First Pill (Gilenya or Fingolimod) for Multiple Sclerosis Has Side Effects

Gilenya Has Problems

Fingolimod (Gilenya) had been approved by the FDA for relapsing remitting multiple sclerosis. Fingolimod is the first pill available to treat the disease. (Before patients relied on injections.) Fingolimod has been shown to decrease progression of disability from MS. Fingolimod also prevents increasing size of nerve lesions on MRI. Fingolimod works by preventing lymphocytes (immune system cells) from leaving lymph nodes. Less lymphocytes are then available to attack the nerve coverings (myelin sheath).

Frequent side effects include increased liver enzymes, influenza, headache, back pain, cough and diarrhea. Early in therapy, patients must be checked for slowed heart rate. Serious side effects include herpes infections which can be fatal and macular (the part of the eye responsible for central sensitive vision) swelling. Because of the serious side effects, fingolimod is recommended only for MS patients who can't take the injectable drugs.

Other oral drugs for MS may soon be available. Cladribine (a chemotherapy drug) has been submitted for FDA approval. Teriflunomide (a rheumatoid arthritis drug) and laquinimod are in phase III clinical trials.

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