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drug_recall celebrexA Celebrex withdrawal has not been announced by the makers of this drug, though some experts feel that Pfizer will eventually be encouraged or forced to take their top selling pain killer off the market. Many consumer advocacy groups and other organizations feel that a Celebrex withdrawal is the only way to protect consumers from the dangerous side effects associated with Celebrex use.
Celebrex is a non-steroidal anti-inflammatory drug (NSAID) approved in 1999 to treat the pain associated with osteoarthritis, rheumatoid arthritis, primary dysmenorrhea, and other chronic pain conditions. For years, Celebrex has been one of the ten most popular drugs prescribed in the United States, generating more than two billion dollars in sales revenue each year.
Anticipation of a possible Celebrex withdrawal first began when Vioxx was pulled from the shelves in late September 2004. Vioxx is also an NSAID that is similar to Celebrex in form and function. Vioxx was recalled by Merck after internal clinical research revealed that patients taking Vioxx for eighteen months were two times more likely to suffer a heart attack or stroke than the trial participants in the placebo group. This prompted widespread concern about the cardiovascular safety of all COX-2 selective NSAIDs.
On December 17, 2004, Pfizer announced the details of a clinical trial conducted by the National Cancer Institute designed to test the effectiveness of Celebrex in preventing cancer. This study was suspended after preliminary findings showed that participants who were taking Celebrex were at a much greater risk of suffering cardiovascular problems than those in the placebo group. Participants taking 400 milligrams of Celebrex were 2.5 times more likely, and those taking 800 mg 3.4 times more likely, to have a heart attack or stroke than other patient groups.
Despite these findings, Pfizer made no indication that they planned to issue a Celebrex withdrawal. In the absence of a Celebrex withdrawal, the FDA has urged doctors to prescribe alternative treatments to new patients and some experts urge current patients to stop taking Celebrex. The FDA also requested that all mass media advertisement of Celebrex cease until further investigation of Celebrex cardiovascular risks produces conclusive evidence. The National Institutes of Health has also ordered the review of forty agency-supported Celebrex clinical trials.
The FDA plans to hold a three day hearing in February 2005 to discuss the risks and benefits of all COX-2 selective NSAIDs. Depending on the outcome of this hearing, the FDA may recommend a Celebrex withdrawal. Class action lawsuits are already being filed against Pfizer for failing to exercise reasonable care when marketing a drug with the potential to cause severe and life threatening side effects. With or without a Celebrex withdrawal, legal experts expect many more Celebrex lawsuits to be filed on behalf of Celebrex users and those who have suffered serious injuries because of this drug.
After COX-2 painkillers – Vioxx, Celebrex and Bextra- came under scrutiny when cardiovascular risks were associated to the drugs some drugmakers saw this as an opportunity to try to capitalize on the events.
Vioxx went off the market in Se...
Merck & Co. and Pfizer Inc. have been criticized for their aggressive marketing campaigns for its COX-2 drugs, putting scrutiny on pharmaceutical advertising as a whole. Between December 2003 and November 2004, pharmaceutical ad spending increased 30...
A three-day FDA Advisory Committee meeting has wrapped, but the COX-2 drugs controversy is still not resolved. Although the panel of government medical experts advised keeping the drugs, including Pfizer Inc.’s Celebrex and Bextra, on the market, new...