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# FDA Denies 2013 Anticholinergic Label Petition
- URL: https://www.fdaweb.com/fda-denies-2013-anticholinergic-label-petition/
- Published: 2022-03-08T12:00:00.000Z
- Updated: 2026-09-14T17:35:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151318

FDA has denied a 9/12/2013 petition submitted by two Weill Cornell Medical Center doctors asking that the agency add a warning to labeling for over-the-counter (OTC) drugs with anticholinergic effects. The FDA [response](ttps://downloads.regulations.gov/FDA-2013-P-1001-0005/attachment%5F1.pdf) says the petition stated that the impairment of thinking caused by the ingredients can cause a confusional state. The petitioners also said that taking drug products with the ingredients in conjunction with other drugs with similar effects can result in an acute confusional state or delirium, especially in the elderly.

The agency says that given that little safety data specific to OTC first-generation antihistamines or other OTC drugs with anticholinergic effects are currently available, it does not believe that changing nonprescription drug labeling to strengthen existing Warnings is warranted at this time.

“In the absence of sufficient data to support the regulatory action you seek,” FDA concludes, “the agency believes the current Warnings found on the labeling of OTC drugs with anticholinergic effects, as well as the consumer outreach and education efforts, are adequate to convey the message that first-generation antihistamines and other OTC drugs with anticholinergic effects have central nervous system side effects.”