FDAnews Drug Daily Bulletin

Officials Say Diabetes Drugs May Increase Possibility of Amputation

May 18, 2016

European regulators and Johnson & Johnson subsidiary Janssen-Cilag are warning patients taking the diabetes drugs Invokana and Vokanamet of an increased possibility of lower limb amputation due to a drug reaction.

A joint letter from the European Medicines Agency, the UK’s Medicines and Healthcare products Regulatory Agency and the company warned that clinical trials of the drugs demonstrated a two-fold higher risk of a reaction necessitating lower limb amputation, especially toes.

The letter says that the root cause is uncertain, but “dehydration and volume depletion” might be potential factors. In trials with the drugs, it was observed in six out of every 1,000 patients on these drugs.


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