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U.K. Regulators Issue Gilenya Heart Warning

May 22, 2012 | Parker Waichman LLP

Health officials in the United Kingdom are following a trend set by domestic regulators in issuing a health warning on the multiple sclerosis (MS) drug Gilenya (fingolimod) because it poses the risk of serious complications, especially for patients with prior heart trouble.

According to a release from the Medicines and Health Regulatory Agency (MHRA) in the U.K., Gilenya can cause transient bradycardias and heart block in patients shortly after taking the first dose of the drug. Gilenya is revolutionary in that is the first pill-form drug specifically designed to treat symptoms of MS, a debilitating nerve disease.

MHRA warns, like the Food and Drug Administration and other agencies like them have recently, that the first six hours after dispensing the first dose of the drug is crucial in determining whether a patient will suffer serious adverse side effects from Gilenya. The agency has recommended against prescribing the drug to patients who already suffer from heart complications, specifically a significant QT prolongation or a history or bradycardia, heart disease, heart failure, cerebrovascular disease, and uncontrolled high blood pressure.

It is advised that prescribing physicians monitor patients prior to, during, and after dispensing Gilenya for the first time. A sudden drop in heart rate is a key indicator that a patient is not reacting well to the drug. If a person’s heart rate drops during that six-hour period, the patient should be monitored even longer, and potentially for an overnight situation.

In an updated safety warning dispensed with Gilenya, MHRA is warning against prescribing the drug to patients with 2nd degree Mobitz Type II or higher degree atrioventricular block, sick sinus syndrome, or sino-atrial heart block, a “significant” QT prolongation, or those with a history of “symptomatic bradycardia” or ischaemic heart disease, or a history of myocardial infarction, heart failure, or cardiac arrest.

Patients taking drugs that lower the heart rate should also not be given Gilenya. For these patients, the drug should be dispensed very sparingly and only if other treatments for MS have failed. A doctor and patient should weigh the benefits of taking Gilenya versus its many drawbacks, especially for those with prior heart conditions.

During that first and key dose, patients should undergo a blood pressure test prior to taking the drug and then continuously through the first six hours. Another monitoring should occur after the six-hour window has closed.

Gilenya has been approved to treat relapsing forms of MS and is designed for patients who’ve not responded well to beta-interferon or their condition is severe and worsening quickly. There have been 15 cases of sudden death reported among people taking Gilenya, including several during the first dose. Many of the patients who died while taking Gilenya were suffering from a pre-existing cardiac condition, according to the agency’s release. 

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