Bextra was manufactured to treat rheumatoid arthritis along with menstrual pain. It is in a class of drugs call Cox-2 Inhibitors, which also includes Vioxx, Celebrex and Naproxen. Bextra was taken off the US market in 2005 because of reports of serious risks including cardiovascular events and rare skin reactions resulting from the use of Bextra.
Pfizer, the manufacturer of Bextra, voluntarily removed the drug after they conducted two different studies. The studies shows that heart bypass surgery patients taking Bextra had a higher risk of heart attack or stroke. Evidence linked the use of Bextra to these events.
Bextra has also been linked to the rare but serious skin disease, Stevens-Johnson Syndrome. SJS is an extreme allergic reaction to chemicals, and is often cause by medications such as Arava, painkillers and sulfa antibiotics. Of the people taking Bextra that contracted SJS, 27 percent of those patients were left with long term eye damage and vision loss, while up to 15 percent of patients died. Painful symptoms of the disease include swelling and lesions of gums, lounge or lips, excessive tearing or stickiness of the eyes, sores in the genital tract that cause painful urination, fever, blistering, cough, skin rash and difficulty breathing.
After these concerns were raised about Bextra and other Cox-2 inhibitors, an FDA advisory committee met in 2007 to determine the fate of these drugs. The committee ultimately voted to keep Bextra on the market. The New York Times reported that 10 of 32 government drug advisors who voted to keep Bextra on the market have consulted for pharmaceutical manufacturers—creating a conflict of interest. If these 10 advisors had not cast a vote, the committee vote would have been 12 to 8 in favor of removing Bextra from the market.
Serious Side Effects include:
- Skin rash
- Difficulty breathing
- Swelling of the lips, tongue or face, or other symptoms of an allergic reaction
- Abdominal pain, tenderness, or discomfort
- Bloody vomit
- Bloody, black, or tarry stools
- Unexplained weight gain
- Swelling or water retention
- Fatigue or lethargy
- Skin rash
- Yellowing of the skin or eyes
- “Flu-like” symptoms
- Unusual bruising or bleeding
Other, less serious side effects may be more likely to occur:
- Nausea or upset stomach