Two News Reports Make Me Go "Humm?" Posted
by Rob Schneider at 04/21/06 03:34 PM
Sometimes you just have to wonder what drug companies and doctors are thinking. Last year, the FDA issued the following alert:
FDA Alert: 4/7/2005:
Celebrex has been associated with an increased risk of serious adverse cardiovascular (CV) events in a long-term placebo controlled trial. Based on the currently available data, FDA has concluded that an increased risk of serious adverse CV events appears to be a class effect of non-steroidal anti-inflammatory drugs (NSAIDs) (excluding aspirin). FDA has requested that the package insert for all NSAIDs, including Celebrex, be revised to include a boxed warning to highlight the potential increased risk of CV events and the well described risk of serious, and potentially life-threatening, gastrointestinal bleeding. FDA has also requested that the package insert for all NSAIDs be revised to include a contraindication for use in patients immediately post-operative from coronary artery bypass (CABG) surgery.
Okay, so Celebrex wasn't withdrawn from the market like Vioxx was. Nevertheless, concerns about COX-2 drugs have been all over the news with Merck, Vioxx' maker, hit with a number of lawsuits alleging serious problems and deaths resulting from taking the drug -- that happens to be in the same therapeutic class as Celebrex.
So this week I was interested to see that Merck had lost another case over Vioxx. From the NY Times today:
A state jury found Merck & Co. liable Friday for the death of a 71-year-old man who had a fatal heart attack within a month of taking its since-withdrawn painkiller Vioxx and ordered the company to pay $32 million. Merck said it would appeal.
And, this week, I see Pfizer announces that sales of Celebrex had increased 19 percent.
Humm.
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