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April 7, 2005 - Like Vioxx, the anti-inflammatory painkiller Bextra has been withdrawn from the market. And a warning is being added to Celebrex and other prescription and over-the-counter anti-inflammatory drugs.
Details of the New Announcement
The FDA has concluded that the overall risk of Bextra outweighs the benefit. They have asked Pfizer, the manufacturer, to voluntarily withdraw the drug from the market.
In addition, the FDA is requesting that manufacturers of all prescription anti-inflammatory drugs, including Celebrex, include a boxed warning on their label. The boxed warning will highlight the potential risk of heart disease and stroke and the well-described, serious, and potentially life-threatening stomach ulcer bleeding associated with these drugs.
The FDA is also asking manufacturers of over-the-counter anti-inflammatory drugs to revise their labeling to include more specific information about the potential stomach ulcer, heart, and stroke risks.
The new information will include instructions about which patients should seek the advice of a doctor before using these drugs, stronger reminders about limiting the dose and duration of treatment in accordance with the package instructions unless otherwise advised by a doctor, and a warning about potential skin reactions.
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