Archive for December, 2009

FDA to study safety of drugs taken during pregnancy

Citing a lack of clinical trials to determine how medications affect mothers and unborn children, the FDA said it will collaborate with other researchers in the new study, called the Medication Exposure in Pregnancy Risk Evaluation Program. The agency said data shows that about two-thirds of women who deliver a baby have taken at least one prescription medication during pregnancy.

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Studies find FDA medical-device approval flawed

Two new studies find shortfalls in the Food and Drug Administration’s approval process for heart devices such as pacemakers and stents. Safety targets often weren’t clearly spelled out in the research submitted by devicemakers and important patient information was missing, according to one study. A separate analysis found heart devices frequently got the FDA’s blessing based on research done outside the United States. Many device studies lacked standards most scientists expect: randomization and a clear goal. The FDA is taking a close look at its device program and wants manufacturers to adhere to tougher research guidelines that will be out in 2010.

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Johnson & Johnson expands voluntary recall of Tylenol Arthritis Pain caplets

Johnson & Johnson, the makers of Tylenol Arthritis Pain caplets, is expanding a voluntary recall of the product because of consumer complaints of a strange, moldy smell that has caused nausea and other ailments. The health care company, based in New Brunswick, N.J., is now recalling all 100-count bottles of the arthritis caplets with the red E-Z Open Cap. Last month, Johnson & Johnson recalled five lots of the pain medicine after consumers complained of a mildew-like odor from the pills that produced nausea, vomiting, stomach pain and diarrhea.

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J&J expands recall of Tylenol arthritis caplets

A voluntary recall of Tylenol Arthritis Pain Caplets is being expanded because of consumer reports of an unusual moldy odor with the 100-count bottles, the U.S. Food and Drug Administration said late on Monday. The FDA said it and Johnson & Johnson were expanding the recall to all available product lots of the pain caplets with the distinctive red EZ-open cap. The initial recall involved five lots of the product in November after reports of an unusual musty or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea, the FDA said.

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Women warned about morning sickness remedy

The Texas Department of State Health Services issued a warning this week that pregnant and breastfeeding women should avoid using of a product called “Nzu,” also known as Calabash chalk. The product is a traditional remedy for morning sickness used largely by Nigerian and West African women. It can also be used as a cosmetic. Laboratory analysis in Texas, mirroring earlier findings in the UK and Canada, show the products contain high levels of lead and arsenic.

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Nestle made misleading drink health claims: FDA

The Food and Drug Administration, in a December 4 letter, said Nestle made unauthorized nutrient content claims on certain Juicy Juice products marketed for children under age 2. In a separate December 3 letter, the FDA said Nestle’s Boost Kid Essentials Nutritionally Complete Drink, in vanilla, chocolate and strawberry flavors, was promoted as a “medical food” but did not meet requirements for that type of claim.

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Not All Drugs Are the Same After All

When a name-brand drug’s patent expires, other manufacturers are generally free to create their own version of that product. If a drug is popular, a dozen or more companies may rush in to create a copy of it. But there is a gnawing concern among some doctors and researchers that certain prescription generic drugs may not work as well as their brand-name counterparts.

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