FDA Warnings for Celebrex, Bextra, and Vioxx

March 2005
A Food and Drug Administration (FDA) Advisory Panel has voted to continue to allow doctors to prescribe COX-2 painkillers, a class of drugs that includes Vioxx, Celebrex, and Bextra. The drugs must now be labeled with “black box” warnings. These strong warnings caution patients and doctors about the increased risk of heart attacks and strokes. The FDA decision seeks to address the conflicts that doctors and millions of patients have between balancing the benefits of the drugs versus the health risks.

The FDA Advisory Panel consisting of scientists, doctors and other experts strongly recommended that anyone who has previously had a stroke or who has existing heart conditions should not take the drugs. When COX-2 inhibitors initially won FDA approval they were touted as highly successful in treating severe arthritis pain. The drugs are designed to reduce pain and inflammation without irritating the stomach like other anti-inflammatory drugs often do.

In fall of 2004, Merck withdrew the painkiller Vioxx from the market after a study determined that the drug doubled the risks of heart attack and stroke. After discovering the link between Vioxx and potential cardiovascular problems, an investigation was launched regarding all COX-2 inhibitors, including the still readily prescribed Celebrex and Bextra, along with the over-the-counter pain medication, Aleve.

Merck, the company that manufactures Vioxx, still faces hundreds of lawsuits from patients who have allegedly suffered serious illness as a result of taking the drug. Despite the lawsuits, Merck is considering bringing the drug back to the market.

Mobic, the drug prescribed to many arthritic patients after Vioxx was pulled from the market, might be equally as dangerous, according to an FDA official.