On January 9, 2002, Dr. Darlene Jody, Vice President of Medical Marketing for Bristol-Myers Squibb, issued a manufacturer's "Important Drug Warning Including Black Box Information." The Important Drug Warning advises healthcare practitioners that "cases of life-threatening hepatic failure have been reported in patients treated with SERZONE." The manufacturer's Warning indicates that numerous persons have or will suffer liver failure, death or transplantation. The manufacturer's Warning also indicates that the current estimate of the rate of liver failure associated with Serzone use is "about 3-4 times the estimated background rate of liver failure." A new Warning is being added to the Serzone prescribing information, advising that "patients should be advised to be alert for signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur." According to Warnings, Serzone should be promptly discontinued if signs or symptoms suggest liver failure.

Vioxx belongs to a class of drugs known as COX-2 inhibitors. When the drugs were introduced a few years ago, COX-2 inhibitors were thought to be safer and more effective than other drugs such as Aspirin and Ibuprofen. However, several studies have questioned the cardiovascular safety of Vioxx. Studies indicate that people taking Vioxx have four times the risk of a heart attack.

In May 2002, the U.S. Food and Drug Administration (FDA) published a Talk Paper about new label warnings for the popular arthritis and pain drug know as Vioxx (rofecoxib). The new label warnings are based on the results of the Vioxx Gastrointestinal Outcomes Research (VIGOR). According to the FDA, recent studies demonstrate that Vioxx is associated with a higher rate of serious cardiovascular thromboembolic adverse events (such as heart attacks, angina pectoris, and peripheral vascular events). Based on the recent study, the FDA agreed with the Arthritis Advisory Committee recommendations February 8, 2001 that the label for Vioxx include gastrointestinal and cardiovascular warning information. Serious side effects attributed to Vioxx are heart attacks, seizures, strokes, or liver/kidney problems.  http://www.recalleddrugs.com