Pharmaceutical giant Pfizer has been asked to withdraw anti-inflammatory drug Bextra from the United States market
In December 2004, the United States Food and Drug Administration announced a series of revisions made to the new boxed warning in the labels of non-steroidal anti-inflammatory class of drugs, known as NSAID’s, including COX-2 non-steroidal anti-inflammatory prescription drug, Bextra. 1 There have been several serious risks associated with taking the drug. Then in April 2005, the FDA advised Pfizer to voluntarily withdraw, anti-inflammatory prescription drug, Bextra, from the market because the risks clearly outweighed the benefits. 2
Bextra (Valdecoxib) has been prescribed to patients for pain relief, tenderness, inflammation, and stiffness caused from certain excruciatingly painful diseases such as osteoarthritis, arthritis, rheumatoid arthritis, and to treat severely painful menstrual cycles. 3
The less severe side effects Bextra cause are: stomach pain, diarrhea, heartburn, back pain, headache, chest pain, black and tarry stool, bloody vomit, unexpected weight gain, upset stomach, extreme tiredness and fatigue, dizziness, headaches, hives, itching, swelling of the face, throat, tongue, eyes, lips, arms, hands, feet, and/or ankles, fluid retention, liver problems, lack of energy, indigestion, upper respiratory infection, difficulty breathing and /or swallowing, sinusitis, amongst others. 4
The serious side effects are: Steven Johnson Syndrome and toxic epidermal necrolysis. 5 Steven Johnson Syndrome (SJS) is a severe disorder caused by mucous membranes, which causes high fevers, swelling and blisters around the mouth, nose, eyes, and the digestive tract, amongst other places. 6 There is also a less mild form of SJS, which is known as Erythema Multiforme, which causes lesions on the arms, hands, and lower part of the body and the inside of the mouth. 7
Toxic epidermal necrolysis is a rare condition that surfaces on the outer layer of skin. The outermost skin sheds off because of blistering and peeling. Eyes may become red and irritated. 8
There are many cardiovascular risks associated with taking Bextra such as thromboembolic problems such as myocardial infarction (heart attack), cerebrovascular accident (stroke), deep vein thrombosis (blood clots in the leg), and pulmonary embolism (blood clot in the lung). 9
Have you or a loved on taken Bextra and experienced any of the above side effects? Contact us.
1 United States Food and Drug Administration. “FDA Talk Paper: Bextra Label Updated with Boxed Warning Concerning Severe Skin Reactions and Warning Regarding Cardiovascular Risk.” (2004). Rockville, MD. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01331.html (accessed October 12, 2006).
2 U.S. Department of Health and Human Services National Institutes of Health. Medline Plus Valdecoxib. Bethesda, MD.
http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a602011.html (accessed October 12, 2006).
3 U.S. Department of Health and Human Services National Institutes of Health. Medline Plus Valdecoxib. Bethesda, MD.
http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a602011.html (accessed October 12, 2006).
4 U.S. Department of Health and Human Services National Institutes of Health. Medline Plus Valdecoxib. Bethesda, MD.
http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a602011.html (accessed October 12, 2006).
5 United States Food and Drug Administration. “FDA Talk Paper: Bextra Label Updated with Boxed Warning Concerning Severe Skin Reactions and Warning Regarding Cardiovascular Risk.” (2004). Rockville, MD. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01331.html (accessed October 12, 2006).
6 United States Food and Drug Administration. “FDA Talk Paper: Bextra Label Updated with Boxed Warning Concerning Severe Skin Reactions and Warning Regarding Cardiovascular Risk.” (2004). Rockville, MD. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01331.html (accessed October 12, 2006).
7 U.S. Department of Health and Human Services National Institutes of Health. Medline Plus Erythema multiforme. Bethesda, MD. http://www.nlm.nih.gov/medlineplus/ency/article/000851.htm (accessed October 12, 2006).
8 U.S. Department of Health and Human Services National Institutes of Health. Medline Plus Erythema multiforme. Bethesda, MD. http://www.nlm.nih.gov/medlineplus/ency/article/000851.htm (accessed October 12, 2006).
9 United States Food and Drug Administration. “FDA Talk Paper: Bextra Label Updated with Boxed Warning Concerning Severe Skin Reactions and Warning Regarding Cardiovascular Risk.” (2004). Rockville, MD. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01331.html (accessed October 12, 2006).