Avandia continues to be in the limelight. As more physicians are aware of its benefits, controversy surrounding its use and possible side effects continue to be the main issue among patients. Further analysis have been done by the European Medicine Agency, the counterpart of the US FDA, on whether the benefits outweigh the risk in the use of Avandia among our diabetic patients:
Finalising a review of the benefits and risks of the thiazolidinediones rosiglitazone (Avandia) and pioglitazone (Actos), the European Medicines Agency has concluded that the benefits of these antidiabetic medicines continue to outweigh their risks in the approved indications. However, the Agency recommended changing the product information for rosiglitazone and agreed further initiatives to increase scientific knowledge on the safety of both medicines.The Agency’s Committee for Medicinal Products for Human Use (CHMP) carried out this review as part of its continuous monitoring of the safety of medicines, because of new information on these medicines’ side effects. This included information on the risk of bone fractures in women, and, in patients taking rosiglitazone, a possible risk of ischaemic heart disease (reduced blood supply to the heart muscle). This raised concerns over the benefit-risk balance of both rosiglitazone and pioglitazone.
Having assessed all available data, the CHMP concluded that the benefits of both rosiglitazone and pioglitazone in the treatment of type 2 diabetes continue to outweigh their risks.
However, the prescribing information should be updated to include a warning that, in patients with ischaemic heart disease, rosiglitazone should only be used after careful evaluation of each patient’s individual risk. In addition, the combination of rosiglitazone and insulin should only be used in exceptional cases and under close supervision.These changes will be introduced in forthcoming regulatory procedures for rosiglitazone-containing medicines. No changes to the prescribing information for medicines containing pioglitazone were considered necessary.
The Committee will review the results of currently ongoing studies. It also recommended that further studies be performed in order to increase the level of scientific knowledge on the two medicines.
Whether the US FDA will follow the same guidelines remain to be seen. What is important to this date is that further studies need to be done. The risk of heart attack is always inherent in any diabetic…whether the use of Avanida increases the heart attack risk was found to be negative in the interim analysis of a well designed prospective study called RECORD…a study specifically designed to address this issue.
The controversy on Avandia started after a metaanalysis of the previous small studies on Avandia was done and showed an increase risk in heart attack.. Unfortunately the medical community does not accept studies of this caliber to suggest a relationship because of the many loopholes associated with analyzing data in a Metaanalysis.
Do check out my blogroll on AVANDIA update for previous posts.
To this date… the agency has said it well:
The Benefits Continue to Outweigh The Risks!