Information on Reductil (sibutramine)
Information on Reductil (sibutramine) – New Zealand
Medsafe (New Zealand Medicines and Medical Devices Safety Authority) has recently
announced it is reviewing the balance of risks and benefits of using Reductil (sibutramine).
Reductil remains available in New Zealand and should be used according to the product
data sheet. Reductil is approved for the treatment of patients who are obese, have
no previous history of cardiovascular disease (which includes heart attack, stroke,
angina or inadequately controlled hypertension) and have been unable to lose weight
through diet and exercise.
If you and your doctor determine you are adequately responding to treatment with
Reductil and do not have a history of cardiovascular disease, you can continue to
use the medicine, in accordance with approved labeling. If you have questions about
the use of the drug, contact your doctor.
In November 2009 Abbott provided Medsafe with the interim results of a clinical
trial known as the Sibutramine Cardiovascular OUTcomes (SCOUT) trial, conducted
by Abbott. Abbott is in ongoing discussions with Medsafe regarding this matter.
Abbott's evaluation of the SCOUT study does not change its assessment that Reductil
has a positive benefit/risk profile when used appropriately in the approved patient
population.
The approximately 10,000 patient, six-year SCOUT study was requested by European
regulatory authorities as a post-marketing commitment to evaluate cardiovascular
safety in high-risk patients. The majority of these patients had underlying cardiovascular
disease and were ineligible to receive sibutramine under the current labeling and
prescribing information.
For further information for New Zealand patients,
please click here for the Consumer Medicine Information (CMI).
Healthcare professionals can also access the Data Sheet here.