The FDA wants these cold medicines off the shelves. Should Canada follow?

The FDA has proposed removing phenylephrine, a common ingredient in decongestants, due to its ineffectiveness, which may prompt Canada to review its approval of the drug.

Cold and cough medications containing oral phenylephrine, a common ingredient found in many over-the-counter remedies, may soon disappear from U.S. shelves after the Food and Drug Administration (FDA) recently declared it ineffective.

Many may now wonder whether Canada could be pressured to do the same.

“Health Canada has a mandate to look after what is on the Canadian market, and even though the over-the-counter medications are a little looser than prescription drugs, if you are absolutely positive (the medication) does not work, then you probably have a duty to act,” said Dr. Michael Rieder, a pediatric clinical pharmacologist and professor in the department of pediatrics at Western University.

On Nov. 7, the FDA proposed to remove phenylephrine as an active ingredient used in over-the-counter medicine for the temporary relief of nasal congestion.

Phenylephrine is found in popular decongestants such as Sudafed, Benadryl, Dayquil and other medications stocked on drugstore shelves.

It is also an ingredient in nasal sprays to treat congestion. However, the FDA’s action is only related to orally administered phenylephrine and not the nasal spray form.

“It is the FDA’s role to ensure that drugs are safe and effective,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a media release. “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”

The FDA clarified that, for now, this is only a proposed order, and only a final ruling will impact which products can remain on the market. If the FDA finalizes this order, which could take several months, drug manufacturers would be required to remove products containing the ingredient from store shelves.