Watchdog to FDA: Restrict Multiple Sclerosis Drug, Gilenya
April 5th, 2012 tmccoy
Individuals suffering from multiple sclerosis who thought they had found a revolutionary breakthrough drug to aid in their fight against the disease may have to think again. Gilenya, billed as “the first once-daily pill for reducing the number of relapses in people with relapsing forms of MS,” has recently been studied closely by the Institute for Safe Medicine Practices after a number of deaths were reported amongst users of the product.
Yesterday, the ISMP officially recommended to the Food and Drug Administration that use of Gilenya should be substantially restricted and patients should be more closely monitored until further appropriate testing is completed. Novartis, the manufacturers of the drug, has been quick to point out the benefits of the drug and that infection rates have been comparable among treatment groups.
However, the ISMP contends that the allowable dosage approved by the FDA is unnecessarily high, and that proper testing of lower doses was postponed in order to fast track the product to the market. Among the injuries reported as a result of Gilenya usage are retinal injuries, infections of the eye, skin, urinary and respiratory tracts, fatal vascular events, liver damage, and increased cancer risk.
