Category: A.M. Vitals: FDA Will Restrict Use of Certain Antibiotics in Livestock

MEwens
Antibiotics in Livestock: The FDA said it will ban the use of antibiotics called cephalosporins to prevent disease in livestock, though the drugs can still be used to treat illnesses in the animals, the WSJ reports. The agency — and other experts — are concerned that over- or misuse of the drugs can […]

MEwens
Infant Formula Test Results: The FDA and CDC said late Friday that tests of factory-sealed Mead Johnson infant formula pulled from some store shelves after a Missouri infant died from a rare infection showed no traces of bacterial contamination, the WSJ reports. The agencies said there was no need for a recall of […]

MEwens
Planning Access: Federal officials are working on a draft plan that would allow the public to access limited versions of two studies on a deadly strain of H5N1, or bird flu, while permitting qualified scientists to access the full data, the WSJ reports. Still, it’s not clear who would determine access levels, the […]

MEwens
The FDA said it approved an external pump with implantable tubes to keep kids’ hearts going while they await a transplant.
The official name for the device is the Excor Pediatric System. But it’s commonly known by the name of its manufacturer, a German company called Berlin Heart.
Heart failure in kids is far less […]

MEwens
Central to the drug-shortage issue is a chicken-and-egg question that often leaves legislators scratching their heads at congressional hearings.
Chicken: Are the shortages of crucial drugs caused by factory flaws and shutdowns? Or egg: Are shortages somehow caused by economics, like the thin profit margins of generic drugs?
A federal report to be released Thursday […]

MEwens
Easing Heart Fears?: Research published online by the Journal of the American Medical Association suggests no increased risk for serious heart problems in adults stemming from drugs to treat attention deficit-hyperactivity disorder, the WSJ reports. While a study author notes the research doesn’t prove the drugs are safe, it could — especially when […]

MEwens
Weighing the Risks: An outside FDA advisory panel is recommending clearer language covering the potential risks of blood clots on the labels of some birth-control pills, though a majority of panel members said the benefits of the pills outweigh the risks, the WSJ reports. Studies attempting to figure out whether Bayer AG’s Yaz, […]

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Drugs for Late-Stage Breast Cancer: Research presented at the San Antonio Breast Cancer Symposium and published online by the New England Journal of Medicine shows that adding two drugs to standard therapy for metastatic breast cancer can halt tumor growth for several months, the WSJ reports. One study found that adding Roche’s pertuzumab […]

MEwens
The good news for Teva: the FDA agreed with the pharma company that Plan B One-Step, a pill intended to prevent potential implantation of a fertilized egg, should be sold over the counter and without a prescription to teens younger than 17.
The bad news for Teva, as the WSJ reports: HHS head Kathleen […]

MEwens
Breast-Cancer Developments: Research presented at the San Antonio Breast Cancer Symposium found that a genetic test called Oncotype DX can help pinpoint the patients with ductal carcinoma in situ, a very early form of breast cancer, who stand to benefit from post-surgical radiation treatment, the WSJ reports. Meantime, a separate study found that […]