Sibutramine - South Korea (English)
Sibutramine Information
This information is intended for Korea market only.
Abbott will cease marketing and distribution of its sibutramine from Korean market complying with KFDA’s decision and will voluntarily recall the product with KFDA’s recommendation.
Abbott offers sibutramine medicines under the brand name, Reductil, in Korea. Sibutramine is also marketed under other names by other companies.
Below you will find answers to some of the most frequently asked questions about sibutramine.
For treatment advice, please contact your physician. For other questions, please call the dedicated freephone helpline 080-501-6472.
What are the recommendations for prescribers and patients?
- Doctors should stop prescribing sibutramine-containing medicines to obese or overweight patients. They should also review the treatment of patients currently treated with the medicine.
- Pharmacists should no longer dispense sibutramine-containing medicines.
- Patients who are taking a medicine containing sibutramine to help them lose weight should make an appointment with their doctor at the next convenient time to discuss alternative measures to lose weight.
- Patients who wish to stop treatment before seeing their doctor can do so at any time.
- Patients who wish to stop treatment before seeing their doctor can do so at any time.
- Patients who have any questions should speak to their doctor or pharmacist.
What should I do if I’m currently taking sibutramine?
- Please contact your doctor.
Why was sibutramine suspended/withdrawn in Korea?
- The discussion between Abbott and KFDA was based on a review of results from the SCOUT study (Sibutramine Cardiovascular OUTcome Trial), which first became available in November 2009. The approximately 10,000 patient SCOUT study was requested by European regulatory authorities as a post-marketing commitment to evaluate cardiovascular safety in high-risk patients with a history of cardiovascular disease. The SCOUT study was not designed to directly assess the risk/benefit profile of the drug in patients from whom it is specifically intended. The majority of the patients in the study (more than 90 percent) had underlying cardiovascular disease and were ineligible to receive sibutramine under the current labeling and prescribing information.
- The study found that certain patients with pre-existing heart disease taking sibutramine had a 16% greater chance of experiencing a non-fatal cardiac adverse event compared to other patients not taking the drug.
What can I take instead of sibutramine?
Please contact your doctor to discuss other options, since your medical history and other medications need to be considered in the decision.
How do I know whether my medicine contains sibutramine?
- If you are taking Reductil, then you are taking sibutramine. If you are taking a different drug to treat obesity, then please consult your doctor to confirm whether or not your anti-obesity medication contains sibutramine. If it does, make an appointment with your doctor at the next convenient time to discuss alternatives for losing weight. If you wish to stop treatment before seeing your doctor, you may do so at any time.
If my physician instructs me to stop taking sibutramine, what should I do with my remaining sibutramine tablets?
- Please return your unused supply of sibutramine to your pharmacy.
Can I replace my sibutramine with a different prescription?
- Please contact your doctor to discuss other treatment options.
Is there a telephone number or e-mail address where I can send my questions?
- For treatment advice, please contact your physician. For other questions, please call the dedicated freephone helpline 080-501-6472.
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 side effects associated with sibutramine?
- Most common side effects include trouble sleeping, constipation and dry mouth. Other side effects include a fast heart beat, increased blood pressure, awareness of the heart beat (palpitations), headache, anxiety or dizziness.
About sibutramine
- Sibutramine is a treatment for patients who are obese/overweight, have no previous history of cardiovascular disease and have been unable to lose weight through diet and exercise.
- It is the active pharmaceutical ingredient in some medicines, including Abbott-branded medicines Reductil, Meridia, Sibutral, Ectiva and Raductil.
- It acts centrally in the brain where the body's signal for hunger occurs. It reduces food intake by increasing patients' feeling of fullness.
- Sibutramine is not an appetite suppressant. Appetite suppressants suppress the appetite signal so patients do not begin eating.