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FDA COX-2 safety panel; industry-wide scrutiny
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The FDA forced Pfizer to withdraw Bextra due to cardiovascular and skin risks, requiring strong black-box warnings on all NSAIDs including Celebrex. The move leaves only Celebrex in the U.S. COX-2 market, impacting Pfizer's revenue and prompting broader scrutiny of post-market drug safety, while analysts expect continued debate over drug risk hierarchies and regulatory oversight.
Guidant Corp. recalled nearly 50,000 cardiac defibrillators due to a short-circuit flaw, linked to 45 malfunctions and two deaths, prompting FDA support and patient monitoring. The affected models include Prizm and Contak devices, with some eligible for reprogramming or replacement. The recall intensifies scrutiny on Guidant ahead of its $25.4 billion acquisition by Johnson & Johnson, potentially impacting regulatory approval and investor confidence.