Meridia: Market Withdrawal Due to Serious Cardiovascular Event Risk

Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary withdraw of Meridia (sibutramine), an obesity drug, from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.
Meridia was approved November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone. FDA has now requested market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT is part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of the drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared with another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.
Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.
Read the MedWatch safety alert, including links to the FDA Drug Safety Communication, Q&As, and News Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm228830.htm

About The Author

Laura Hack

Laura Hack

Laura Hack is a paralegal with Terrell • Hogan. She has been with the firm since 1996 and has worked primarily for Wayne Hogan. She is an experienced Paralegal with 30+ years of working in the law practice industry. Skilled in Appeals, Civil Trial Litigation Support, Torts, Trial Practice, and Pleadings.