. Those who remembered taking antibiotics during the month before conception through the first three months of pregnancy were identified as exposed to antibiotics.
The women's memories could have been faulty, a substantial weakness of the study, which the authors acknowledged. About one-third of the women who took antibiotics couldn't remember the specific type of drug they took.
It's also unclear whether the birth defects were caused by the drugs or by the underlying infections being treated, Crider said.
Birth defects linked to sulfa drugs included rare brain and heart problems, and shortened limbs. Those linked to nitrofurantoins included heart problems and cleft palate. The drugs seemed to double or triple the risk, depending on the defect.
"These defects are rare. Even with a threefold increase in risk, the risk for the individual is still quite low," Crider said.