Drug Safety Label Updates for Multiple Sclerosis (MS) Drugs June 2024
Also updates for Parkinson's drug (Mirapex ER), and lymphoma drug Calquence
MS Drug Label New Warnings
Notable safety label updates were filed at the FDA for several multiple sclerosis (M.S.) drugs (Gilenya, fingolomod, Mayzent, Zeposia).
Multiple Sclerosis Drug Safety Label Updates:
GILENYA FINGOLIMOD
TASCENSO ODT FINGOLIMOD LAURYL SULFATE
PONVORY PONESIMOD
VELSIPITY ETRASIMOD ARGININE
Zeposia OZANIMOD HYDROCHLORIDE
Fingolimod FINGOLIMOD
Mayzent SIPONIMOD FUMARIC ACID
All of the above drugs treat relapsing forms of multiple sclerosis (MS) and have similar label updates. Since there are some differences in the drug label updates, click on the link for the drug above to view the specific drug safety updates for each medication.
Popular MS drug Gilenya (fingolimod) and similar generics and MS drugs in the same category had a drug safety label updates to warn of the increased risk of melanoma and basal cell carcinoma (BCC). Skin examinations are recommended prior to or shortly after the start of treatment and periodically thereafter for all patients, particularly those with risk factors for skin cancer.
Cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients with MS who received Gilenya in the postmarketing setting. Gilenya should be discontinued if PML is diagnosed. Usually PML has only ocured in patients taking Gilenya for at least 18 months. Macular edema (eye swelling) risks were added. Also, information on neoplasms (benign, malignant, and unspecified, including cysts and polyps): melanoma, Merkel cell carcinoma, cutaneous T-cell lymphoma (including mycosis fungoides), Kaposi’s sarcoma, squamous cell carcinoma were added to the label.
Note that less serious, but still concerning, side effects not listed on the label but often mentioned in patient drug reviews, is the side effect of weight gain when taking Gilenya and some other M.S. drugs. For example, see Gilenya reiews on Ask a Patient web site:
Gilenya reviews https://www.askapatient.com/viewrating.asp?drug=22527&name=GILENYA
For MS drug Zeposia, the label was updated to warn that vaccinations may be less effective if administered during ZEPOSIA treatment. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA. Avoid the use of live attenuated vaccines during and for 3 months after treatment with ZEPOSIA.
Mirapex ER (Pramipexole dihydrochloride)
Mirapex ER, a drug commonly taken for Parkinson's disease, had a drug safety label update to warn of the risk of: priapism (prolonged erection of the penis).
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=27
Calquence and Cardiac Arrythmias
Lymphoma drug Calquence (acalabrutinib maleate) had a drug safety update to warn of the risk of cardiac arrythmias.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2122