Yesterday, February 14, 2017, Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) issued a statement that it would be reviewing the safety of Uptravi after the deaths of five patients in France who were taking the drug.
Uptravi (selexipag) is used as a long-term treatment for pulmonary arterial hypertension, which is a life-threatening condition involving abnormally high blood pressure in the arteries of the lungs. It was approved in the United States in December of 2015.
According to a Medscape article on this topic, Uptravi “is an oral selective prostacyclin receptor agonist that relaxes muscles in the walls of blood vessels to dilate blood vessels and decrease the elevated pressure in the vessels supplying blood to the lungs.”
The drug can be used in combination with endothelin receptor antagonists (ERAs) and/or phosphodiesterase type 5 (PDE-5) inhibitors when these drugs do not work well enough, or on its own in patients who cannot use ERAs or PDE-5 inhibitors.
Once PRAC’s review of Uptravi and its safety is completed, the EMA will publish the findings. In the meantime, Uptravi may continue to be used in line with current prescribing information.
We will continue to monitor the medical literature for the findings of PRAC’s safety review, and provide updates on this page once they have been published.
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
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