ISMP warns of severe side effects with infliximab therapy

May 1, 2012

The Institute for Safe Medication Practices is warning about the severe side effects associated with infliximab for rheumatoid arthritis, Crohn's disease, and other autoimmune disorders.

The Institute for Safe Medication Practices (ISMP) is warning about the severe side effects associated with infliximab for rheumatoid arthritis, Crohn’s disease, and other autoimmune disorders.

ISMP recently identified 843 cases of serious injury from infliximab, including 33 patient deaths, six cases of permanent disability, two birth defects, and 10 “life-threatening” cases. “In the second quarter of 2011, inFLIXimab generated a signal for 5 severe side effects: life-threatening brain infections, cancers, severe liver toxicity, a lupus-like autoimmune syndrome, and nerve cell damage similar to MS [Multiple Sclerosis],” ISMP stated in its April 2012 QuarterWatch newsletter.

FDA has responded to the adverse side effects by increasing the number of prominent class warnings added to the prescribing information for all of the anti-tumor necrosis factor (TNF) medications. Class warnings include: increased risk of heart failure, increased risk of various cancers including lymphomas, and severe liver damage. However, “the class warning strategy does not provide useful information to permit clinicians to select the safest drug within the class for each patient,” according to ISMP.

As a result, ISMP executives believe that new research is needed to evaluate the comparative safety profiles of infliximab and four other anti-TNF biological products that have beneficial effects on autoimmune disorders.

“In the meantime, doctors and patients should be aware that these products have mostly second-line indications, meaning they should be used only when safer alternative are ineffective or inappropriate,” ISMP wrote.