Sibutramine (brand name Reductil) Information - Australia
This information is intended for the Australian market only.
After discussions with the Therapeutic Goods Administration (TGA), Abbott today announced that it has voluntarily ceased marketing and distribution of sibutramine in Australia.
Sibutramine is marketed by Abbott in Australia as Reductil.
Below you will find answers to some of the most frequently asked questions about Reductil.
For treatment advice, please contact your doctor. For other questions, please call the toll-free service number established by Abbott in Australia: 1800 225 311
What are the recommendations for prescribers and patients?
- Doctors should not issue any new prescriptions for sibutramine. They should also review the treatment of patients currently treated with Reductil.
- Patients who are taking Reductil to help them lose weight should make an appointment with their doctor at the earliest 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.
What should I do if I’m currently taking Reductil?
- Please contact your doctor.
Why is Reductil no longer available in Australia?
- Abbott’s discussions with the TGA followed the agency’s comprehensive review of Reductil, including a review of results from the SCOUT study (Sibutramine Cardiovascular OUTcomes Trial), which became available in November 2009.
What can I take instead of Reductil?
- 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.
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. 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 Reductil under the current labeling and prescribing information.
If my doctor instructs me to stop taking Reductil, what should I do with my remaining Reductil capsules?
- You can return your current unused supply of Reductil to the original location of purchase. Refunds for a current 30-day prescription of Reductil will be honoured until November 8, 2010 if the product is returned in its original packaging.
Can I replace my Reductil with a different prescription?
- Please contact your doctor to discuss other treatment options.
Is there a telephone number I can call to ask my questions?
- For treatment advice, please contact your doctor. For other questions, please call the toll-free service number established by Abbott in Australia: 1800 225 311
If I purchased my sibutramine on the Internet, can I still get a refund?
- No. Abbott does not sell sibutramine on the Internet in Australia.
What are the side effects associated with Reductil?
- The most common side effects for sibutramine include trouble sleeping, constipation and dry mouth. Other side effects include a fast heartbeat, increased blood pressure, awareness of the heartbeat (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 medicine Reductil.