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FDA Clamping Down on Abuse of an OTC Decongestant

FRIDAY, March 26, 2021 -- Makers of inhalers that contain the nasal decongestant propylhexedrine should make design changes to prevent misuse, the U.S. Food and Drug Administration says.

Propylhexedrine is a nasal decongestant in over-the-counter inhalers and right now is "only marketed under the brand name Benzedrex," the FDA said. The agency said that propylhexedrine is effective and safe when used for short periods as directed for relief of congestion due to colds, hay fever, or other upper respiratory allergies. But misuse can bring dangers.

"Benzedrex inhalers can be legally purchased, but propylhexedrine abuse occurs as people try to find legal ways to get high or increase productivity and concentration," according to the National Capital Poison Center. "There have been many reports of toxicity associated with propylhexedrine extracted from an inhaler and swallowed or injected. Swallowing the contents of one propylhexedrine inhaler has caused heart attack and lung injury in adults and children."

The FDA warns that reports of abuse and misuse of propylhexedrine have been on the rise. The drug can lead to serious problems -- including fast or abnormal heart rhythm, high blood pressure, and paranoia -- that can result in hospitalization, disability, or death. "We are requesting that all manufacturers of [over-the-counter] propylhexedrine nasal decongestant inhalers consider product design changes that support its safe use," the FDA said in a news release. "For example, modifying the product to create a physical barrier that would make tampering with the device and abusing the propylhexedrine inside more difficult."

Reducing the amount of propylhexedrine in inhalers could also lower the risk for serious side effects, the FDA noted.

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