FDA watches Meridia reports after deaths in Italy

Medical Marketing and Media, May 2002 by Dickinson, James G

The FDA said in March that it is monitoring Abbott Laboratories' European adverse event reports involving the use of weight-loss drug Meridia (sibutramine), which is called Reductil overseas, following temporary marketing suspension ordered by the Italian Health Ministry, reportedly because two patients died after taking the medication.

In addition, Italian regulatory officials said that since the drug was approved a year ago, at least 50 complaints related to sibutramine's side effects have been reported. Apparently the two women who died while taking sibutramine had other serious medical conditions and were taking other medications. "The deaths were related to cardiovascular-related causes," an FDA spokeswoman said.