Vioxx Recall

New research shows that Vioxx may cause an increased risk of cardiovascular events such as heart attack and stroke if used long-term. Vioxx (rofecoxib) is a nonsteroidal anti-inflammatory drug (NSAIDs). NSAIDs are a large group of drugs that include over-the counter NSAIDs like aspirin, ibuprofen, and naproxen, as well as the other prescription NSAIDs Celebrex (celecoxib) and Bextra (valdecoxib). This class of drugs is used to reduce pain and inflammation, and may be used for both short-term and long-term relief in people with osteoarthritis and, more commonly, rheumatoid arthritis.

Vioxx, Celebrex, and Bextra are all classified as COX-2 inhibitors. COX-2 inhibitors work by blocking an enzyme known to cause an inflammatory response. COX-2 inhibitors had been approved for short-term use in the treatment of pain, and for longer-term use to treat the signs and symptoms of osteoarthritis and rheumatoid arthritis. Vioxx works by reducing substances that cause inflammation and pain in the body, and is used to treat arthritis and acute pain in adults.

Merck & Co, the manufacturer of Vioxx has voluntarily withdrawn it from the market after the board overseeing a long-term study of the drug recommended that the study be halted. It recommended this action because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among trial patients taking Vioxx compared to patients receiving placebo. Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo.

The Food and Drug Administration (FDA) acknowledged the voluntary withdrawal and issued a Public Health Advisory to inform the public of this action and to advise them to consult with a physician about alternative medications. In addition, the FDA will closely monitor other drugs in this class (NSAIDs) for similar serious cardiovascular side effects. It is already acknowledged that all of the NSAIDs, whether over-the-counter or prescription, have side effects including gastrointestinal bleeding, as well as liver and kidney toxicity.

Recently, an FDA advisory panel, whose recommendations the FDA generally follows, indicated that it believes Vioxx can return to the market, but with strict warnings adhered. It also indicated that the other NSAIDs/COX-2 inhibitors involved in the increased risk of cardiovascular events, Celebrex and Bextra, could stay on the market with the strict warnings as well. It is the opinion of the FDA advisory panel that the FDA should also require strict "black box" warnings on all three Cox-2 drugs to alert patients and doctors to their risks. A black box warning is the most serious warning placed on the labeling of a prescription medication.

This recommendation was based on the experts stating that these drugs should carry strict warnings indicating that they can raise the risk of heart attacks and stroke. At the hearings, these experts also expressed frustration that the companies producing Vioxx, Celebrex, and Bextra have not performed enough studies that clearly address the safety of Cox-2 inhibitors and older pain relievers. Several urged regulators to require more safety studies as a condition for allowing the drugs to stay on the market.

In addition, the committee unanimously recommended that more than 20 older anti-inflammatory drugs also carry precautions of potential heart risks on their labels. It did not specify which drugs should carry the warnings or how strong they should be. Some of the older NSAIDs, including diclofenac and Mobic, are similar chemically to Cox-2 drugs and may have to carry warnings because of limited evidence that they can influence heart attacks.

The FDA originally approved Vioxx in 1999 as a treatment for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain in adults and severely painful menstrual cycles. The FDA later approved Vioxx to treat rheumatoid arthritis and its symptoms.

*Vioxx, Celebrex, and Bextra are the trademarks of their respective owners.

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