Vioxx and Bextra The common anti-inflammatory drugs (like aspirin, ibuprofen, and naproxen) all act by blocking the action of both the COX-1 and COX-2 enzymes. Blocking the Cox-2 enzyme impedes the production of the prostaglandins that cause the pain and swelling of arthritis inflammation. Their selective action provides the benefits of reducing inflammation without irritating the stomach. While these drugs pose an advantage in comparison to previous anti-inflammatory drugs because their mechanism of action carries nowhere near the risk of stomach ulceration and bleeding, the fact that they can cause cardiovascular risks (a side effect of some of the COX-2 NSAIDs is an increase in the risk of heart attacks and strokes, especially when they are used at higher doses) Celecoxib (Celebrex) The COX-2 inhibitor Celebrex is currently still on the market and is now taking the place of former prescriptions of Bextra and Vioxx. Although widely expected that COX-2 inhibitors will be of great value to people with arthritis and variety of pain conditions, the increased risk of heart attacks and strokes has caused many to seek alternatives to COX-2 inhibitors. However, in April 2005, an FDA alert warned that Celebrex has been linked to an increased risk of serious cardiovascular (CV) events (such as heart attack or stroke) which appears to be a risk shared by all medicines called non-steroidal anti-inflammatory drugs (NSAIDs) (excluding aspirin). The FDA requested that the package insert (labeling) for all NSAIDs, including Celebrex, be revised to include a “boxed” or serious warning to highlight the potential increased risk of CV events, and the well known risk of serious, and potentially life-threatening, stomach bleeding. FDA has also requested COX-2 inhibitor benefits and risks Currently, the only available COX-2 inhibitor NSAID is Celebrex. The FDA concluded that the benefits of Celebrex outweighed the potential risks but in addition to patient warnings with each prescription, encouraged patients and their physicians to discuss these risks when Celebrex is prescribed. The FDA also advised patients to use the lowest effective dose of Celebrex to control their pain and to use it only as long as necessary. In addition, the FDA now requires the addition of more specific information about the risks for stomach irritation and ulcers, skin rashes, and a possible increase in risk for cardiovascular events with prescription and nonprescription forms of traditional or non-selective NSAIDs except aspirin. NSAIDs are contraindicated after coronary artery bypass surgery. Although all NSAIDs have the potential to cause high blood pressure and worsen congestive heart failure, to date, studies have not clearly shown that the traditional NSAIDs cause an increase in heart attacks and strokes that were seen with some of the COX- 2 NSAIDs. More research is needed to understand if some or all of the traditional NSAIDS also increase the risk of these events. People should not take Celebrex if they: ● Have had an allergic-type reaction to sulfa medicines. ● Have had asthma, hives or allergic-type reactions after taking aspirin or other NSAID (nonsteroidal anti- inflammatory drugs) medicines. People also may have aspirin-sensitive asthma, which means aspirin can cause severe narrowing of the airway (bronchospasm) and even death. Since this type of reaction also has occurred after taking NSAIDs, Celebrex should not be given to aspirin- sensitive patients. ● Are pregnant, especially during the last 3 months. Celebrex and other NSAID medicines can cause serious problems such as: ● Stomach ulcers that bleed : The chance of this serious problem increases the longer a person takes Celebrex, but it can also happen suddenly. If it does, the person should stop taking Celebrex and call a health care professional
was sufficient for the FDA to recall COX-2 inhibitors Vioxx and Bextra. Because of these reports, Merck, the company that makes Vioxx, voluntarily took it off the market in September 2004. On April 7, 2005, Vioxx was recalled because of the potential cardiac risks that were found in a recent study of this drug. In the study, patients who regularly took Vioxx for a period of 18 months or longer had an increased risk of cardiac events, such as heart attack and stroke. Pfizer withdrew Bextra from the market at the FDA’s request due to similar cardiovascular risks and reports of serious skin rashes in some people. In addition, the FDA stated that Bextra had no clear advantage over traditional NSAIDs for pain control. that the package insert for all NSAIDs be revised to state that people who have just had heart surgery should not take these medicines. Prior to the recall of Cox-2 painkillers, these drugs were aggressively marketed as being more effective than traditional painkillers and less likely to cause gastrointestinal side effects associated with older NSAIDs like ibuprofen and naproxen. The studies used to develop this marketing pitch have been highly scrutinized since new studies have found evidence to the contrary. Thousands of injured consumers worldwide have filed lawsuits against the makers of these painkillers. In the United States, consumers who allegedly suffered serious Vioxx side effects have filed at least 7,000 lawsuits against Merck. Hundreds more Bextra side effect victims have filed similar lawsuits against Pfizer. right away. Symptoms include a burning stomach pain, black bowel movements that look like tar, or vomit that looks like blood or coffee grounds. ● Liver damage : Some of the warning signs of liver damage are nausea, vomiting, tiredness, loss of appetite, itching, yellow coloring of skin or eyes, “flu-like” symptoms and dark urine. If this happens, a person should stop taking Celebrex and call a health care professional right away. ● Kidney problems : That include sudden kidney failure or worsening of existing kidney problems. ● Fluid retention (holding of water in the body) and swelling : Fluid retention can be a serious problem for people with high blood pressure or heart failure. In addition to the serious side effects listed above, some common, but less serious side effects with Celebrex may include: ● Headache. ● Indigestion. ● Upper respiratory tract infection (a “cold”). ● Diarrhea. ● Sinus inflammation. ● Stomach pain. ● Nausea. NSAID side effects in general include : ● Gastrointestinal: Dyspepsia, heartburn, epigastric distress, and nausea; less frequently, vomiting, anorexia, abdominal pain, GI bleeding, and mucosal lesions. Misoprostol (Cytotec), a synthetic prostaglandin that inhibits gastric acid secretion, may be given to prevent GI intolerance. It prevents gastric ulcers and their associated GI bleeding in people receiving NSAIDs. ● Genitourinary: Fluid retention, reduction in creatinine clearance, and acute tubular necrosis with renal failure. ● Hepatic: Acute reversible hepatotoxicity. ● Cardiovascular: Hypertension and moderate to severe noncardiogenic pulmonary edema.
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Book Code: MGA1224
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