ISMP QuarterWatch Report From 2014 States Adverse Events Reports Show That Gilenya Cardiac Risks "were neither rare nor hypothetical"
(Posted by Tom Lamb at DrugInjuryWatch.com)
The safety profile for the Novartis drug Gilenya (fingolimod) has been controversial for some time now, and the concerns about adverse reactions and side effects continue.
As background, in August 2012 we posted this article, "Multiple Sclerosis (MS) Medication Gilenya: Timeline Of Actions Taken In US, Canada, And Europe".
And over the past several years we have been monitoring news reports about Gilenya adverse reactions and suspected side effects at our Pharmaceutical Drug Litigations Updates site.
Last fall, from the September 24, 2014 edition of the ISMP QuarterWatch publication, we received more data and information about the various safety risks associated with Gilenya.
We start with this overview from "Update on Fingolimod (GILENYA)" in the Executive Summary section:
... three years of postmarket and new published data highlight four important safety risks of [Gilenya (fingolimod)].... Adverse event reports for the most recent 12 months showed the cardiac risks were neither rare nor hypothetical.... Also identified was a large group of cases (n = 348) indicating macular degeneration or less specific adverse effects on the eye. .... A third concern was increased infection risk because of the effect of [Gilenya (fingolimod)] on lymphocytes.... Finally, pregnancy risks were a substantial premarketing concern based on animal studies linking the target [Gilenya (fingolimod)] receptor to vascular malformations in rodents and human fetal abnormalities 5/66 (7.6%) of known pregnancies in clinical studies....
... the large volume of reports of serious injury (n = 2,716) equals approximately 17% per patient-year of exposure, showing that [Gilenya (fingolimod)] remains a high-risk drug with multiple toxicities. Additional detail about this calculation and Novartis’ views are discussed in the main report. [emphasis added]
Given the extent and severity of the adverse events reports about Gilenya disrupting normal heart rhythm, we want to go into more depth on the cardiac-related risks associated with this still relatively new MS drug from Novartis.
Strictly Confidential, No Obligation.
From the Results, or main report, section of the September 2014 QuarterWatch from ISMP, we get this additional information about the heart-related problems patients have had when using Gilenya:
Cardiac Rhythm Risks
Severe and fatal cardiac rhythm disturbances were observed during preapproval testing of [Gilenya (fingolimod)], primarily bradycardia and heart block occurring soon after initiating treatment. Several fatalities in testing occurred at higher than the currently approved dose. In response to this risk [Gilenya (fingolimod)] was approved with a recommendation that the first dose be administered with monitoring and observation for the first 6 hours. In the QuarterWatch adverse event data, cardiac arrhythmias were the largest subcategory of reported serious adverse drug events. We identified 473 cases in the cardiac arrhythmia SMQ, including 13 patient deaths, 11 cases classified as life threatening and 141 resulting in hospitalization. While “decreased heart rate” was the most common manifestation reported (n = 175) other cases indicated loss of consciousness or syncope (n = 58) and various heart blocks (n = 62). One case could have report terms in multiple categories. Adverse event data show that cardiac adverse events proved to be a major hazard of this drug in clinical practice. [footnote omitted]
We will continue to watch for reports of heart-related side effects with Gilenya and monitor the activity of drug regulators in the US, Canada, and Europe as regards the safety profile of this controversial Novartis MS drug.