Wednesday, April 10th, 2013
The Food and Drug Administration has approved the return of a drug that was widely used to treat morning sickness until it came off the market 30 years ago. Bendectin, now called Diclegis, will return to the market in early July after extensive study has shown it is safe and effective. Time.com has more:
Monday’s FDA decision means a new version of the pill once called Bendectin is set to return to U.S. pharmacies under a different name — Diclegis — as a safe and effective treatment for this pregnancy rite of passage.
In the intervening decades, the treatment is widely believed to have undergone more scrutiny for safety than any other drug used during pregnancy.
“There’s been a lot of buzz about this. Nothing better has come along” to treat morning sickness in those 30 years, said Dr. Edward McCabe, medical director for the March of Dimes, who welcomed the step.
“We know safety-wise, there’s zero question,” said Dr. Gary Hankins of the University of Texas Medical Branch in Galveston, who headed one of the company-financed studies of Diclegis that led to its approval.
U.S. sales of Diclegis are expected to begin in early June, according to Canada-based manufacturer Duchesnay Inc. The company has long sold a generic version of the pill in Canada under yet another name, Diclectin.
For all the names, the main ingredients are the same: Vitamin B6 plus the over-the-counter antihistamine doxylamine, found in the sleep aid Unisom. U.S. obstetricians have long told nauseated pregnant women how to mix up the right dose themselves.
In fact, in 2004 the American College of Obstetricians and Gynecologists issued guidelines calling the combination a first-line therapy.
The difference that prescription-only Diclegis would offer: Combining both ingredients with a delayed-release coating designed to help women take a daily dose before their nausea sets in.
This news follows a Danish study last month that showed that Zofran, another morning sickness medication, is also safe.
Image: Woman suffering from nausea, via Shutterstock
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Monday, March 4th, 2013
Exposure to the chemical bisphenol A, which is found in some plastics, food cans, and a number of other consumer products, has been linked with a higher risk of childhood asthma, a new study conducted by researchers at the Columbia Center for Children’s Environmental Health has found. More from CNN:
A child’s chances of suffering with asthma were increased if BPA was detected in their urine samples at ages 3, 5 and 7. In addition, when BPA was measured in urine at age 3, the chances of wheezing by ages 5 and 6 were increased. Same thing for 7-year-olds: BPA meant later problems with wheezing.
An exception to the findings occurred among children with BPA measured in their urine at 5 years of age; those children did not have problems with wheezing during follow-ups one or two years later.
“What is important is that we were seeing the association at routine low doses of exposure,” said Dr. Kathleen Donohue, the lead study author.
One anomalous finding in the study, published Friday in the Journal of Allergy and Clinical Immunology: If BPA was detected in a mother’s urine during her third trimester of pregnancy, there was less likelihood that her child would have breathing problems at age five – the opposite of what researchers expected.
Government agencies consider BPA to be a product of concern, but have stopped short of banning it in all consumer products. Last year, the FDA banned BPA from all baby bottles and sippy cups.
Image: Child with asthma, via Shutterstock
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Wednesday, February 6th, 2013
The Food and Drug Administration has issued a warning against a common thickener used to help premature babies better consume and digest their food. The warning states that SimplyThick has a risk of causing necrotizing enterocolitis, or NEC, a life-threatening condition that damages intestinal tissue. More from The New York Times:
An F.D.A. investigation of 84 cases, published in The Journal of Pediatrics in 2012, found a “distinct illness pattern” in 22 instances that suggested a possible link between SimplyThick and NEC. Seven deaths were cited; 14 infants required surgery.
Last September, after more adverse events were reported, the F.D.A. warned that the thickener should not be given to any infants. But the fact that SimplyThick was widely used at all in neonatal intensive care units has spawned a spate of lawsuits and raised questions about regulatory oversight of food additives for infants.
SimplyThick is made from xanthan gum, a widely-used food additive on the F.D.A.’s list of substances “generally recognized as safe.” SimplyThick is classified as a food and the F.D.A. did not assess it for safety.
John Holahan, president of SimplyThick, which is based in St. Louis, acknowledged that the company marketed the product to speech language pathologists who in turn recommended it to infants. The patent touted its effectiveness in breast milk.
However, Mr. Holahan said, “There was no need to conduct studies, as the use of thickeners overall was already well established. In addition, the safety of xanthan gum was already well established.”
Image: Infant holding a bottle, via Shutterstock
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Friday, January 11th, 2013
The Food and Drug Administration has approved a new intrauterine device (IUD), the first such new approval in 12 years, Reuters is reporting:
The T-shaped polyethylene device is designed to prevent pregnancy for 3 years, during which time it releases a diminishing dosage of progestin, according to Bayer documents.
The proportion of women using long-acting reversible contraceptive methods such as an intrauterine device (IUD) climbed to 7.7 percent in 2009 up from 2.0 percent in 2002, according a 2012 study by the Guttmacher Institute, a reproductive health and rights organization based in New York.
The highest level of use was among women aged 25-39 and those who already had at least one child.
The IUD, called Skyla, is aimed at younger women who have not had children. During a trial of 1,432 women aged 18 to 35 years, the rate of pregnancy over a three-year period was 0.9 per 100 women, and 77 percent of women wishing to become pregnant did so within 12 months of its removal, Bayer documents said.
“Over half of all pregnancies in the U.S. are unintended and there’s just a need out there to have effective birth control,” said Pamela Cyrus, Bayer’s head of medical affairs said in an interview.
Image: Woman talking to her doctor, via Shutterstock
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Wednesday, July 18th, 2012
The chemical compound bisiphenol-A, otherwise known as BPA, can no longer be used to make baby bottles and sippy cups because of health and safety concerns, the Food and Drug Administration has announced. Every major manufacturer of bottles and sippy cups has already stopped using BPA, and parents are familiar with “BPA Free” labels on those and other plastic products.
MSNBC.com reports on the ruling, which was requested by the U.S. chemical industry’s chief association, the American Chemistry Council in October:
The chemical industry’s request may help curb years of negative publicity from consumer groups and head off tougher laws that would ban BPA from other types of packaging because of health worries.
Legislation introduced by some members of Congress would ban BPA nationwide in all canned food, water bottles and food containers. Chemical makers maintain that the plastic-hardening chemical is safe for all food and drink uses.
BPA is found in hundreds of plastic items from water bottles to CDs to dental sealants. Some researchers say ingesting the chemical can interfere with development of the reproductive and nervous systems in babies and young children. They point to dozens of studies showing such an effect from BPA in rodents and other animals.
But the FDA has repeatedly stated that those findings cannot be applied to humans. The federal government is currently spending $30 million on its own studies assessing the chemical’s health effects on humans.
Image: Baby bottle, via Shutterstock.
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