On December 15, 2017, the FDA released an updated drug label for Gilenya with increased warnings.
After conducting a routine review of the immunosuppressive drug Gilenya (fingolimod), the Medicines and Healthcare Products Regulatory Agency (MHRA) recently suggested that the drug label for Gilenya be strengthened and revised.
Gilenya is typically used to treat multiple sclerosis (MS) patients whose disease is severe in nature, or is rapidly progressing. It is also used when at least one disease-modifying therapy has failed to improve the patient’s condition.
While Gilenya is not recommended for patients who have a known risk for adverse cardiovascular events, use of the drug has yet to be contraindicated in such patients.
In light of recent findings, however, the EU advised that these warnings be strengthened to contraindications for patients with underlying cardiac disorders.
They based their decision on the following information:
A recent routine EU review identified 44 post-marketing reports of serious ventricular tachyarrhythmia and 6 reports of sudden death worldwide in patients taking [Gilenya (fingolimod)] up to the end of February 2017.
Additionally, in early treatment, Gilenya was found to have the potential to cause cardiac problems such as:
- Persistent bradycardia, which can increase the risk of serious cardiac arrhythmias;
- Transient bradycardia; and,
- Second-degree or third-degree atrioventricular (AV) block.
Risks of Cancers and Serious Infections
Gilenya has also been shown to increase the risk of lymphoma and skin cancers as well as serious opportunistic infections, due to its immunosuppressive nature.
Accordingly, the EU has also called for strengthened warnings of the following side effects:
- Skin cancers
- Malignant melanoma
- Squamous cell carcinoma
- Kaposi sarcoma
- Merkel cell carcinoma
- Serious opportunistic infections
- Fatal fungal infections
- Cryptococcal meningitis
Back in 2015, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) reviewed research on Gilenya and its association with progressive multifocal leukoencephalopathy (PML), a rare brain disease that often leads to death.
In light of the information these agencies uncovered, they deemed it necessary to alter the drug label for Gilenya to include PML as a potential adverse reaction. The most recent drug label for Gilenya includes this warning (accessed 12/18/17).
As new information concerning potential side effects of Gilenya surfaces, it will be interesting to monitor the actions of these regulatory agencies. Perhaps a new Gilenya drug label will soon be required for this drug in the U.S.
We will continue to monitor the medical and regulatory literature concerning Gilenya, and report on any significant findings.
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
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