Meridia Recall By Abbott In October 2010 Follows FDA Request To Withdraw Drug From Market

Meridia Had Been Pulled From Market In Europe Earlier Due To Increased Risks Of Heart Attacks And Strokes Greater Than Benefits

In early October 2010 Abbott Laboratories and the FDA announced a voluntary withdraw of the obesity drug Meridia (sibutramine) from the U.S. market because clinical trial data indicated that Meridia was linked to an increased risk of heart attack and stroke.

This October 8, 2010 Bloomberg news report, "Abbott Pulls Diet Pill in U.S. Amid FDA Safety Concerns", provides an overview about how the Meridia recall happened:

Abbott Laboratories agreed to pull its 13-year-old diet pill Meridia off the U.S. market because of heart attack and stroke risks.

The company announced the removal today at the request of the Food and Drug Administration after Meridia was tied to 16 percent more major cardiovascular side effects in a study of 10,000 high-risk patients who were followed for as long as six years. An estimated 100,000 Americans now take Meridia and Abbott no longer promotes the drug in the U.S.

The FDA’s action comes nine months after Meridia was forced off the market in Europe because of safety concerns....

Abbott said today that it would also halt sales of Meridia in Canada and in Australia, where it was marketed as Reductil. Global sales of the drug in the first nine months of this year were $80 million, including $20 million in the U.S.

As indicated by that Bloomberg article, back in January 2010 there was a difference in opinion between the European Medicines Agency (EMA) and the FDA on the Meridia recall issue. The EMA advised doctors and pharmacists to stop prescribing and dispensing European equivalent of Meridia, known as Reductil. At same time, however, while looking at the same study data, the FDA took a far different approach and simply asked Abbott to put a stronger warning on the Meridia label.

For more details about this October 2010 Meridia recall in the U.S., Canada, and Australia:

FDA Drug Safety Communication: FDA Recommends Against the Continued Use of Meridia (sibutramine) (10/8/10)

Abbott Laboratories Voluntarily Withdraws Weight-loss Drug Sibutramine (Meridia®) from the Canadian Market (10/8/10)

Sibutramine (Reductil) - withdrawal in Australia (10/8/10)

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