The SFDA is Reviewing the Cardiovascular Safety of rosiglitazone (Avandia)

The Saudi Food and Drug Authority (SFDA) notifies healthcare professionals and patients that it is reviewing data obtained from the clinical trials, meta-analyses and observational studies which address the cardiovascular safety profile of rosiglitazone.

The review is ongoing and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time. Once the SFDA completes the review, it will communicate its decision regarding rosiglitazone cardiovascular safety data. Consequently, the SFDA will provide an updated information pertaining to the risk-benefit assessment of rosiglitazone in the treatment of type 2 diabetes.

The SFDA recommends that healthcare professionals to follow the recommendations in the drug label when prescribing rosiglitazone. Patients should continue taking rosiglitazone unless advised by their healthcare professional to review their treatment plan. Patients who are concerned about the possible risks associated with the use of rosiglitazone should discuss this issue with their healthcare professional.

Report Adverse Drug Reactions to the Saudi FDA

The SFDA urges both healthcare professionals and patients to report side effects from the use of reosiglitazone to the SFDA either online, by regular mail or by fax, using the following contact information :

National Pharmacovigilance Center (NPC)

Saudi Food and Drug Authority-Drug sector

3292 Northern Ring Road

Al Nafal District

Riyadh 13312 – 6288

Kingdom of Saudi Arabia

Tel: 012759222 ext. 2334, 2352, 2353, 2354, 2356

Fax: 012107398

Email :

Website: