The U.S. Food and Drug Administration (FDA) recently approved the first generic version of Celebrex (celecoxib), a potent and potentially lethal pain-killer. Celebrex was the lone survivor of the “big three” pain drugs (including Vioxx and Bextra) in the cox-2-inhibitor family of medicines prescribed for pain conditions like arthritis. The health dangers of Vioxx and Bextra resulted in their removal from the market in the mid-2000s but it remains a mystery why Celebrex escaped a similar fate.
Perhaps the willingness of its maker, pharmaceutical giant Pfizer, to openly declare, “Important Information: Celebrex may increase the chance of a heart attack or stroke that can lead to death” as part of its advertising helped to keep it in the marketplace when its competition disappeared. But how could the company, medical doctors, the government and even patients continue to support this product in this face of overwhelming evidence of its danger?
Now, the FDA has opened the door for Teva Pharmaceutical Industries to manufacture and sell celecoxib—the active ingredient also found in Celebrex—in strengths ranging between 50 milligrams and 400 milligrams. A second company, Mylan Pharmaceuticals Inc., received approval to market 50 mg celecoxib capsules. In 2008, a study found that people who take 400 milligrams of Celebrex twice a day have three times the risk of having heart attacks, other heart problems, strokes, or cardiovascular disease death, compared with people who don’t take the drug. People who take 200 milligrams twice daily have double the risk. The research was funded by the National Cancer Institute and involved an analysis of six studies with Celebrex and a placebo in nearly 8,000 patients being treated for conditions other than arthritis.
What is the upside for patients when the FDA requires a death warning on a medicine? Why would the government approve a generic version of this drug when it acknowledges the numerous cardiovascular, gastrointestinal and other health risks, many of which are far worse than the pain the drug-users are trying to suppress? These questions are best directed to the FDA.
Pain is a horrible experience. It can rob you of the joy in your life when it is chronic. Fortunately, many types of pain can be managed and greatly reduced with lifestyle and diet changes. Mother Nature has a complete arsenal of pain-killing food and herbs, many of which have been scientifically proven to reduce pain better than pharmaceuticals. Plus, they taste great and have no life-threatening side effects.
For those of you still tempted to take this drug or other cox-2 inhibitors and non-steroidal anti-inflammatory drug (NSAIDS) pain-killers: be careful, they can kill more than pain.
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