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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.
While the U.S. debates whether to remove the medication from shelves, the decongestant remains available in Canada. The country’s health regulator has stated that it is currently “reviewing” the information to determine whether similar action is needed.
Are cold medications ineffective?
Last year, 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.
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A 2006 law in the U.S. forced the move because pseudoephedrine can be illegally processed into methamphetamine.
After reviewing the data, the advisers unanimously voted that the evidence does not show the effectiveness of orally administered phenylephrine as a nasal decongestant, adding that no more trials were required to prove otherwise.
The Consumer Healthcare Products Association, an American trade association, responded to the FDA proposal, saying it was “disappointed.”
“For decades, people have relied on oral PE to relieve their nasal congestion. We believe Americans deserve access to safe and effective OTC (over-the-counter) medicines and the option to choose the products they prefer for self-care,” the organization said.
The association added the FDA proposal is at “odds” with previous decisions that have said oral phenylephrine is “generally recognized as safe and effective.”
So what is the problem with oral phenylephrine?
Medications like phenylephrine work by increasing blood flow, which helps clear congestion by speeding up the removal of fluid, effectively drying it up.
However, phenylephrine is most effective when applied directly to the affected area, which is why nasal sprays containing it are still available, Rieder explained.
“The reason that they’re not taking phenylephrine nose sprays off the market is because they work,” he said. “The problem with phenylephrine by mouth is the absorption. Because when we take that drug and goes into our intestinal tract, it never really reaches the bloodstream. It is metabolized or the liver gets what’s left.”
It’s not that oral cold medications don’t work; the issue is that they often can’t reach the targeted area effectively, Rieder said.
However, it may feel like these medications are effective because they’re often combined with other ingredients like antihistamines or acetaminophen, which can provide some relief. Additionally, there’s the placebo effect — sometimes simply taking a medication can make you feel better, even if it isn’t directly addressing the issue, he added.
In Canada, phenylephrine is approved for use as an oral decongestant.
Global News contacted Health Canada to ask whether the health regulator plans to keep the oral decongestant on the market.
“Health Canada is aware that an independent advisory committee to the U.S. Food and Drug Administration concluded that phenylephrine taken in oral form is ineffective as a decongestant. This ingredient is in many over-the-counter allergy and cold medicines that are also available in Canada,” a spokesperson said.
“Health Canada will review all available information, including the advice from the advisory committee. If, after reviewing, it is decided that action is needed, in the Canadian context, the Department will take appropriate action to ensure Canadians are informed and have access to safe and effective health products.”
On Monday the Food, Health and Consumer Products of Canada (FHCP), said in a statement that its members have monitored the FDA’s proposal to remove oral phenylephrine as an active ingredient in over-the-counter drug products.
“In Canada, phenylephrine is approved for use as an oral decongestant. FHCP and our members will work with Health Canada to ensure self-care options continue to be readily available for Canadians during the upcoming cold and flu season.”
In the meantime, during cold and flu season, Rieder recommends acetaminophen for aches, an antihistamine for congestion, and a teaspoon of honey if you have a cough, saying these methods have been proven effective.
— with files from Global News, The Canadian Press and The Associated Press
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