May 14, 2012 — The FDA has just concluded a safety study of Gilenya, a new multiple sclerosis drug from Novartis, which was under scrutiny following the deaths of 15 people who died soon after taking their first dose of Gilenya.
The FDA is warning that Gilenya should not be used in patients who have a history of stroke or some types of heart problems.
The FDA decided to conduct the safety review after receiving an adverse event report in November of 2011, regarding a 59 year-old patient died within 24 hours of taking Gilenya for the first time. The agency also reviewed clinical trials and post-marketing safety information.
The FDA cautions that experts still do not know that Gilenya caused the 59 year-old patient’s death. The patient also had significant brain lesions associated with multiple sclerosis, which may have caused sudden death.
However, because so many other people have died of sudden cardiovascular events soon after taking Gilenya, the agency is warning that doctors should not prescribe Gilenya to patients who have a history of cardiovascular disease, heart problems, or patients who are taking certain anti-arrhythmic medications.
Gilenya is known to cause a significantly slowed heart-rate soon after the medication is administered. The warning label already recommends that doctors monitor a patient for at least 6 hours following the first dose, with hourly pulse and blood pressure measurements.
The FDA is also recommending cardiovascular monitoring that extends longer than 6 hours for patients who are at high risk of cardiovascular problems or those who are less likely to tolerate slow heart-rate. This extended monitoring should involve continuous ECG monitoring that continues overnight.