Gilenya Side Effects Injury Lawsuit. Do you know someone who died unexpectedly while taking the multiple sclerosis drug, Gilenya? Gilenya is currently being reviewed by regulators in the U.S. and Europe, following the sudden deaths of several patients being treated with the drug. If someone you love died suddenly after starting treatment with Gilenya, you may be entitled to receive damages for medical bills, lost wages, pain and suffering, and wrongful death.
Lawyers at Parker Waichman LLP who specialize in defective drug litigation are currently investigating potential lawsuits on behalf of ‘Gilenya’ victims and their families, and we are offering free legal evaluations to the families of anyone who died unexpectedly while taking ‘Gilenya’. If someone you love died after using this drug, we urge you to contact one of our Gilenya lawyers today to protect your legal rights.
‘Gilenya’ was approved for the treatment of relapsing-remitting multiple sclerosis in 2010. It was the first multiple sclerosis drug approved in pill form, and is used to reduce the frequency of multiple sclerosis flare-ups and delay physical disability. Since its approval, more than 30,000 people worldwide have taken ‘Gilenya’.
One of Gilenya’s known side effects is bradycardia, or slow heart rate. According to the U.S. Food & Drug Administration (FDA), these effects usually do not cause symptoms, but they can cause dizziness, fatigue, and palpitations. A slowing of the heart rate due to ‘Gilenya’ mostly occurs after the first dose, and the heart rate usually returns to normal within 1 month after patients start taking the drug.
In December 2011, the FDA announced it was conducting a Gilenya safety review after one patient died within 24 hours of taking their first dose of ‘Gilenya’. In January 2012, the European Medicines Agency (EMA) announced it was also conducting a Gilenya safety review, after the maker of the drug, Novartis AG, confirmed that 10 more fatalities had occurred among Gilenya patients, including six unexplained deaths, three heart attacks and one due to disruption of heart rhythm.
In announcing its safety review, the EMA advised doctors to increase patient monitoring after the first dose of ‘Gilenya’ is given. That includes electrocardiograms before treatment and for the first six hours after the first dose, and then checking blood pressure and heart rate every hour, the EMA said. After six hours, patients with a slow heart rate or problems with electricity conduction in the heart should be watched until their condition has improved.