Onglyza may increase risk of death says FDA
The FDA has published an analysis of the type 2 diabetes drug saxagliptin (Onglyza) which links the drug with a higher risk of death from all causes.
The analysis comes in response to the release of data from post-marketing studies (studies carried out after a drug a drug has been approved for use) into heart safety. The regulators noted that the increases in death were “significant or near significant”. The FDA noted that use of Onglyza was linked with a 27% increased risk of hospitalization for heart failure, compared with placebo, and that the causes of death were not limited to heart problems.
Other type 2 diabetes drugs under review
Onglyza is a type 2 diabetes drug from the DPP-4 inhibitors (gliptins) class of drugs. This class of drugs is one of two drug classes recently identified as being linked with greater rates of heart failure. The Lancet Diabetes and Endocrinology journal published, on 16 March, a study which showed that DPP-4 inhibitor drugs collectively were associated with a 25% increase in risk of heart failure compared to ’standard care’. DPP-4 were not, however, the drug class with the greatest risk of heart failure as the thiazolidinediones (TZD) class of drugs, which includes Actos and Avandia, were linked with a 42% increase in heart failure risk.
Onglyza, manufactured by AstraZeneca, is not the only DPP-4 inhibitor that is being analysed by the FDA. Nesina (alogliptin), manufactured by Takeda, was found not to be linked with an increase in deaths. Another DPP-4 inhibitor drug that will be analysed, once data is made available to the FDA, is Januvia (sitagliptin), manufactured by Merck & Co. The results are expected to be released in June.
No statement has been released by the FDA as to how Onglyza will be regulated in light of the risk. Patients on Onglyza should continue to take their medication. If you have particular cause for concern, discuss these concerns with your doctor.
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