Sibutramine - United Kingdom
This information is intended for the UK market only.
The European Medicines Agency (EMA) has recommended that all medicines containing the drug sibutramine should no longer be prescribed or dispensed in European Union (EU) member countries, as well as Iceland and Norway. Abbott is complying with the agency's recommendation and has suspended marketing of medicines containing sibutramine.
Abbott offers sibutramine medicines under the brand name, Reductil, in the UK. Sibutramine is also marketed under other names by other companies.
Below you will find answers to some of the most frequently asked questions about the EMA recommendation and sibutramine. For additional information, we would suggest you consult your physician or contact Abbott at the number listed below.
What are the recommendations for prescribers and patients?
The EMA recommends in Europe that:
- 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.
- Pharmacist 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 have any questions should speak to their doctor or pharmacist.
What should I do if I’m currently taking sibutramine?
- Please contact your doctor. See also EMA and MHRA recommendation
Why was sibutramine suspended in Europe?
- The Committee for Medicinal Products for Human Use (CHMP) of the EMA voted to recommend that suspension of marketing authorisations for all medicines containing sibutramine in the EU, as well as Iceland and Norway.
- The CHMP’s recommendation was based on a review of results from the SCOUT study (Sibutramine Cardiovascular OUTcome Trial), which became available in November 2009.
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?
- Please consult your doctor to confirm whether or not your anti-obesity medication contains sibutramine. If it does, the EMA recommends you 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.
What is the SCOUT study?
- 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, and did not 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.
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?
- Only you and your physician can determine that.
Is there a telephone number or e-mail address where I can send my questions?
- For treatment advice, please contact your GP. For other questions, please call the dedicated freephone helpline 0800 999 2160 or email firstname.lastname@example.org.
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.
- 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 (only Reductil is marketed by Abbott in the UK).
- 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.
For treatment advice, please contact your GP. For other questions, please call the dedicated freephone helpline 0800 999 2160 or email email@example.com.