Sibutramine - United States
Sibutramine Information
This information is intended for the United States market only.
Abbott will voluntarily withdraw Meridia® (sibutramine hydrochloride monohydrate) Capsules from the U.S. market at the request of the U.S. Food and Drug Administration (FDA).
Below you will find answers to some of the most frequently asked questions about the FDA decision and Meridia. For additional information or concerns, please consult your doctor or contact Abbott Medical Information at 866-257-8909.
Why was Meridia withdrawn?
- The FDA decision was primarily based on a review of results from the SCOUT study (Sibutramine Cardiovascular OUTcomes Trial).
What is the SCOUT study?
- The approximately 10,000 patient SCOUT study was requested by European regulatory authorities as a post-approval commitment. This study was designed to evaluate the cardiovascular safety of sibutramine in patients at high risk for cardiovascular events. The majority of the patients in the study (more than 90 percent) had underlying cardiovascular disease and should not have received sibutramine under the current U.S. prescribing information.
What should I do if I’m currently taking Meridia?
- You should stop taking Meridia and contact your doctor to discuss other treatment options.
What are the recommendations for doctors and patients?
The U.S. FDA recommends:
- Doctors should stop prescribing Meridia. They should also review the treatment of patients currently treated with the medicine.
- Patients should stop taking Meridia and contact their doctor to discuss other treatment options.
- Patients who have any questions regarding Meridia should speak to their doctor.
What can I take instead of Meridia?
- Please contact your doctor to discuss other treatment options.
Can I replace my Meridia with a different prescription?
- Please contact your doctor to discuss other treatment options.
What should I do with my remaining Meridia capsules?
- Please do not send unused Meridia capsules to Abbott, but please refer to the FDA website to review directions for medicine disposal. www.fda.gov
Is there a telephone number or e-mail address where I can send my questions?
- For treatment advice, please contact your doctor. For questions specific to Meridia, please call 866-257-8909 or email www.abbott.com/abtcontactus.
If I purchased my sibutramine on the Internet, can I still get a refund?
- No. Abbott does not sell sibutramine on the Internet.
What are the most common side effects associated with Meridia?
- In placebo-controlled studies, the most common side effects include dry mouth, anorexia, insomnia, constipation, and headache. Other side effects include a fast heart beat, increased blood pressure, awareness of the heart beat (palpitations), headache, anxiety or dizziness.
About Meridia
- Meridia is a weight loss treatment for patients who are obese/overweight and have no previous history of cardiovascular disease.