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Since Meridia's introduction to the U.S. market in March 1998 through September 2001, Meridia has been associated with 29 deaths in the U.S. A total of 397 serious adverse reactions were reported to the FDA, resulting in 152 patients being hospitalized. Of the 29 U.S. patients that died, 19 of the deaths were from cardiovascular causes such as heart attacks. 10 of the cardiac deaths occurred with people who were 50 or younger, including 3 women under the age of 30. There were also 143 patients in whom an arrhythmia was reported.
Prior to its approval in 1997, an FDA advisory committee voted five to four that the benefits of Meridia did not outweigh the risks. The FDA medical officer who reviewed the drug wrote that Meridia "has an unsatisfactory risk-benefit ratio and therefore this Reviewer recommends non-approval of the original submission." The concern of both the advisory committee and the FDA medical officer was based on evidence that Meridia significantly increases blood pressure and heart rate in patients.