E-DRUG: Marketing Authorization for Sibutramine Cancelled in Saudi Arabia
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Dear Colleagues,
The Saudi Food and Drug Authority (SFDA) announced on January 24, 2010 that
the marketing authorizations for sibutramine (Reductil, Sibutral) have been
cancelled in Saudi Arabia.
These actions were taken due to an increased risk of serious cardiovascular
events seen with the use of the drug and the lack of any data showing that
sibutramine can be safely taken for a long enough period of time to reduce
the serious health consequences associated with chronic obesity.
The lack of evidence of a meaningful health benefit with the drug is clearly
communicated in sibutramine professional product label or product leaflet in
the U.S.:
“The long-term effects of sibutramine on the morbidity and mortality
associated with obesity have not been established.”
In a situation in which data do not support a health benefit for a
treatment, any risk will always outweigh a lack of benefit.
Best regards,
--
Larry D. Sasich, PharmD, MPH, FASHP
Consultant,
Saudi Food and Drug Authority
3292 Northern Ring Rd., Al Nafal Dist,
Riyadh 13312-6288,
Saudi Arabia
Cell Phone: 053 036 9673
+966 1 275-9222 Ext. 2172
E-Mail: lsasich@sfda.gov.sa
E-Mail: larry.sasich@gmail.com