Moving Benadryl behind counter won't resolve safety concerns: pharmacists

Sally McQuinn once kept her medicine cabinet stocked withBenadryl, the go-to medication to treat her daughter's multipleallergies: the Ottawa mother of three assumed that because it was sold on pharmacy shelves and didn't require a prescription, it was safe.

But she was surprised by recent headlines highlighting that a growing number of doctors are warning against the use of olderantihistamines, such as diphenhydramine, the active ingredient inBenadryl, because of safety and efficacy concerns.

McQuinn says she will no longer buy Benadryl and instead choosefrom the number of existing alternatives.

"Nobody wants to choose the one that's going to have morenegative consequences," she explains.

The Canadian Society of Allergy and Clinical Immunology (CSACI)released a statement in October recommending curbing the use ofolder first-generation antihistamines in both adults and children.

They said newer antihistamines, including Reactine, Aerius, andClaritin, are safer.

Long-known side effects from standard doses of Benadryl includesedation, cognitive impairment, and possible heart rhythm abnormalities.

Children are particularly at risk of severe consequences, such asseizures and coma, from too high a dose, and research suggests teensusing Benadryl for allergies have lower scores on exams than theirpeers.

Consider moving it: allergists

The CSACI statement called on regulators to consider movingBenadryl and other first-generation antihistamines from pharmacyshelves to behind the counter in order to force an interaction withpharmacists who can explain the issues and suggest alternatives.

Pharmacists, however, say the solution isn't so simple: puttingBenadryl behind the counter, they say, is not practical and won'tresolve the safety concerns. And they have the same concerns aboutmany other over-the-counter drugs.

• Benadryl shouldn't be available over the counter due to potential side effects, allergists say

Consumers would have to speak to a pharmacist, who could declineto provide the medication. But since the drug is approved by Health Canada and is well known, many consumers, will continue to push forit, says pharmacist Barry Power, a spokesman for the CanadianPharmacists Association.

That can create conflict at the drugstore, he adds.

"For many people, the side effect profile isn't a big concern.But if Benadryl were to come on the market today, it might require aprescription, because of the safety profile," he says.

Benadryl's maker, Johnson & Johnson says the products areapproved by Health Canada and "when used as directed, are safe andeffective."

In a statement, Health Canada said products containingdiphenhydramine meet the requirements and regulations of the Foodand Drugs Act. It says it is assessing the allergists' recentstatement "to determine if further risk mitigation measures fordiphenhydramine-containing products are required."

The agency says that it continues to monitor scientific andmedical information as it evolves and would take action if thisinformation required a change to "the regulatory status of productscontaining diphenhydramine."

'Unrealtistic' to move it: Univ. of Waterloo pharmacist

Currently, Benadryl is approved for sale without a prescriptionin locations where a pharmacist is present. This means that it canbe sold in pharmacies and certain grocery stores, but not inconvenience stores or gas stations.

Nardine Nakhla, a pharmacist who teaches at the University of Waterloo in Ontario, says moving all the diphenhydramine-containingdrugs behind the counter is "unrealistic" due to the sheer numberof products that contain these problematic ingredients."

Nakhla says there are also many other drugs, besidesdiphenhydramine, that have similar risk profiles and are available on pharmacy shelves.

Power agrees that the issue of which drugs belong behind thecounter "becomes a bigger question as you start looking (at it)."

Health Canada determines whether a drug should be prescription or non-prescription and outlines the reasons for its use, acceptable dosing, and labelling requirements. But the National Association ofPharmacy Regulatory Authorities (NAPRA) and provincial regulatorybodies decide where non-prescription medicines can be sold.

In a statement, NAPRA said there is a process to request a changein how it can be sold, but "to date, NAPRA has not received arequest regarding diphenhydramine." And, without a request, thereis typically no review. Such a request would typically come from theindustry, but Health Canada, an advocacy group, or any consumer canmake one.

Power says it is "very rare" for more restrictions to be placedon an existing over-the-counter medication. "It is much more commonto have restrictions loosened."

Health Canada and global views

Dr. Joel Lexchin, an emergency physician and pharmaceuticalpolicy researcher in Toronto, says Health Canada "has traditionally, historically, had a pretty laissez-faire attitudetowards (over-the-counter) medications."

In Canada, Benadryl has dosing instructions for all ages ofchildren, including for children under the age of two. In the UnitedStates, Benadryl dosing guidelines say "do not use" for childrenunder two and "do not use unless directed by a doctor" forchildren aged two to five.

And in many countries outside of North America, Benadryl does noteven contain diphenhydramine. The drug's U.K. maker, Johnson & Johnson, confirmed that the product there, for instance, containscetirizine, one of the newer and safer antihistamines.

Health Canada's own guidance document on product labellingrecommends that diphenhydramine-containing products marketed forsleep should carry a warning of "do not give to children less than12 years of age," but there is no such recommendation for the samemedication when marketed for cough or allergies. It says thatalthough diphenhydramine can cause sleep, it can also causeexcitability, and that it can mask other symptoms.

Lexchin says that is not surprising. "It may be more effectivefor one thing than the other, but it's certainly no safer for onething than the other."

Despite their dispute over where in the pharmacy thoseBenadryl-like drugs belong, one thing that the allergists and pharmacists agree on is the need for education.

Whether or not diphenhydramine-containing drugs remainover-the-counter or become behind-the-counter access only, Powersays the goal to improve safety could be achieved through a"concerted education campaign."

He says consumers and healthprofessionals need to understand the benefits, risks, and alternatives to these medications.