Gilenya Heart Side Effects Lead To Stronger Warnings

U.S. and European regulators are placing stronger warnings on the multiple sclerosis drug Gilenya, calling for electrocardiogram (ECG) examinations for patients taking the drug due to the potential heart risks with Gilenya.

The European Medicines Agency (EMA) issued a press release on Friday, advising doctors not to prescribe Gilenya to patients who have a history of heart problems or who take drugs that lower their heart rates. When the drug is given to patients with heart problems, they should be monitored by ECG before the first dose and continuously for six hours afterwards, the EMA warned.

The FDA is also planning to put similar label warnings in place in the United States, according to information reported last week by the drug’s manufacturer, Novartis. However, the FDA will only require ECG monitoring before the first dose and six hours later, instead of continuously.

The stronger warnings about the potential Gilenya heart side effects may actual signal support for the medication by the regulatory agencies, as there have been growing concerns recently about the medication and calls for restrictions on the use of the medication.

Gilenya (fingolimod) was approved by the FDA in 2010 as an oral treatment for relapsing forms of MS in adults. It is used to reduce how often flare-ups occur and to delay the onset of physical disability caused by MS.

Despite concerns over the safety of Gilenya when it was reviewed, the FDA agreed to fast-track the drug’s approval with minimal testing under a program aimed at getting crucial drugs to the market to address medication needs that have not been met by other drugs.

Prior to approval, the risk of some heart irregularities after the first dose were a concern, as side effects of Gilenya are known to include a decrease in heart rate and/or atrioventricular condition after the first does.  It is also known to increase the risks of vision loss and developing heart blocks or bradycardia when taken with some other drugs, including beta blockers and calcium channel blockers.

In December, the FDA issued a drug safety communication to announce that it was investigating a reported death on Gilenya, which occurred less than 24 hours after receiving a dose of the medication.