August 4, 2015 – The U.S. Food and Drug Administration (FDA) reported one confirmed and one probable progressive multifocal leukoencephalopathy (PML) case in a Drug Safety Communication. PML is a rare infection of the brain that can cause changes in balance, coordination, strength, thinking or vision. This is the first time PML is being associated with taking Gilenya (fingolimod-Norvartis), although a previous case of PML had occurred in a Gilenya patient two years prior. It is however suspected that, another drug the patient was taking could have caused the infection.
Gilenya is taken orally to decrease the risk of flares and delay physical disability for patients who have relapsing forms of multiple sclerosis (MS). Information on PML and its possible symptoms will now be included in the labeling for Gilenya. Patients are advised to inform their healthcare providers about any possible symptoms immediately.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.