Novartis Issues Safety Guidelines for Gilenya

Novartis Pharmaceuticals Canada Inc. issued new safety recommendations regarding the risk of serious heart-related side effects associated with the use of its multiple sclerosis drug Gilenya (fingolimod).

The Canadian Press reports that the safety recommendations follow reports that some users of the drug suffered from heart-related side effects, including temporary but serious irregular heartbeat, within hours of taking the initial dose.

Gilenya causes the heart rate to slow down in the first hours after use, although it returns to normal after about one month of treatment, the company said in an advisory issued by Health Canada. The advisory says that isolated cases of serious side effects on the heart and one case of unexplained death have also been observed within 24 hours of the first dose, and may possibly be associated with the drug.

Novartis updated the product monograph to now say that patients who are planning to start Gilenya or resume its use must undergo an electrocardiogram (ECG) prior to and six hours after consumption of the drug. Novartis said that patients should not leave the hospital or clinic for at least six hours after consuming the drug and should be monitored during that time.

People suffering from high blood pressure, cardiac disorders, arrhythmia, and sleep apnea or those who have a high risk of strokes or abrupt loss of consciousness may be at a higher risk of experiencing side effects of Gilenya, according to the advisory.

If you or a loved one has been harmed by a dangerous medication, contact Sokolove Law to find out if a dangerous drug lawyermay be able to help you. For legal assistance, please call 800-581-6358.

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