Navigation Links
Abbott Laboratories Agrees to Withdraw Its Obesity Drug Meridia

SILVER SPRING, Md., Oct. 8 /PRNewswire-USNewswire/ -- Abbott Laboratories has agreed to voluntarily withdraw its obesity drug Meridia (sibutramine) from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke, the U.S. Food and Drug Administration announced today.



"Meridia's continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke," said John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research (CDER). "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."

Meridia was approved by the FDA in 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.

The FDA requested the market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT was initiated as part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of this 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 to another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.

"The patients in the European SCOUT trial did not have the same characteristics as the patients for the approved indication in the United States; however, these results, combined with other available safety data raised serious questions about Meridia's safety for all patient groups," said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology in CDER.

The agency's analysis of SCOUT was the subject of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee meeting on Sept. 15.

For more information:

Drug Safety Communication: FDA Recommends against the Continued Use of Meridia (sibutramine)

Media Inquiries:

Karen Riley, 301-796-4674;

Erica Jefferson, 301-796-4988;

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
2. Abbott and AstraZeneca Announce Selection of Next-Generation Fenofibrate ABT-335 and CRESTOR(R) Fixed-Dose Combination
3. Abbott Initiates Clinical Study to Evaluate Use of RX Herculink(R) Elite(TM) Renal Stent System for the Treatment of Renal Artery Stenosis
4. Abbotts ABT-874 Shows Positive Results for Maintenance of Response in Phase II Psoriasis Study
5. Abbotts XIENCE(TM) V Everolimus Eluting Coronary Stent Shows Continued Superiority to TAXUS Stent in Reducing Major Adverse Cardiac Events in SPIRIT III Clinical Trial
6. Abbott Announces Positive One-Year Results from the Worlds First Clinical Trial of a Fully Bioabsorbable Drug Eluting Coronary Stent
7. Abbotts m2000(TM) Molecular Diagnostic Instrument and RealTime HIV-1 Test Win Chicago Innovation Award
8. Abbotts HUMIRA(R) (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis
9. Abbotts XIENCE(TM) V Drug Eluting Stent Demonstrates Consistent and Positive Clinical Outcomes Out to Two Years
10. Abbotts Phase III Studies of Investigational TriLipix(TM) (ABT-335), in Combination With Statins, Meets Primary Endpoints on Improving LDL, Triglycerides and HDL
11. Study in JAMA Shows Patients Treated With Abbotts XIENCE(TM) V Drug Eluting Stent Experience Better Outcomes Than Patients Treated With Market-Leading Drug Eluting Stent
Post Your Comments:
(Date:11/25/2015)... , Nov. 25, 2015 On ... first federal bellwether trial against Wright Medical Technology, ... to their Conserve metal-on-metal hip implant device, awarded ... Following a two week trial and three days ... metal-on-metal hip device was defectively designed and unreasonably ...
(Date:11/25/2015)...  Trovagene, Inc. (NASDAQ: TROV ), a developer ... Officer Antonius Schuh, Ph.D., is scheduled to present a ... Jaffray Healthcare Conference. th Annual Piper ... in New York on Tuesday, ... will be available for one-on-one meetings during the conference. ...
(Date:11/25/2015)... , November 25, 2015 ... of self-monitoring blood glucose devices was valued at $11,171.1 ... with a CAGR of 5.7% during 2015 - 2022. ... population and increasing prevalence of diabetes. In addition, the ... care is also contributing to the growth of the ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... 25, 2015 , ... Finnleo, a leader in the traditional and far-infrared sauna ... and far-infrared saunas. , For traditional saunas, Finnleo is offering 20% ... wood, and Finnleo uses only European Grade A Nordic White Spruce from sustainably grown ...
(Date:11/25/2015)... ... November 25, 2015 , ... TyloHelo Inc , North ... , Sauna accessories help improve the bather experience in the sauna, and the ... for the purist looking for simplicity in design to accessories that encourage a ...
(Date:11/25/2015)... ... November 26, 2015 , ... Ministers, senior ... (EU), ANDI Pan African Centres of Excellence, and public R&D institutions, civil societies ... the opening of the 5th African Network for Drugs and Diagnostics Innovation, ANDI, ...
(Date:11/25/2015)... ... November 25, 2015 , ... For the first time, ... Two Organizations, One Beat ” campaign. The partnership between the two groups began in ... in MAP International’s cause. , MAP International was founded in 1954 and is an ...
(Date:11/25/2015)... ... 2015 , ... Lakeview Health, a Jacksonville-based drug and alcohol ... and show through pictures what a positive difference it makes. The social media ... hashtag #FacesOfGratitude on their Facebook, Twitter, and Instagram accounts. Short stories can ...
Breaking Medicine News(10 mins):