Merck could have warned that its popular painkiller Vioxx might increase the risk of heart attacks as soon as the first evidence showed up, rather than waiting two years for federal approval, a former Food and Drug Administration official testified in the first Vioxx federal retrial in The Big Easy on Friday.
Richard Kapit said there was plenty of time to alert the public before Richard "Dickie" Irvin began taking Vioxx, which his widow claims caused his fatal heart attack after a month on the drug in 2001. Merck says it alerted the FDA in 2000 that a study showed heart attacks occurred five times as often in patients taking Vioxx as those on another drug, called naproxen.
The agency didn't approve the label change until April 2002. The company pulled the drug from the market in September 2004, after another study showed that it could double the risk of heart attacks.
Kapit, who worked for the FDA for 16 years, mostly as a drug application reviewer analyzing adverse effects, said companies are allowed to change a drug label as soon as it applies for permission to add or strengthen a warning, precaution, or other information about a serious side effect.
So - why the delay from a company who claims to "put patients first"?
Source: Janet McConnaughey, AP
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