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Boxed Warnings Common Among Newly Approved Drugs — Physician’s First Watch

Medical News |
August 18, 2014

Boxed Warnings Common Among Newly Approved Drugs

By Kelly Young

Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH

The number of boxed warnings and withdrawals of new drugs increased after Vioxx (rofecoxib) was pulled off the market in 2004, according to a research letter in JAMA Internal Medicine.

Researchers examined boxed warnings and safety-related withdrawals for over 500 drugs approved between 1996 and 2012. Over a third of these drugs were eventually given boxed warnings, and over 40% of the warnings were added after the drugs had been on the market (median 4 years after approval). Drugs were given boxed warnings more frequently after 2004, when the FDA tried to improve drug safety surveillance following Vioxx's withdrawal.

The authors conclude: "Clinicians should be aware of the prevalence and growing numbers of boxed warnings and the importance of continued adverse event reporting for identifying new safety concerns."

A related opinion piece is critical of the FDA's new draft guidance that would allow drug companies to present physicians with peer-reviewed articles showing that risks for a given drug are lower than what the FDA-approved label says.

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