PRAC: Selexipag Under Review, Starts Antibiotic Safety Review

Megan Brooks

Disclosures

February 10, 2017

Clinicians in Europe can continue to use selexipag (Uptravi, Actelion) in accordance with current prescribing information, the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) said today. The decision was made on the basis of a preliminary review of available data.

PRAC launched a review of the safety of selexipag following the deaths of five patients taking the drug in France. Their review is ongoing. Once completed, final conclusions will be published.

Selexipag is used to treat adults with pulmonary arterial hypertension, a chronic and progressive rare lung disease that can lead to premature death or the need for transplant.

Selexipag 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.

Selexipag was approved in the European Union in May 2016 and in the United States in December 2015.

While the PRAC review continues, the EMA advises that clinicians prescribing selexipag "carefully follow recommendations and precautions in the current prescribing information."

PRAC Antibiotics Review

PRAC also announced today that they are reviewing systemic and inhaled quinolone and fluoroquinolone antibiotics for "persistence of serious side effects" known to occur with these antibiotics. The review will focus on long-lasting effects mainly on long-lasting effects "mainly affecting muscles, joints, and the nervous system," the EMA said in a statement.

The review was started on February 9 at the request of the German medicines authority (BfArM) following reports of long-lasting side effects in the national safety database and the published literature, the committee said.

"There has been no previous EU-wide review specifically focusing on the persistence of the side effects, but the side effects themselves are known and covered in the EU prescribing information for these medicines," PRAC notes.

PRAC will evaluate all available data and determine whether new measures to minimize these risks or modify how these antibiotics are used are needed.

"Quinolones and fluoroquinolones are widely prescribed in the EU and are important options for treating serious, life-threatening bacterial infections. Healthcare professionals using these medicines should continue to follow the official prescribing information," the EMA said.

The review covers cinoxacin, ciprofloxacin, enoxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin, and rufloxacin.

When complete, the PRAC recommendation will be forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures–Human, which will adopt a final position.

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