Did anybody see this report about Celebrex? It will be interesting to see what impact it will have on Pennsaid approval.
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Tuesday April 20, 2:17 pm Eastern Time
Celebrex linked to 10 deaths, newspaper says
WASHINGTON, April 20 (Reuters) - The first in a new class of super-aspirin to hit the market, Celebrex, has been linked to 10 deaths and 11 cases of gastrointestinal hemorrhage, the Wall Street Journal reported on Tuesday.
The hot-selling drug, made by Monsanto subsidiary G.D. Searle & Co.,(MTC - news), is one of a new class of painkillers called COX-2 inhibitors. They were designed to battle pain and inflammation without the side-effects of aspirin and related drugs such as ibuprofen, which can cause internal bleeding.
But according to the newspaper, 10 deaths, five of them associated with ulcers and stomach or intestinal bleeding, have been reported in people who took the drug, which has been on the market for three months.
Another 11 cases of stomach or intestinal bleeding have also been reported in the drug, approved for the treatment of both osteoarthritis and rheumatoid arthritis.
The Food and Drug Administration (FDA) keeps tabs on as many adverse reactions as it can. Just because a death has been reported in a person taking a drug does not necessarily mean the drug caused that death.
Neither officials at the FDA nor at Monsanto were immediately available for comment.
Total weekly prescriptions for Celebrex rose to 330,518 for the week ended April 9, according to NDC Health Information Services. More than 2.7 million prescriptions have been written for the drug since it hit the U.S. market in January.
Meanwhile on Tuesday, an FDA advisory panel was reviewing the first potential U.S. competitor to Celebrex, Merck and Co. Inc.'s (MRK - news) Vioxx.
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