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Pain Medications (cont.)

Cox-2 Inhibitors

  • Long-term use of NSAIDs can cause bleeding in the stomach. In response to this, the drug industry has produced a class of NSAIDs, the COX-2 Inhibitor.
  • Presently, only celecoxib (Celebrex) remains on the market. Valdecoxib (Bextra) and rofecoxib (Vioxx) were voluntarily withdrawn from the market because of an increased risk of heart attack, stroke, and severe skin toxicity (see below).
  • Because these medications have been on the market for only a short time, the long-term side effects are just beginning to be understood. These medications have not been proven to be stronger than ibuprofen, acetaminophen, or naproxen. It is also unclear whether these medications cause less significant stomach problems.
  • People older than 75 years are at more risk of significant stomach problems, such as ulcers, from NSAIDs, especially if they have had previous ulcers. Elderly individuals also typically have higher risk factors for heart attack and stroke.
  • Alert: On September 30, 2004, Merck & Co, Inc, announced a voluntary withdrawal of the COX-2 inhibitor, rofecoxib (Vioxx), from the US and worldwide market because of its association with an increased rate of cardiovascular events (including heart attacks and strokes) compared to that of placebo. A major US Food and Drug Administration (FDA) study of rofecoxib found an apparent 3-fold increase in the risk of sudden cardiac death or heart attack among patients who had taken higher doses of the drug compared to the risk of patients who had not recently received similar medication. The report showed that even patients taking the standard starting dose of 12.5 mg or 25 mg of rofecoxib had a 50% greater chance of heart attack or sudden cardiac death than patients on any dose of celecoxib (Celebrex). The large-scale study was conducted after analyzing the medical records of 1.4 million people insured by Kaiser Permanente in Oakland, Calif, between 1999-2001.
  • Alert: On April 7, 2005, valdecoxib (Bextra, by Pfizer, Inc) was voluntarily withdrawn from the US market, pending further discussion with the FDA. The association of valdecoxib with potentially life-threatening risks, including myocardial infarction, stroke, and serious skin reactions, initiated an investigation to determine whether the benefits of the drug outweighed the risks. The serious skin reactions are most likely to occur in the first two weeks of treatment, but they can occur at any time during therapy. Other COX-2 inhibitors and traditional NSAIDs (for example, naproxen [Aleve, Naprosyn], ibuprofen [Motrin]) also have a risk for these rare, serious skin reactions, but the reported rate of the reaction appears to be greater for valdecoxib. Data regarding risks in individuals who take valdecoxib following heart bypass surgery showed an increased risk of heart attack, stroke, deep vein thrombosis (blood clots in the leg), and pulmonary embolism (blood clots in the lungs).
  • Celecoxib (Celebrex) remains on the market and appears to have the same cardiac risk profile as does ibuprofen.
Besides COX-2 inhibitors, other options exist to protect the stomach from ulcers and bleeding associated with NSAIDs. The additional use of misoprostol (Cytotec) or a proton pump inhibitor, such as omeprazole (Prilosec), lansoprazole (Prevacid), or esomeprazole (Nexium), with an older NSAID may decrease ulcer formation and bleeding.
Medically Reviewed by a Doctor on 5/7/2013

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