Several deaths have been reported in patients taking selexipag, a molecule that has European marketing authorization.
As of today, doctors should no longer prescribe Uptravi (selexipag) to new patients. This Tuesday, the ANSM issued an information point concerning this medicine used for the oral treatment of pulmonary arterial hypertension (PAH).
Deaths have been reported in patients taking Uptravi. If the imputability of the molecule has not been established to date, the health authorities ask prescribers not to initiate new treatments with Uptravi, pending further investigations into the pharmacovigilance cases reported.
Side effects
On the other hand, patients should especially not stop or change their treatment on their own. Doctors are invited to “reassess the merits and safety of continuing current treatments with selexipag, and to assess the need for possible close monitoring of treated patients”.
In addition, the ANSM asks prescribers “to respect the contraindications and warnings mentioned in the marketing authorization (AMM). Selexipag, a prostacyclin receptor agonist, has European Marketing Authorization under the name Uptravi. It has been available in France since May 2016, and marketed in several European countries as well as in the United States.
The European public drug evaluation report, available on the website of the European Medicines Agency, lists the side effects most commonly observed with Uptravi, “which may affect more than one in 10 people”: headache, diarrhea, nausea and vomiting, jaw pain, myalgia (muscle pain), leg and arm pain, arthralgia (joint pain) and flushing. “These effects are mild to moderate and are more common with increasing the dose of Uptravi.”
Contraindicated
The file also mentions the contraindications. “Uptravi should not be used in patients who have had a heart attack within the past 6 months, severe coronary artery disease (heart disease caused by blockage of the blood vessels supplying the heart muscle) or unstable angina pectoris”, can we read.
The drug should also not be prescribed to patients with severe arrhythmias (unstable heartbeat) or abnormal heart valves, or to patients who have had a stroke within the past 3 months.
“Chance”
The file mentions “a small obvious increase in the mortality rate observed in patients treated with Uptravi compared to those treated with placebo”, but the European agency estimated that “this result was due to chance or to the way in which the ‘study was designed and therefore had no impact on the benefits and risks of the drug.
In France, the ANSM approached the European Committee for the Evaluation of Pharmacovigilance Risks (PRAC) so that an evaluation of this signal could be carried out in a coordinated manner.
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