Gilenya Safety Questioned Following Patient Death

Gilenya has raised safety concerns after a patient taking the multiple sclerosis medication died last month. Gilenya is manufactured by Novartis AG. The patient died on November 23 after starting Gilenya treatment.

Gilenya is the first pill approved by the U.S. Food & Drug Administration (FDA) for the treatment of multiple sclerosis, a devastating neurological disease, noted Bloomberg News.

Erick Althoff, a spokesman for Novartis AG, which is based in Basel, Switzerland, said in an email to Bloomberg News that Gilenya’s involvement in the patient’s death can neither be neither excluded or confirmed. This fatality is the first reported death that has occurred within 24 hours of a patient taking his/her first dose of Gilenya, said Althoff, who added that 28,000 patients are taking Gilenya, said Bloomberg News.

Gilenya was approved in the U.S. in 2010 and was cleared to be sold in Europe earlier this year. According to Bloomberg News, Gilenya is one of several products that Novartis is hoping will increase sales as patents on other Novartis drugs begin to expire, including some key medications. “In the case of MS drugs, there is often significant safety baggage of different sorts,” Tim Anderson, an analyst for Sanford C. Bernstein Ltd., wrote in a note to investors. Anderson wrote.

The patient’s specific cause of the death has not yet been determined, said Novartis; however, sudden death “smacks of being cardiovascular in nature,” wrote Anderson, said Bloomberg News. Anderson added that the potential for a temporary slowdown in heart rate after patients begin Gilenya treatment is one reason a recommendation is called for to monitor Gilenya patients in a doctor’s office as soon as treatment begins, wrote Bloomberg News.

The patient who died started treatment November 22 and was monitored “without incident” for six hours following the first dose, Althoff said, according to Bloomberg News. Novartis said it provided the case’s details to the FDA and other regulatory authorities.

Novartis recently made headlines for its oral bisphosphonate, Zometa, and Zometa’s involvement in dead jaw lawsuits. We previously wrote that a jury agreed that the drug maker neglected to appropriately warn about the risks connected to its bone-strengthening medications, Zometa and Aredia, such as severe jaw damage.

In 2005, the FDA ordered that the labels for bisphosphonates be updated to include warnings about osteonecrosis of the jaw, a condition also known as dead jaw syndrome. Last year, warnings were added to the “Warnings and Precautions” section regarding their association with atypical femur fractures. The FDA is currently reviewing a possible link between bisphosphonates and esophageal cancer.

In addition to a number of lawsuits, we recently wrote that a panel of FDA advisors said that Fosamax and similar bone drugs need stronger warnings regarding duration of use because of possible long-term risks.