Word: avandia
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...MEDICINE 43% Increased risk of heart attack for people taking the GlaxoSmithKline diabetes drug Avandia, according to a new study that prompted a safety alert from the U.S. Food and Drug Administration. The company disputes the analysis 6 million Number of people worldwide who have taken Avandia since it came on the market eight years...
...Increased risk of heart attack faced by people who take the diabetes drug Avandia, according to a New England Journal of Medicine study that prompted the Food and Drug Administration to issue a safety alert...
...GlaxoSmithKline shares took an immediate hit from the release of Nissen's study, falling 7.85% on Monday, with more than 11 million shares - nine times the usual trading volume - changing hands. Investors, not surprisingly, were spooked by the doubts raised about Avandia, which accounted for $3.2 billion in sales last year for GSK. The company went on the offensive almost immediately, releasing a statement criticizing Nissen's research methods. "GSK strongly disagrees with the conclusions reached in the NEJM article, which are based on incomplete evidence and a methodology that the author admits has significant limitations," read the statement. Mary...
...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...
...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...