Navigation Links
Abbott Laboratories Agrees to Withdraw Its Obesity Drug Meridia
Date:10/8/2010

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.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

"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)

http://www.fda.gov/Drugs/DrugSafety/ucm228746.htm

Media Inquiries:

Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov

Erica Jefferson, 301-796-4988; erica.jefferson@fda.hhs.gov

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:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):