FDA Tells Drugmakers to Test for Benzene Contamination

(Bloomberg) -- U.S. health officials warned pharmaceutical companies that certain ingredients used in drug manufacturing may risk contaminating medications with the carcinogen benzene. 

The Food and Drug Administration is investigating why benzene has been found in a wide range of consumer products this year, in some cases leading to recalls, according to a statement Thursday. It’s possible that a preservative, sodium benzoate, may form benzene under certain conditions, the agency said. In addition, the causes of the contamination may also be related to thickening agents called carbomers and the propellant isobutane, the FDA said. The carbomers most likely would be found in gel hand sanitizers while aerosols need propellants to expel products from the can. 

Recalls related to benzene contamination have hit a number of products this year, from hand sanitizers to a variety of aerosols, including sunscreens from Johnson & Johnson, antiperspirants made by Procter & Gamble Co. and Bayer AG’s Lotrimin and Tinactin foot sprays. Sunscreen and antiperspirants are considered over-the-counter drugs. The World Health Organization’s cancer research arm classifies benzene as a known human carcinogen, among other cancer-causing chemicals like asbestos.

The FDA said drugmakers with products at risk of benzene contamination should test their products and not release any that contain levels above two parts per million. The agency didn’t immediately respond to a question about what drugs prompted the latest warning.

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