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Medical News & Perspectives
June 10, 2009

Patients Warned About Risks of Drugs Used for Analgesia, Fevers, Addiction

JAMA. 2009;301(22):2315-2316. doi:10.1001/jama.2009.779

The US Food and Drug Administration (FDA) is requiring tougher warnings about the potential risks associated with over-the-counter medications used to treat pain and fever. The agency also is joining with the Substance Abuse and Mental Health Services Administration (SAMHSA) to promote safer use of methadone as a pain reliever or therapy for opioid addiction.

Over-the-counter painkillers are among the most widely used medications but they also are frequently linked to adverse events—some of them life threatening. Of particular concern are the development of liver failure in patients who inadvertently take too much acetaminophen and the possibility of serious stomach bleeding in some patients who take nonsteroidal anti-inflammatory drugs (NSAIDs). To help make consumers more aware of these risks and of how to avoid them, the FDA is requiring manufacturers to make these key ingredients more prominent on product labels and to add warnings about their risks.