Should Canadians still use nasal decongestants? What we know after FDA ruling

The Food and Drug Administration (FDA) ruled Tuesday that a key drug in popular decongestants is ineffective, which one Canadian group of doctors has known for years.

A key ingredient found in oral versions of popular nasal decongestants has been labeled as ineffective by the U.S. Food and Drug Administration (FDA).

Research on the long-questioned drug ingredient was reviewed by American government experts who ultimately voted against its effectiveness Tuesday. The drug, phenylephrine, is found in popular decongestants such as Sudafed, Benadryl Allergy Plus Congestion, Dayquil and other medications stocked on drugstore shelves.

“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” said Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine.

The FDA assembled its outside advisers to take another look at phenylephrine, which became the main drug in over-the-counter decongestants when medicines with an older ingredient — pseudoephedrine —were moved behind pharmacy counters both in the U.S. and Canada.

A 2006 law in the U.S. had forced the move because pseudoephedrine can be illegally processed into methamphetamine. Phenylephrine then launched into popularity as the leading drug in over-the-counter decongestants as a result.

Once a drug is on the market, Health Canada has certain regulatory controls in place.

Drug distributors are required to adhere to the Protecting Canadians from Unsafe Drugs Act (also known as Vanessa’s Law) by reporting on any new concerning serious side effects or if the drug failed to produce the desired effect.

The law applies to an array of products including prescription and over-the-counter drugs, vaccines, gene therapies, tissues and organs, and medical devices.