Bextra And Cardiovascular Risks
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Bextra (valdecoxib), manufactured by Pfizer, is used to reduce pain that is associated with osteoarthritis, rheumatoid arthritis, menstruation, and other medical conditions. The main ingredient was a steroid anti-inflammatory, which works a lot like Motrin or Aleve, but in a stronger dose. With arthritis, Bextra was marketed to relieve pain in the joints for better mobility. Unlike Motrin, which is taken as needed, Bextra was prescribed as a daily dose to be taken daily. Bextra is among the COX-2 inhibitors, like Vioxx. As with most drugs, side effects are inevitable, which is why the FDA (the Food and Drug Administration) regulates the prescription drug market. Typically, drug manufacturers must produce clinical drug studies to prove its effectiveness, which then must be regulated by the FDA.
Patients taking the drug daily were found to have a two-and-a-half fold increase in the risk of having a major cardiovascular event. New studies were showing the increased risks of heart attacks and strokes, which eventually led to its 2005 withdrawal from the market, as requested by the FDA. The FDA requested this removal based on the lack of data on cardiovascular safety from long-term Bextra use, as well as the increased risk of adverse cardiovascular, even for heart patients coming out of coronary artery bypass graft (CABG) surgery. After a clinical study done by Pfizer, where CABG patients were studied for the effectiveness to relieve pain after surgery, it was found that the patients were twice as likely to suffer either a heart attack or heart failure. Another study done at the University of Pennsylvannia even stated that the effects of Bextra are even more dangerous than was found in Vioxx (another COX-2 drug previously taken off the market). This study believed that the entire class of COX-2 drugs were more harmful than helpful.
Another concern for Bextra users was the severe skin reaction that was possible. These skin reactions could sometimes be fatal. The symptoms included any kind of skin rash, swelling of the face, lips, and tongue. Other symptoms included difficulty breathing, itching, breaking out in hives, or any other skin condition noted. Patients were urged to call their doctors immediately if any of these symptoms started to appear. Other concerns over patients taking Bextra were those who had symptoms such as heartburn, unusual stomach pain or discomfort, nausea, vomiting blood, black tarry stools, yellowing of the skin and eyes, water retention, bruising or bleeding, and flu-like symptoms. Patients were also urged to call their doctors if these symptoms appeared. Those who had cardiovascular risks were advised not to take this drug, especially for pain after heart surgery.
Since Bextra left a lot of questions unanswered regarding cardiovascular risks, it was in the best interest of consumers to take it off the market until further research could be done. This decision also left consumers wondering what their options were, and what to expect if they had already been using it for quite some time. First, talk to your doctor and find out if there is an alternative medicine that you can take. In addition, it may be a good idea to be well-educated on the side effects, and document any that you believe you suffer from. Also contact a lawyer to find out what legal rights you have.
Having a serious illness is stressful enough, and dealing with a lawsuit may be the last adventure that you want to take on. However, just remember that you were prescribed Bextra with the faith that you were supposed live with less pain. Consequently, you were put in grave danger. If you have experienced any side effects from taking Bextra, be sure to mention this while talking to your lawyer. They can advise you on what to do next. Anytime a drug is pulled off the market, consumers need lawyers to advise them and fight for them if necessary. Sometimes drugs can do a lot of damage before they are pulled. In fact, it usually takes substantial evidence to pull drugs from the market.