EMA Reviews Safety of PAH Medicine Following 5 Deaths in France

Regulatory NewsRegulatory News | 14 February 2017 |  By 

The European Medicines Agency (EMA) signaled Tuesday that doctors can continue to use Actelion Pharmaceuticals’ pulmonary arterial hypertension (PAH) medicine Uptravi (selexipag) while the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) evaluates its safety following the deaths of five patients taking the medicine in France.

“Based on a preliminary review of available data, EMA advises that Uptravi may continue to be used, both in existing and new patients, but use must be in line with the current prescribing information,” EMA said in a statement.

First approved in the EU on 12 May 2016 (and in the US on 22 December 2015), Uptravi belongs to a class of drugs called oral IP prostacyclin receptor agonists. According to the US Food and Drug Administration, the drug “acts by relaxing muscles in the walls of blood vessels to dilate (open) blood vessels and decrease the elevated pressure in the vessels supplying blood to the lungs.”

EMA’s PRAC says it will further explore all available data in its review and, once completed, final conclusions will be published. The PRAC review follows a letter sent last month from France's drug regulator, known as ANSM, alerting health professionals to the issues mentioned by EMA.

“While the review is ongoing, EMA advises that doctors prescribing Uptravi carefully follow recommendations and precautions in the current prescribing information,” EMA said in a statement. “Patients taking Uptravi should follow their doctors’ instructions and can continue treatment with the medicine. Patients who have any questions about their treatment should speak to their doctor or pharmacist.”

Last Friday, PRAC also warned of “an increase in cases of lower limb amputation, mostly affecting the toes, has been observed in patients taking the type 2 diabetes medicine canagliflozin compared with those taking placebo.”


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