PUBLIC ALERT ON ROSIGLITAZONE (AVANDIA, AVANDAMET)
Rosiglitazone belongs to a class of antidiabetic drugs used to treat Type II diabetes. Worrying concerns on this drug were raised when it’s use in exposed patients was associated with increased cardiovascular adverse effects. The European Medicines Agency (EMA) had recommended the withdrawal of the drug from the European market after it concluded that the benefit/risk of rosiglitazone was unfavourable due to its cardiovascular risk.
The US FDA, the French Drug Regulatory Authority and many other drug regulatory authorities also had similar conclusion to the EMA. While the drug has been banned in Europe, Avandia is still available in the US, though with severe restrictions on its use. Consequently, In October 2010, NAFDAC directed Glaxo SmithKline Nigeria, the Marketing Authorization Holder(MAH) of Avandia in Nigeria to develop and forward to NAFDAC a comprehensive risk management plan for the drug as a means of ensuring restricted access by patients. GSK Nigeria has also been advised to ensure that all patients who are currently on Avandia are evaluated by their physicians and any adverse drug reaction observed reported to NAFDAC. NAFDAC also advise that as much as possible patients should be placed on safer alternatives unless the benefit of the use of Avandia far outweighs the risk as determined by the managing physician. The Agency’s position on the continued use of Rosiglitazone has been communicated to healthcare practitioners through a “Dear HealthCare Provider” letter which is available on NAFDAC website; www.nafdac.gov.ng. The Agency will carryout a review of the effects of these directives to the MAH in April 2011 to determine the safety profile in Nigeria population and the consequent appropriate action.