Quebec is proposing new restrictions on Benadryl and other medications containing diphenhydramine as their sole active ingredient.
Under a draft regulation recently published in the Gazette officielle du Québec, those products would no longer be available on pharmacy shelves and would instead be kept behind the counter.
The medications would still be available without a prescription, but pharmacists would be required to record sales in a patient’s file.
The proposed restriction is currently the subject of a public consultation.
The measure was recommended by a Quebec coroner last year following the overdose death of an 18-year-old.
The teen died of acute diphenhydramine poisoning at his home in St-Mathias-sur-Richelieu.
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On the morning of Dec. 11, 2023, the man was found by his mother in his bed, unconscious and laying on his back. Toxicological analysis found the man had a lethal level of diphenhydramine in his blood. The drug is the sedating ingredient in some over-the-counter antihistamines including the brand Benadryl, among others.
The coroner found the circumstances surrounding the death raise questions about the uncontrolled availability of a potentially lethal over-the-counter substance. He noted there is consensus about the risks of poisoning among scientific bodies, but it’s not stored behind the counter.
“I cannot understand why the sale of diphenhydramine is not better controlled,” coroner Vincent Denault wrote at the time. “I can’t understand why diphenhydramine is available over the counter, especially since Gravol, which also contains diphenhydramine, isn’t available.”
Denault noted it wasn’t the first time deaths have occurred due to the drug. The coroner has already weighed in on three previous Quebec investigations.
There was an uptick around in 2020 after the so-called Benadryl TikTok challenge on social media invited users to consume large quantities of medication tablets containing diphenhydramine.
“The deaths of children have put a face to this dangerous trend,” Denault wrote. “The scientific literature confirms that diphenhydramine is consumed in high doses for its euphoric and hallucinogenic effects, and that people have used it to commit suicide.”
Denault’s recommendation was for the provincial office of professions to take steps to amend regulations involving the sale of medicinal products, to classify diphenhydramine intended for oral administration in a section that requires more management by pharmacists.
That management would include creating a file, noting the sale and carrying out a pharmacological study of the file.
–with files from The Canadian Press
