E-DRUG: Rosiglitazone (Avandia) suspended from the Saudi Arabian market
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Dear Colleagues,
The Saudi Food and Drug Authority (SFDA) announced on March 14, 2010 that
the marketing authorization for rosiglitazone (Avandia) and all combination
products containing rosiglitazone was suspended for safety reasons. The
suspension is for a period of six months during which time no rosiglitazone
or rosiglitazone containing combination products can be imported into Saudi
Arabia. During the six month suspension the manufacturer has the
opportunity to provide the SFDA with evidence as to why rosiglitazone and
combination products containing rosiglitazone should not be permanently
removed from the Saudi Arabian market.
The basis for the suspension was that there have been no clinical studies
establishing conclusive evidence of macrovascular risk reduction with
rosiglitazone or any other oral antidiabetic drug. And internal US Food and Drug Administration (US-FDA) documents evaluating the benefit and risks of rosiglitazone. These documents were made available to the public for the first time in a letter from Senators Max Baucus and Grassley to US-FDA Commissioner Margaret A. Hamburg. These documents are the primary source of data used by the SFDA in its assessment of the comparative safety and effectiveness of rosiglitazone. This letter and the attached FDA internal documents are available on the U.S. Senate Committee on Finance’s Web site at http://finance.senate.gov/press/Gpress/2010/prg022010b.pdf
Best regards,
Larry
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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 Local: 053 036 9673
Cell International: 011 966 053 036 9673
Office Phone: +966 1 275-9222 Ext. 5164
E-Mail: lsasich@sfda.gov.sa
E-Mail: larry.sasich@gmail.com