Saudi Food and Drug Authority Suspends The Authorisation of Rosiglitazone
The Saudi food and Drug Authority has reviewed the safety of Rosiglitazone (Avandia®) which used in treatment of type 2 diabetes mellitus and marketed in Saudi Arabia as Avandia®. Based on growing evidence from clinical trials meta-analyses and observational studies indicating serious cardiovascular adverse events associated with the use of rosiglitazone as, the Advisory Committee for Pharmacovigilance in Saudi Arabia has concluded the followings:
1. The risk of using rosiglitazone outweighs its benefit especially risks of cardiovascular events including myocardial infarction and congestive heart failure in addition to increased risk of fractures.
2. Safer alternatives could be used for treatment of diabetes mellitus are available in Saudi Arabia.
Based on the review it was recommended to suspended rosiglitazone containing product.
Advise to healthcare professionals
1. Prescribers should not begin treatment with rosiglitazone for new patients
2. Thiazolidinediones group may increase the risk of cardiovascular events. Therefore, healthcare professionals should consider this group as a last choice in treatment of diabetes mellitus and should take appropriate precautions when prescribing thiazolidinediones.
3. Healthcare Professionals should discuss with their patients other alternatives available for treatment of type 2 diabetes mellitus.
Advise for patients
1. Patient using rosiglitazone (Avandia®) and rosiglitazone containing products Avandamet® and Avadaryl® should not stop their medications unless advised by their doctors.
On 28/3/1431, the Committee for Medicinal Products Registration in its meeting no. 711 decided to suspend marketing authorisation for a period of six months during which 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. Rosiglitazone containing products marketed in Saudi Arabia are Avandia® , Avandamet® and Avandaryl®
To look at SFDA report please press here
For more information please contact us using the following information:
The National Drug and Poison Information Center
Saudi Food and Drug Authority
3292 North Highway Al Nafal Unit (1)
Riyadh 13312 - 6288
Tel +96612759222 Ext 5390- 5392-5371-5396-5394-5393
Fax +96612057627
http://dpic.sfda.gov.sa