Increasing Safety Concerns About Novartis Drug Gilenya Are Primarily Cardiovascular Side Effects And Unexplained Death
In August 2012 Health Canada issued the latest drug safety alert concerning Gilenya (fingolimod), which is is a new kind of immunosuppressant drug that has found a role as a treatment for multiple sclerosis (MS) after failing in clinical trials as a drug to prevent rejection of transplanted kidneys.
From this August 21, 2012 "Dear Doctor" letter sent to Canadian physicians, "GILENYA (fingolimod) - Stronger Safety Recommendations Regarding First-Dose Heart Monitoring and Use in Patients with Heart Conditions", we get the following information:
- GILENYA* is indicated as monotherapy for the treatment of adult patients with the relapsing-remitting form of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the progression of physical disability. GILENYA* is generally recommended in MS patients who have had an inadequate response to, or are unable to tolerate, one or more therapies for multiple sclerosis.
- Isolated delayed-onset cardiovascular events, including transient asystole and unexplained death, have occurred within 24 hours of the first dose of GILENYA*. Health Canada has completed its review, which included a number of international reports of deaths, several of which were considered possibly associated with GILENYA*.
- The majority of these cases have occurred within 6 hours of the first dose and consisted of bradycardia, hypertension, hypotension and dizziness / malaise / palpitations.
Back in May 2012 the FDA issued this email alert, "Drug Information Update- FDA Drug Safety Communication: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)":
The U.S. Food and Drug Administration 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.
From the ISMP QuarterWatch publication dated April 5, 2012, which contained FDA MedWatch Reports data from 2011 Quarter 2, we get this background information:
[Gilenya (fingolimod)] was approved in September 2010, and its safety is currently under review by the FDA, Health Canada, and the European Medicines Agency (EMA) following reports of patient deaths occurring immediately after starting the drug, and as well as for other issues. Also, reviews in the New England Journal of Medicine and the French journal Review Prescrire questioned whether the drug was safe enough for first-line use. Signals seen in the reported adverse events for the second quarter of 2011 reinforce and expand these safety concerns.... [footnotes omitted]
As for the regulatory reviews mentioned in the excerpt above, here is a timeline of those actions taken in the US, Canada, and Europe:
Health Canada is informing Canadians of an ongoing safety review of the multiple sclerosis (MS) drug Gilenya (the brand name for fingolimod). The review was initiated following reports of serious adverse events, including 11 deaths reported internationally. No deaths have been reported in Canada.
The European Medicines Agency has begun a review of the benefits and risks of the multiple-sclerosis medicine Gilenya. This follows concerns over the effects of the medicine on the heart after the first dose.
The review was started following reports of heart problems in patients taking Gilenya, as well as the death of one patient in the United States less than 24 hours after the first dose. The exact cause of this patient’s death is still unexplained.
The U.S. Food and Drug Administration (FDA) has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod). At this time, FDA cannot conclude whether the drug resulted in the patient's death. FDA is continuing to evaluate the case and will communicate any new information that results from this investigation.....
We will continue to monitor the actions taken by drug regulators as regards the safety of Gilenya and report significant developments here.
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