Word: fda
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Dates: during 2000-2009
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Finally, scientists have invented a contraceptive pill that does away with a woman’s period entirely. Lybrel, the new pill, can be taken continuously without the monthly bleed that most pills require and, since its approval last month by the Food and Drug Administration (FDA), it now seems possible to release women everywhere from their wretched biological “curse.” In short, welcome liberation; goodbye Tampax...
...when it comes to a woman buying a regular contraceptive pill, the FDA has put its foot down: Get thee back to the maternity ward, woman! The regular contraceptive pill is not, and has never been, available over-the-counter (OTC) in any American pharmacy. In order to get hold of “The Pill,” a woman must first see a doctor, who will politely grill her on her sexual history, suggest strongly that she have a pair of tongs stuck up her vagina for a pap smear, and send her on her merry way with...
...results of Nissen's research were troubling enough that the Journal, in an editorial accompanying his article, concluded that "the rationale for prescribing rosiglitazone at this time is unclear." The cardiovascular risks simply outweigh any benefit the drug appears to give in treating diabetes, the editorial says, and the FDA should now take regulatory action. With more than 1.5 million new cases of Type 2 diabetes each year in the U.S. and Avandia a mainstay in their treatment, 60 million prescriptions have been written since the drug was introduced...
...FDA, however, moved quickly to respond to what it called "a potential safety issue related to Avandia," issuing a safety alert on the drug just hours after Nissen's study was made public. While the agency pointed out that other studies of the drug have reached different conclusions, it nonetheless will take up the issue of the cardiovascular risk of Avandia and similar drugs with an advisory committee "as soon as one can be convened." Earlier data about Avandia prompted the FDA to strengthen the drug's warning label last year. The FDA also disclosed that GSK recently provided...
...submitted that information to the FDA last fall, Rhyne says, but so far the agency has not recommended any action based on it. "We've shared what we have, and we've done so in a timely and appropriate way," she says. That may prove to be a key issue as the FDA, scientists, investors and patients weigh their next move on Avandia. Merck's undoing, after all, wasn't just the data; it was concerns over the disclosure of it. Says Nissen: "There will be a lot of questions about who knew what, when...