Bextra (Valdecoxib): COX-2 inhibitor On April 7, 2005 the Food and Drug Administration requested that Pfizer suspend sales of Bextra in the United States. As a result, Bextra will no longer be available to patients in the United States. For more information, click to the Bextra homepage. Bextra is a second generation prescription pain medication that is in the COX-2 class of drugs. The active ingredient in Bextra is Valdecoxib, and it works by reducing inflammation, which often is a component of back pain and neck pain. Brand name Bextra Active ingredient Valdecoxib Category NSAID (non-steroidal anti-inflammatory drug) Company Pharmacia/Pfizer FDA approval November 16, 2001 Indications for Bextra Bextra is approved use for signs and symptoms of osteoarthritis in adults, rheumatoid arthritis in adults, and painful menstrual cramps. Bextra is not approved for management of pre-operative or post-operative pain. Contraindications for Bextra People who should not take Bextra include: Patients allergic to valdecoxib or any other ingredients in Bextra Patients allergic to sulfonamide-type drugs or sulfa Persons who have experienced asthma, hives, or allergic reactions after taking aspirins or other NSAIDs Women who are in late pregnancy Patients who have serious coronary artery disease or who have recently had coronary artery bypass graft surgery (CABG) (2) Dosage of Bextra Bextra may be taken as a 10 mg or a 20mg pill. Dosage of Bextra is based on the patient’s medical condition and response to therapy. The FDA has recommended the following dosages for Bextra: For osteoarthritis, oral dosage of 10 mg once daily. For rheumatoid arthritis, oral dosage of 10 mg once daily. For painful menstrual cramps, oral dosage of 20 mg twice daily. Usage of Bextra Bextra may be taken with or without food. If a dose of Bextra is missed, the patient may take it as soon as remembered, unless it is near the time of the next dose, in which case the patient should skip the missed pill and take the next dose at the right time. Bextra should be stored at room temperature and away from light and moisture. Possible side effects and warnings for Bextra As with all NSAIDs, there is a risk of stomach problems. Although this is a very rare side effect with Bextra, it is still a possible side effect, and the risk increases with prolonged use. Bextra and other NSAIDs may cause stomach ulcers that bleed. The risk increases with a longer duration or a higher dosage of Bextra. Patients should stop using Bextra and call their doctor if they experience any of the following symptoms (2): Burning pain in the stomach Dark stools that look like tar or blood in the stools Vomit resembling blood or coffee grounds Bextra and other NSAIDs can lead to liver damage, and warning signs include nausea, vomiting, tiredness, appetite loss, itching, yellow coloring of skin or eyes, flu-like symptoms and dark urine. Patients experiencing any of these symptoms should discontinue use of Bextra immediately and consult their physician (2). Bextra can also cause serious skin reactions that may result in death (e.g. Steven-Johnson Syndrome and toxic epidermal necrolysis). Use of Bextra should be discontinued immediately if the patient develops any of the following symptoms (3): Skin rash Mouth sores Any other signs of an allergic reaction Recent study results for Bextra are inconclusive, but some show an increased risk for cardiovascular problems (e.g. heart attack and stroke) among certain groups of patients. The label for the drug has been changed, warning recent recipients of coronary artery bypass surgery (CABG) to avoid using Bextra. More information is available at New research on COX-2 inhibitors and other NSAIDs. Other rare but serious potential problems from Bextra include serious allergic reactions and kidney problems. Some less serious side effects of Bextra can include indigestion, nausea, stomach pain, upper respiratory tract infection, diarrhea and headache (2).   The most common side effects experienced by patients participating in clinical studies at the time of this article included stomachache, diarrhea, and headache. General precautions for Bextra In light of new concerns regarding potential NSAID side effects, patients currently taking Bextra should talk to their physicians to evaluate their treatment needs and individual risk factors (such as cardiovascular problems). Additional patient information can be found at Safe use of COX-2 inhibitors and other NSAIDs. Patients should never take Bextra or any other medications without first discussing it with their doctor. It is important to discuss any other medications that are being taken (including those taken without a prescription and vitamins or dietary supplements), and to be complete and accurate in providing a medical history to the doctor. Patients who have any reaction to aspirin (such as asthma) or other NSAIDs (such as ibuprofen or naproxen) may be sensitive to Bextra and other COX-2 inhibitors. Daily use of alcohol or excessive alcohol consumption may increase the patient’s risk of serious stomach problems. Extra caution is warranted for elderly patients taking Bextra, as elderly patients may be most susceptible to possible side effects. It is not yet known whether or not Bextra can pass through breast milk and affect infants who are breastfeeding. Important update on Bextra and other NSAIDs Since the September 2004 recall of Vioxx (another popular COX-2 inhibitor) and based on recent study findings, the FDA has issued new guidelines for safe use of COX-2 inhibitors. Patients can find additional information at Understanding COX-2 inhibitor side effects. By: Donald J. Frisco, MD October 7, 2003 (Updated March 23, 2005) References: 2.  U.S. Food and Drug Administration. “Bextra Information.” November 22 2002. http://www.fda.gov/cder/consumerinfo/druginfo/bextra.htm. 3.  U.S. Food and Drug Administration. “Questions and Answers: Strengthened Warnings on Bextra.” December 9, 2004. http://www.fda.gov/cder/drug/infopage/bextra/bextraQA.htm.