News | October 13, 2010

Obesity Drug Withdrawn in U.S. Due to Cardiovascular Complications

October 13, 2010 – The anti-obesity drug sibutramine will be withdrawn from the U.S. market after a study found it had cardiovascular safety risks. Sibutramine (Meridia), made by Abbott, is a prescription medicine used to help overweight or obese people lose weight.

Abbott is voluntarily withdrawing the drug at the request of the U.S. Food and Drug Administration (FDA).

The FDA's request is based primarily on the results of the SCOUT study, a 10,000 patient, six-year study requested by European regulatory authorities to evaluate cardiovascular safety in high-risk patients. The majority of these patients had underlying cardiovascular disease and were not eligible to receive sibutramine under the current labeling.

The SCOUT results are in contrast to the vast body of sibutramine data for the on-label patient population, including 46 controlled clinical trials and more than 6 million patient years of use accumulated over 13 years during which the product has been available. These data fail to confirm the excess cardiovascular risk found in the SCOUT study.

The voluntary withdrawal follows an 11-month process, beginning in November 2009, when Abbott promptly notified the FDA of the SCOUT preliminary results. The European Medicines Agency (EMA) suspended marketing authorization for all anti-obesity medicines containing sibutramine in January 2010.

The company also conducted several analyses that concluded that people with pre-existing cardiovascular disease should not take sibutramine. Meridia can cause serious side effects including large increases in blood pressure or heart rate in some people. Patients should call their doctor right away if they have symptoms of high blood pressure such as headache, dizziness or blurred vision.

For more information: www.sibutramine.com

Related Content

Xarelto Significantly Reduces Major Cardioavascular Events in Stable CAD and PAD Patients
News | Pharmaceuticals| October 18, 2017
October 18, 2017 — Results from the pivotal Phase 3 COMPASS study found that the...
News | Pharmaceuticals| October 04, 2017
October 4, 2017 — MyoKardia Inc.
News | Pharmaceuticals| September 12, 2017
September 12, 2017 — Inclisiran lowers low-density lipoprotein (LDL, or “bad”) cholesterol for up to one year in pati
Merck Announces Results of REVEAL Outcomes Study of Anacetrapib
News | Pharmaceuticals| September 11, 2017
Merck and researchers in the Clinical Trial Service Unit at the University of Oxford announced the publication and...
Statins Associated With Improved Heart Structure and Function
News | Pharmaceuticals| May 26, 2017
Statins are associated with improved heart structure and function, according to research presented at EuroCMR 2017, May...
Feature | Pharmaceuticals| May 16, 2017
May 16, 2017 – Results of a groundbreaking clinical trial demonstrate the effectiveness of a novel, fast-acting nasal
Prescribing Patterns Change Following Direct Marketing Restrictions
News | Pharmaceuticals| May 05, 2017
A study of how policies restricting pharmaceutical promotion to physicians affect medication prescribing found...
EBBINGHAUS study, evolocumab, repatha, statin therapy, cognitive issues, ACC.17 study
News | Pharmaceuticals| April 03, 2017
There is no evidence that adding a new cholesterol-lowering drug to treatment with a statin causes memory loss or other...
synthetic HDL-C injection, cholesterol, arterial plaque, heart attack patients, CARAT trial, ACC.17, clinical study
News | Pharmaceuticals| March 29, 2017
Injection of a novel form of synthetic high-density lipoprotein cholesterol (HDL-C), or good cholesterol, into the...
heart-lung machine, ECMO, levosimendan, heart failure drug, cardiovascular surgery outcomes, ACC.17 study
News | Pharmaceuticals| March 28, 2017
When used as a preventive measure during heart surgery, the heart failure drug levosimendan did not significantly...
Overlay Init