Scandal Over Mediator, a French Weight-Loss Drug, Prompts Calls for Wide Changes
Mediator and its French manufacturer, Laboratoires Servier, find themselves at the center of France’s largest public-health scandal in at least a decade over a weight-loss drug that, according to estimates by health officials, was linked to the deaths of 2,000 people, with thousands more hospitalized, victims of cardiac valve damage and pulmonary hypertension.
Sebelius overrules FDA; declares Plan B cannot be sold over-the-counter
Dr. Margaret Hamburg, the F.D.A.’s commissioner, issued a lengthy statement saying it was safe to sell Plan B over the counter, while Ms. Sebelius countered that the drug’s manufacturer had failed to study whether girls as young as 11 years old could safely use Plan B, reports the New York Times.
FDA examining the safety claims of several new birth control drugs
The drugs, which were claiming to have fewer side effects and be able to clear up acne, may cause blood clots.
FDA likely to require stronger cautions on bone-building drugs for women
Two of the Food and Drug Administration’s advisory panels recommended last week that advisory labels for the drugs, including Actonel and Boniva, include stronger cautionary language. The FDA usually follows such recommendations, but not always, comments the New York Times in its article on the issue.
FDA review process for medical devices, unsatisfactory
The National Academy of Sciences says in an FDA-commissioned report that thousands of medical devices are allowed to go on the market without proper testing for safety. The FDA disputes the finding, reports the Los Angeles Times.
Mobile healthcare apps may be regulated
The FDA is concerned that some mobile healthcare apps may cause harm if/when they don’t work as intended.
Costly cancer drugs may or may not be covered by insurance
Neither the Food and Drug Administration, which decides which drugs can be marketed, nor Medicare, which decides which treatments to cover, considers costs, reports The New York Times.
Insurance companies may stop covering costs of Avastin, a treatment for breast cancer
A Food and Drug Administration panel’s decision this week to reject the drug Avastin for treatment for breast cancer could mean insurance companies would stop covering its costs for patients who depended on it, reports The Philadelphia Inquirer.
Silicone breast implants still safe, says the FDA
The FDA says research in the last five years has shown that silicone breast implants have ‘reasonable assurance of safety and effectiveness.’ The agency was criticized in 2006 for approving the controversial implants after they’d been off the market for 14 years, reports the Los Angeles Times.
Gout drug rejected by FDA
The FDA stuggles with approving a gout drug that had higher serious infection rates during clinical studies.