Gilenya Reviews In Europe, U.S. Prompted By Patient Deaths

Gilenya reviews in Europe and the United States have been prompted by patient deaths. The reports raise worries that Gilenya can harm the heart, said the European Medicines Agency (EMA.

Gilenya, manufactured by Novartis AG is a 0.5 mg oral capsule prescribed for the treatment of relapsing forms of multiple sclerosis (MS) in adults and is used to reduce the frequency of flare-ups (clinical exacerbations) and delay physical disability. Gilenya is the first pill approved by the FDA for the treatment of MS, a devastating neurological disease.

Last month, we wrote that the U.S. Food & Drug Administration (FDA) launched a Gilenya safety review after having receiving a report of a patient with MS who died within 24 hours of taking his/her first dose of Gilenya (fingolimod). The patient died on November 23. Since, said Businessweek, 10 other deaths have been reported in Gilenya patients, including six that were unexplained; three patients suffered heart attacks, one over heart rhythm disruption, according to the EMA, said Businessweek.

“We have been in touch with EMA, and similar to what they are doing, the FDA is conducting an analysis of available data and has not made any definitive conclusions,” Erica Jefferson, an FDA spokeswoman told Businessweek in an e-mail. “We will notify the public once our review is complete to communicate any recommendations or possible label changes.”

Novartis said “The role of Gilenya in the reported cardiovascular events has not been fully established and the cause of this patient’s death is still unexplained,” concerning the first death. “Novartis continues to believe that Gilenya provides an important health benefit,” the drug maker added in its email to Businessweek.

As we previously wrote, the FDA said it was unable to conclude whether Gilenya caused the first patient’s death, but continues to evaluate the case. The agency also said that it believes that Gilenya provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Gilenya follow the recommendations in the approved drug label. The FDA also said that patients with MS should not stop taking Gilenya without speaking with their healthcare professional.

Gilenya may cause serious side effects that include bradycardia (slow heart rate), which may be related to slowed conduction of electrical impulses from the heart’s upper chambers to its lower chambers. These effects generally do not manifest with symptoms; however, when they do, patients can experiences dizziness, fatigue, and palpitations. Typically, heart rate slowing as a result of taking Gilenya usually happens after the first dose, with the heart rate returning to normal within one month.

Gilenya was approved in the U.S. in 2010 and was cleared to be sold in Europe earlier this year and is one of several products that Novartis was hoping would increase sales as patents on other Novartis drugs begin to expire, including some key medications.

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