FDA Sent Warning Letter To Abbott In 2002 About Reporting Meridia Deaths

Abbott Failed To Report Meridia Deaths As Required By Federal Law

Abbott Laboratories, the maker of the diet drug Meridia (sibutramine), violated federal regulations by failing to properly report the deaths of patients taking Meridia to the FDA.

In a July 19, 2002 letter to Abbott, the FDA said that information about seven deaths associated with Meridia was not reported properly to the agency, that one death was not reported to the FDA at all, and that Abbott's reports on three other Meridia deaths were incompletely reported.

The FDA's 2002 letter said Abbott violated rules to provide the agency with data on serious adverse events involving Meridia within 15 days of receiving the information. The FDA warning letter followed reviews earlier in the year of Abbott's post marketing adverse drug experience reporting operations.

An FDA spokeswoman said drug companies must report adverse reactions because those reports often reveal side effects that don't show up in clinical trials. Once a prescription drug is on the market, millions of people use it and rarer side effects come to light. Side effect reports allow the FDA to modify warning labels on drugs and sometimes pull a drug from the market.

The FDA approved Meridia as a prescription drug treatment for obesity in 1997, and the Abbott diet drug has always been known to pose heart and stroke risks. Reductil, as Meridia is called in Europe, was removed from some European markets in March 2002 after reports in Italy associating it with heart attacks. In June 2002, European authorities concluded that Meridia/Reductil could return to the European market.

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