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FDAnews Drug Daily Bulletin

EMA to Review Safety of Actelion's Hypertension Drug Uptravi Following 5 Deaths

Feb. 21, 2017

The EMA is launching an investigation into the safety of Actelion’s Uptravi, following the death of five patients in France, although a preliminary review found the hypertension drug can continue to be used.

France’s drug regulator requested the review in January, after receiving reports of adverse events that raised concerns about the drug’s safety. The French National Agency for Medicines and Health Products Safety (ANSM) advised that no new prescription of the drug be issued, pending the results of the EMA’s investigation. ANSM is also reviewing the drug’s safety.

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, and ANSM recommends that existing Uptravi treatments should not be discontinued.

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