Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2014 Jun;10(2):165-72.
doi: 10.1007/s13181-013-0374-z.

Assuring safety of inherently unsafe medications: the FDA risk evaluation and mitigation strategies

Lewis S Nelson  1 , Meredith Loh, Jeanmarie Perrone
Affiliations
Review

Assuring safety of inherently unsafe medications: the FDA risk evaluation and mitigation strategies

Lewis S Nelson et al. J Med Toxicol. 2014 Jun.

Abstract

The decision to approve a drug for clinical use is based on an understanding of its benefits versus the risks. Although efficacy is generally understood at the time of submission to the FDA for approval, the risks are more difficult to assess. Both PubMed (from 2000 to 2012) and the FDA website (www.fda.gov) were searched using the search terms "risk evaluation and mitigation strategy" (REMS). Articles for review were selected by relevance to topic, and their references were searched as well for additional relevant resources. Since the search results were not expected to contain research studies, formal quality assessment and inclusion and exclusion criteria were not utilized resulting in a narrative review. Few directly relevant research studies exist, although supporting documents such as government reports were available. For effective drugs with unclear or concerning safety records, the FDA has the option of requiring a risk evaluation and mitigation strategy, which allows a systematic approach to track and assure safe medication use. Over 100 different medications are currently covered by REMS, and each REMS is developed individually based on the needs of the specific drug or class. Although likely associated with improvements in medication safety, the potential benefit, limitations, and consequences of REMS are not yet fully understood.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

References

    1. Avorn J. Learning about the safety of drugs—a half-century of evolution. N Engl J Med. 2011;365:2151–2153. doi: 10.1056/NEJMp1110327. - DOI - PubMed
    1. Food and Drug Administration (2005) Guidance for industry development and use of risk minimization action plans
    1. HHS Office of Inspector General (2006) FDA’s monitoring of postmarketing study commitments
    1. United States Government Accountability Office (2010) Drug safety: FDA has begun efforts to enhance postmarket safety, but additional actions are needed
    1. Food and Drug Administration Drug Safety Oversight Board. In: fda.gov. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTob.... Accessed 4 Mar 2012

MeSH terms

LinkOut - more resources