Bextra Side Effects
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Bextra, also known by its generic name Valdecoxib, is a non-steroidal anti-inflammatory drug (NSAID) that was marketed by Pfizer as a selective COX-2 inhibitor between November 2001 and April 7, 2005. It was one of the drugs that prompted a thorough FDA re-investigation of all NSAIDs, and was promptly withdrawn from the market in 2005 following the investigation.
The FDA found that all NSAIDs have a constellation of similar side effects: gastrointestinal problems, kidney problems, cardiovascular problems, and skin problems. Bextra's side effects were so serious that the FDA concluded that there was more risk than benefit from taking the drug, and they asked Pfizer to recall it. Pfizer complied, although they say that Bextra is a safe and effective medication.
All NSAIDs cause kidney damage if they are used for a long time, or at high doses. Bextra was similar to the rest of the drugs in its class, and therefore may result in kidney damage.
Bextra and the other COX-2 inhibitors were popular because they were supposed to cause fewer gastrointestinal problems than older NSAIDs, but some people still have problems with gastritis when taking them. Some patients even developed ulcers while taking Bextra, leading to further gastrointestinal problems and even surgery.
It has become apparent that people who take NSAIDs are more likely to have heart attacks, strokes, heart rhythm problems, and blood clots. This is especially true for people who already have heart problems, or who have had coronary artery bypass surgery, but can occur in healthy patients as well. However, following the recall, Pfizer planned to do extensive tests to prove that heart attack and stroke were not linked to Bextra usage.
In rare instances, NSAIDs can cause a serious and sometimes fatal skin disease called Stevens-Johnson Syndrome. Mild SJS is sometimes called Erythema Multiforme, and severe SJS is also called Toxic Epidermal Necrolysis. SJS is an allergic-type reaction to some medications, viruses, and environmental stimuli. It begins as a rash, usually on the hands and soles of the feet. The rash can spread to the legs, arms, trunk and face, and the little flat, red macula can get bigger. They tend to enlarge in concentric circles, creating a target-like appearance. They can also develop pustules, blisters, or wheals, and may begin to overlap one another as the reaction worsens. At this stage, it is usually called Erythema Multiforme, and it is accompanied by flu-like symptoms like muscle aches and fever.
If the skin lesions involve the mucous membranes, this is true Stevens-Johnson Syndrome. Mucous membranes line the mouth, throat, eyes, nose, and vagina. The blisters can become huge, fluid-filled bulges. If the bulges burst, they leave open sores that get infected very easily.
If SJS involves more than 30% of the body surface, it is called Toxic Epidermal Necrolysis (TEN). This is very serious and potentially fatal. Huge areas of skin slough off, leaving large wounds. It is excruciatingly painful and disfiguring. Bextra seems to be much more likely to cause SJS than other NSAIDs. Tragically, Pfizer and the FDA knew all of this before the drug was approved; there were over 20 reports in the US, and many more in Europe.
In the nearly four years that Bextra was on the market, many people were injured and contracted deadly rashes and other conditions, from a medication that they thought had been tested and approved. Some developed ulcers, some have permanent kidney damage, some had strokes or heart attacks, and some developed SJS. Still others lost their lives from taking NSAIDs. If you or someone you know took Bextra and had problems because of it, you may need to talk to a lawyer. A lawyer can help you sort out what happened and advise you. You may be able to get some financial compensation to repay you for your medical and other expenses and to make up for the pain and suffering that occurred. Talk to a lawyer today to see if you have a case against Pfizer.