Drugs

Petition Asks Committee Review of Anticholinergic Drugs

Two former FDA officials have submitted a petition asking the agency to convene an advisory committee to consider drug products with clinically meaningful central anticholinergic (antimuscarinic) activity. The petition, submitted by Drs. Andrew Mosholder and Marc Stone says the review is needed “in light of the accumulated evidence that prolonged exposure to such products is associated with, and may causally contribute to, the precipitation or acceleration of clinically expressed dementia, including dementia of the Alzheimer type, in middle-aged and older adults.”

Mosholder and Stone specifically ask that FDA convene an advisory committee to review the evidence on the issue and consider making these recommendations:

change the non-prescription status for diphenhydramine and any other centrally acting strongly anticholinergic over-the-counter products to prescription only;
alternatively, require that such products, when sold without a prescription, be packaged to contain no more than six dosages, with the packaging containing a very prominent warning, comparable to that used on cigarette packaging, advising against frequent use;
label prescription products that are strongly anticholinergic with a statement that frequent use may increase the risk of developing dementia, with the warning boxed in labeling of drugs that require chronic or extended use; and
for products containing a Boxed Warning, issue a Dear Healthcare Provider letter from drug sponsors advising providers of the risk and suggesting that providers consider alternative treatments that are less anticholinergic.

The petition says that anticholinergic drugs are used by a large fraction of the population to treat several conditions, often for extended periods, in combination, and without prescription or specialist oversight. It says the risk is modifiable since in most implicated therapeutic categories lower-risk or non-anticholinergic alternatives exist and cumulative central anticholinergic burden can be measured, communicated, and reduced.

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