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drug_recall celebrexConsumer rights groups and medical experts across the nation have argued for the inclusion of a Celebrex black box warning on all product information for this medication, the only COX-2 pain killer remaining on the market. The Celebrex black box sought was to include strong warnings, the strongest the FDA can order short of a drug recall, about the serious risks of cardiovascular side effects associated with Celebrex.
In 2004 the results of a Pfizer-sponsored clinical trial indicated that use of Celebrex at 400 milligrams per day could more than double a patient’s risk of suffering a heart attack or stroke. The study also found that patients taking 800 milligrams more than tripled their risk of suffering a life-threatening cardiovascular event. Similar findings were also discovered in Bextra and Vioxx studies, and these drugs were subsequently removed from the drug market.
Bextra, Vioxx, and Celebrex are all similar COX-2 non-steroidal anti-inflammatory drugs used to treat the chronic pain associated with rheumatoid and osteoarthritis and other pain conditions. Vioxx was first to be pulled off the market in September 2004 after studies found that patients taking this drug for 18 months doubled their risk of heart attack and stroke. Bextra was recalled in 2005 for unacceptable cardiovascular risks and serious skin conditions.
Though Celebrex has been linked to similar risks, the FDA has allowed this COX-2 painkiller to remain on the market, in part because of its additional benefits in the treatment of colon polyps (FAP). Instead of a recall, the FDA ordered the addition of a Celebrex black box warning to all product labeling to inform consumers about serious cardiovascular risks. The Celebrex black box is the most potent warning that the FDA can order and requires a black box detailing the risks in bold type on all written information and a verbal explanation of the showcased risks on all Celebrex commercials.
In August 2005, the FDA sent out a mixed message by approving Celebrex for a new use while simultaneously issuing a Celebrex black box warning about the serious risks associated with cardiovascular injuries. The FDA approved Celebrex for the treatment of pain associated with ankylosing spondylitis, or arthritis of the spine. The FDA also issued the Celebrex black box, advising of patient risks and providing treatment recommendations.
The Celebrex black box warning recommends that patients be prescribed the lowest dose medication possible to be used for the shortest duration possible. The warning also states that patients should not be given Celebrex for the treatment of pain following heart bypass surgery. The Celebrex black box warns patients of increase cardiovascular and gastrointestinal risks. All NSAIDs, except aspirin, now contain warning similar to the Celebrex black box warning regarding these adverse drug events.
If you would like to learn more about the Celebrex black box or have been injured by this medication, please contact us to speak with a qualified and experienced attorney.
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