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Pharmaceuticals / Regulatory Affairs

FDA Partially Grants Petition for Hypnotic Drug Labeling

Dec. 14, 2018

The FDA granted a petition to add warning labels for hypnotic drugs on the risk of injury from falling, but shot down calls for tougher risk assessments by drug sponsors.

Daniel Kripke, co-director of research at the Scripps Clinic Viterbi Family Sleep Center in San Diego, called on the agency to require labeling of mortality hazards for insomnia treatments and barbiturates used on- or off-label to induce sleep.

Kripke argued the risk controls are needed because the drugs — including zolpidem, temazepam, eszopiclone and flurazepam “in all brands and forms” — increase a patient’s risk of all-cause mortality, serious and potentially lethal infections, death at night, cancer, clinical depression, accidental injuries and deaths related to other factors, such as alcohol use, opioid analgesics and other sedatives.

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