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drug_recall celebrexA Celebrex problem is any side effect from this prescription drug that causes injury to a patient. There have been serious Celebrex problems discovered since this painkiller was first introduced on the US market. Celebrex is a COX-2 selective non-steroidal anti-inflammatory drug (NSAID) that was approved by the FDA in 1999 to treat a number of chronic pain conditions like arthritis and menstrual cramps. Celebrex problem cases began surfacing within the first year of this blockbuster drug’s stay on the market.
The first evidence of a Celebrex problem was first discovered in a clinical trial designed to measure the gastrointestinal effects of Celebrex. Celebrex and all the COX-2 NSAIDs were originally developed to provide powerful pain relief without the gastrointestinal side effects associated with traditional NSAIDs like ibuprofen and naproxen. The CLASS study found that Celebrex did not cause gastrointestinal side effects with the same frequency as some traditional NSAIDs.
The study also produced evidence of a Celebrex problem. The participants in the trial who had taken Celebrex were more likely to suffer heart problems compared to those taking the traditional NSAIDs. This Celebrex problem did not illicit additional investigation of cardiovascular risks, though many experts believe that Pfizer had a responsibility to further evaluate this Celebrex problem.
Concerns about a potential cardiovascular Celebrex problem resurfaced in late 2004 after the recall of a similar drug that September. Vioxx was voluntarily pulled from the shelves by Merck, its maker, after studies found that Vioxx use doubled a patient’s risk of suffering a heart attack or stroke. Pfizer was quick to claim that these cardiovascular side effects were unique to Vioxx and made no indication of a possible Celebrex problem.
In December 2004 Pfizer announced that a serious Celebrex problem had been discovered in a clinical trial. The National Cancer Institute designed a three year study to measure the effectiveness of Celebrex treatment in the prevention of colon polyps. The trial was stopped short after the emergence of a serious Celebrex problem. The study found that participants taking 400 milligrams of Celebrex a day were 2.5 times more likely to suffer a heart attack or stroke than those not taking Celebrex. Participants taking 800 milligrams of Celebrex daily were 3.4 times more likely to suffer an adverse event.
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...