ADR that result in revision of patient information
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| The United States: FDA Drug Safety Communication: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod) |
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FDA has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod). The agency also has evaluated additional clinical trial and postmarket data for Gilenya, including reports of patients who died of cardiovascular events or unknown causes. FDA could not definitively conclude that Gilenya was related to any of the deaths. However, based on its reevaluation of the data, FDA remains concerned about the cardiovascular effects of Gilenya after the first dose. Data show that, although the maximum heart rate lowering effect of Gilenya usually occurs within 6 hours of the first dose, the maximum effect may occur as late as 20 hours after the first dose in some patients.
For this reason, Gilenya is now contraindicated (FDA advises against its use) in patients with certain pre-existing or recent (within last 6 months) heart conditions or stroke, or who are taking certain antiarrhythmic medications.
FDA continues to recommend that all patients starting Gilenya be monitored for signs of a slow heart rate (bradycardia) for at least 6 hours after the first dose. FDA is now recommending hourly pulse and blood pressure measurement for all patients starting Gilenya. Electrocardiogram (ECG or EKG) testing should be performed prior to dosing and at the end of the observation period. Cardiovascular monitoring should continue until any symptoms resolve.
In addition, FDA is now also recommending that the time of cardiovascular monitoring be extended past 6 hours in patients who are at higher risk for or who may not tolerate bradycardia. Extended monitoring should include continuous ECG monitoring that continues overnight.
Healthcare professionals are encouraged to review the updated drug label for Gilenya, and note specific FDA recommendations for monitoring patients and the new contraindications for use in certain patients.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm284355.htm
In Hong Kong, Gilenya (fingolimod) is a prescription medicine and registered by Novartis Pharmaceuticals (HK) Ltd.. News related to this drug has been released by US FDA, EMA and Health Canada and were posted on the website of Drug Office on 21 December 2011, 21 January, 2012, 28 February 2012 and 21 April 2012. A letter to inform healthcare professionals was issued on 23 April 2012 and the case will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board. Department of Health will keep vigilance against any new safety information in relation to the drug.
Ends/ Tuesday, May 15, 2012
Issued at HKT 10:55 |
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