Novartis Announces Gilenya Label is Being Modified to Include New Safety Information Following European, U.S. April 24, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of individuals injured by defective drugs, is warning today that Gilenya (fingolimod), an oral pill for the treatment of multiple sclerosis, has been associated with serious heart side effects, including heart attacks, disruption of heart rhythm and sudden death. On April 20, 2012, Novartis, the maker of Gilenya, announced the drug's label will be modified to include new safety information. The Gilenya label modification follows safety reviews by the U.S. Food & Drug Administration (FDA) and European regulators that were triggered by reports of patient deaths following initial treatment with Gilenya. [novartis.com/newsroom/media-releases/en/2012/1604414.shtml]
According to a statement from Novartis, the new FDA label for Gilenya will indicate that all patients initiating treatment with Gilenya should have an electrocardiogram (ECG) prior to the first dose of the medicine and after the six-hour first-dose observation period in addition to hourly measurement of blood pressure and heart rate. Additionally, specific initiation guidance for patients is now provided to better aid healthcare providers. Further, there are revised recommendations on how to re-initiate therapy should Gilenya be interrupted, Novartis said.
In Europe, the modified Gilenya label will contain similar advice. However, the European label will also recommend continuous ECG monitoring for a minimum of six hours following the first dose, Novartis said. [novartis.com/newsroom/media-releases/en/2012/1604415.shtml]
Gilenya is an oral medication used to treat relapsing forms of multiple sclerosis in adults. According to the FDA, Gilenya may cause serious side effects, such as slow heart rate (bradycardia), which may be related to slowed conduction of electrical impulses from the upper chambers of the heart to the lower chambers of the heart. 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 heart rate usually returns to normal within 1 month after a patient starts taking the drug, the agency said. [fda.gov/Drugs/DrugSafety/ucm284240.htm]
The FDA launched a safety review of Gilenya in December 2011, after receiving a post-marketing report regarding a patient who died within 24 hours of taking the first dose of Gilenya. The European Medicines Agency (EMA) launched a similar review in January 2012, citing 10 additional deaths as being of potential interest. According to the EMA, 6 cases of unexplained death had been reported, three of which were sudden. In addition, other reports included three deaths due to heart attack and one due to disruption of the heart rhythm. [ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/public_health_alerts/2012/01/human_pha_detail_000050.jsp&mid=WC0b01ac058001d126&jsenabled=true]
Parker Waichman LLP offers free legal consultations to victims of Gilenya side effects. If you or a loved one suffered a serious heart problem while taking Gilenya, please contact their office by visiting the firm's Gilenya Injury page at http://www.yourlawyer.com. For the original version on PRWeb visit: http://www.prweb.com/releases/prweb2012/4/prweb9434143.htm