Bextra Recall
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In 2004 and 2005, NSAIDs (non-steroidal anti-inflammatory drugs) were under close scrutiny by the Food and Drug Administration (FDA), the media, and the American public. These drugs had been available for several decades and were originally deemed to provide a real advancement in the treatment of arthritis. Prior to the use of NSAIDs, treatment options were limited to: Aspirin, which causes bleeding and stomach ulcers, especially when taken for a long period of time; acetaminophen, which is not an anti-inflammatory medication, but does help relieve pain; potent pain medications such as narcotics; and steroids, which can have frequent, serious and scary side effects.
No medication is completely free of side effects or adverse reactions, and NSAIDs are no exception. Bextra was found to have caused stomach problems, but far milder than aspirin, and also led to kidney damage when patients took high doses over a long period of time. In very rare instances, NSAIDs caused a rare but serious skin disease known Stevens-Johnson Syndrome.
In 1999, Vioxx was introduced to the public by Merck Pharmaceutical Company. It was a new class of NSAID, a COX-2 inhibitor. All NSAIDs work by inhibiting the COX enzyme, an enzyme that is necessary for inflammation. Researchers had discovered that there are two types of COX enzymes, one that is part of the inflammatory process (COX-2) and one that works in the stomach and helps protect the stomach lining (COX-1). This new class of NSAID, it was hoped, would cause less of the stomach problems, like gastritis and ulcers, which people endured with aspirin and older NSAIDs. Before long, two other COX-2 inhibitors joined Vioxx on the market: Bextra and Celebrex, both manufactured by Pfizer.
It soon became apparent that the new drugs had even more side effects and adverse reactions than the older NSAIDs. In 2004, Merck voluntarily withdrew Vioxx from the market worldwide. On April 7, 2005, the FDA asked Pfizer to voluntarily withdraw Bextra, and required new labeling and warnings for all NSAIDs, including those sold over the counter. Here's a summary of their recommendations:
* Over-the-counter NSAIDs (ibuprofen, naproxen and others) must be labeled to inform people that taking these medicines carries a risk of serious adverse effects for people who have had coronary artery bypass surgery, coronary artery disease, cerebrovascular disease, or ulcers. They must also carry information about the risk of potentially serious skin problems.
* All prescription NSAIDs must carry a black box warning that people who take them may have an increased risk of heart problems and ulcers. The label states that they are not to be used if a patient has recently had coronary bypass graft surgery. The patient is also to be given a medication guide with their prescription that describes potential problems and proper use of the medication.
* Pfizer was asked to withdraw Bextra from the market because the FDA determined that its risk-to-benefit profile was unfavorable. It was no better than other medications already available, and also carried a higher risk for heart problems and significantly more skin problems.
* The FDA said Merck had voluntarily withdrawn Vioxx, but that they would have to re-examine their data before it could be reintroduced.
* The benefits of Celebrex outweighed the risks, and it could continue to be sold. The FDA required extensive labeling, though, and insisted that patients be given a medication guide. Pfizer is also required to do a long-term study to evaluate the risks of Celebrex.
Obviously, it takes a lawyer to sort all of these issues out. If you've taken these drugs, including Bextra, and you had side effects or adverse reactions, you should talk to a lawyer. Several lawsuits have been brought against the drug companies by people who were harmed by the drugs. These drug companies made billions of dollars by selling drugs they knew were dangerous, and there will not be any criminal charges filed against them. The only way they will pay for what they've done is through lawsuits, which will benefit the people they've hurt. If you're one of those people, it may be time to call a lawyer.
