Media Statement: Sibutramine/Reductil

Medsafe is reviewing the balance of risks and benefits of using sibutramine and will be seeking expert advice from the Medicines Adverse Reactions Committee (MARC). Medsafe will provide further advice to healthcare professionals and consumers following the conclusion of this review.

In the meantime, healthcare professionals are reminded to avoid using sibutramine in patients with a history of coronary artery disease, congestive heart failure, tachycardia, peripheral arterial occlusive disease, arrhythmia, or stroke, as recommended in the sibutramine data sheet.

Medsafe is aware that the European Medicines Agency has recommended the suspension of marketing authorisations for sibutramine. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the risks of these medicines are greater than the benefits. The suspension will remain in place until the company can provide data that are sufficient to allow the identification of a group of patients in whom the benefits of using sibutramine clearly outweigh its risks.

Medsafe is also aware that the United States Food and Drug Administration (FDA) has put additional restrictions on the use of sibutramine. The new restriction states that sibutramine should not be used in patients with a history of cardiovascular disease. This restriction is already in place in New Zealand.

The FDA has stated that they are seeking further advice from their Expert Committee and will issue further advice following these discussions.

As with all medicines, consumers and healthcare professionals are encouraged to report all suspected adverse reactions to the Centre for Adverse Reactions Monitoring.

Members of the public who are using this medicine and have any concerns or questions should discuss these with their healthcare professional.


Additional information
Sibutramine is a prescription medicine and was approved in New Zealand in November 2000 for the management of obesity, including weight loss and the maintenance of weight loss.

Sibutramine is marketed as Reductil in New Zealand.

More information on sibutramine is available on the New Zealand data sheet at: http://www.medsafe.govt.nz/profs/Datasheet/dsform.asp.

Further information from the FDA can be found at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198221.htm

Further information from the European Medicines Agency can be found at: http://www.ema.europa.eu/pdfs/human/referral/sibutramine/3940810en.pdf