Rheumatologists are feeling a double dose of effects from the Food and Drug Administration’s (FDA’s) Risk Evaluation and Mitigation Strategy (REMS), which is designed to improve the safety of certain medications.
Rheumatologists must manage the extra patient education required with certain rheumatologic drugs affected by REMS while they also must keep abreast of REMS information related to other drugs that patients may be taken as prescribed by their primary care physician.
The end result of REMS is more detailed patient education but possible confusion from patients and added responsibility for rheumatologists, say a number of sources familiar with REMS.
The use of REMS was enacted as part of the “FDA Amendments Act” in March 2008 in order to manage known or potential serious risks associated with drugs or biological agents, according to the FDA. “A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks of the product,” according to the FDA Web site.1 A REMS can be required for products not yet formally approved by the FDA or for products already on the market. For example, post-approval studies may reveal serious risks with certain drugs already on the market, according to the FDA. Certain drugs that had risk minimization action plans, or RiskMAPs, are now required to have a REMS.
Six of the 18 new molecular entities approved by the FDA from late March 2008 to the end of December 2008 included a REMS. However, a total of nearly 60 drugs have been issued a REMS since the FDA Amendments Act took effect in March of last year. Of these drugs, a number are used specifically for rheumatologic conditions. These include certolizumab pegol (Cimzia), pregabalin (Lyrica), and etanercept (Enbrel). Tocilizumab (Actemra), for the treatment of moderate to severe rheumatoid arthritis, must have a REMS plan before it will be approved. Roche, which manufactures Actemra, is expected to respond to the FDA’s request for a REMS by the third quarter of this year.
The FDA had to take a closer look at drug safety after the reported risks associated with Vioxx a few years ago, says Alfonso E. Bello, MD, clinical associate professor of medicine at the University of Illinois College of Medicine at Chicago and the Illinois Bone and Joint Institute. “Now, many of our other medications are scrutinized, including nonsteroidal antiinflammatory drugs and biologic agents,” Dr. Bello says.
