QuarterWatch™ Reports

Signals for Fingolimod (GILENYA) and Infliximab (REMICADE)

In this issue of QuarterWatch™ we analyze signals for severe side effects associated with two different but important drugs that suppress elements of the human immune system, fingolimod (GILENYA) for multiple sclerosis, and infliximab (REMICADE) for ulcerative colitis, rheumatoid arthritis, and other autoimmune disorders. We also update our findings for dabigatran (PRADAXA) and metoclopramide (REGLAN). 

Key Findings:

  • The signals for fingolimod raise the question whether enough is known about the troubling safety profile of this drug to justify its continued unrestricted use.
  • While infliximab and four other anti-TNF biological products have beneficial effects in a range of autoimmune disorders, they are also associated with the risk of severe adverse effects.
  • The FDA can improve the quality of the AERS system by clarifying the definition of adverse drug events that are non-serious.

QuarterWatch™ is an independent publication of the Institute for Safe Medication Practices (ISMP). We analyze computer excerpts from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). These reports (best known as MedWatch reports) are a cornerstone of the nation’s system for monitoring the safety of prescription drugs after FDA marketing approval.