The US and European regulatory authorities have asked Pfizer to withdraw its selective cyclooxygenase 2 (COX2) inhibitor, valdecoxib (Bextra), from the market.
The lowdown. Is this a sign that the FDA is becoming more cautious, after facing pressure over its handling of drug-safety issues? The FDA's decision went against the advisory committee's narrow vote in favour of keeping Bextra on the market — although the committee didn't take into account Bextra's other adverse effect of allergic skin reactions. Unlike the EMEA, the FDA called for black-box warnings of cardiovascular and gastrointestinal risks to appear on all prescription versions of non-steroidal anti-inflammatory drugs, and strong warnings to appear on over-the-counter painkillers, despite no strong evidence for a risk. Ironically, the FDA's decision could be beneficial for Pfizer. Its celecoxib (Celebrex) is now the only selective COX2 inhibitor on the market and so could re-establish a large proportion of its sales, which reached $3.3 billion last year. Celebrex could also pick up a portion of Bextra's revenues, which made $1.29 billion in sales last year.
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