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Cold and cough medications that contain oral phenylephrine, a common ingredient found in many over-the-counter medicines, may soon disappear from U.S. shelves after the Food and Drug Administration (FDA) recently declared it ineffective.
Many may now be wondering whether Canada can be pressured to do the same.
“Health Canada has a mandate to take care of what is in the Canadian market, and even though the over-the-counter medications are a little looser than prescription medications, if you are absolutely certain that (the medications) are not working, then you will likely have a duty to act,” said Dr. Michael Rieder, a pediatric clinical pharmacologist and professor in the department of pediatrics at Western University.
On November 7 the FDA proposed to remove phenylephrine as an active ingredient used in over-the-counter medications for the temporary relief of nasal congestion.
Phenylephrine is found in popular decongestants such as Sudafed, Benadryl, Dayquil, and other medications found on drugstore shelves.
It is also an ingredient in nasal sprays to treat congestion. However, the FDA's action only affects orally administered phenylephrine and not the nasal spray form.
“The FDA's role is to ensure that medications are safe and effective,” Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a news release. “Based on our review of the available data, and in accordance with the advisory committee's advice, 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 just a suggested orderand only a final ruling will affect 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 pull the drug from shelves, the decongestant remains available in Canada. The country's health regulator has said it is currently “reviewing” the information to determine whether similar action is necessary.
Are Cold Medicines Ineffective?
Last year, the FDA gathered its outside advisers to take another look at phenylephrine, which became the lead drug in over-the-counter decongestants when medications with an older ingredient — pseudoephedrine — were moved behind pharmacy counters.
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A 2006 law in the US forced this step because pseudoephedrine can be illegally processed into methamphetamine.
After reviewing the data, the consultants were unanimous in their view that the evidence does not demonstrate the effectiveness of orally administered phenylephrine for nasal congestion, adding that no further studies were needed to prove otherwise.
The Consumer Healthcare Products Associationa US trade association, responded to the FDA's proposal, saying it was “disappointed.”
“For decades, people have relied on oral PE to relieve nasal congestion. We believe that Americans deserve access to safe and effective over-the-counter (OTC) medicines and the ability to choose the products they prefer for self-care,” the organization said.
The association added that the FDA's proposal is “contrary” to previous decisions that have said oral phenylephrine “is generally recognized as safe and effective.”
So what's the problem with oral phenylephrine?
Medications such as phenylephrine work by increasing blood flow, which clears blockages by speeding the removal of fluid, effectively drying it out.
However, phenylephrine is most effective when applied directly to the affected area. That's why nasal sprays containing it are still available, Rieder explains.
“The reason they're not taking the phenylephrine nasal sprays off the market is because they work,” he said. “The problem with phenylephrine by mouth is absorption. Because when we take that drug and it enters our intestinal tract, it never actually reaches the bloodstream. It gets metabolized or the liver gets what's left.”
It's not that oral cold medicines don't work; the problem is that they often cannot reach the target area effectively, Rieder said.
However, it may seem like these medications are effective because they are often combined with other ingredients such as antihistamines or acetaminophen, which can provide some relief. Plus, there's the placebo effect: Sometimes simply taking a drug can make you feel better, even if it doesn't directly solve the problem, he added.
In Canada, phenylephrine is approved for use as an oral decongestant.
Global News contacted Health Canada to ask if 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 has concluded that phenylephrine, taken in oral form, is not effective as a decongestant. This ingredient is found in many over-the-counter allergy and cold medications that are also available in Canada,” a spokesperson said.
“Health Canada will review all available information, including the advisory committee's advice. If, following review, it is determined that action is necessary, the Department will take appropriate action in the Canadian context to ensure that 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 followed the FDA's proposal to remove oral phenylephrine as an active ingredient in over-the-counter medicines.
“In Canada, phenylephrine is approved for use as an oral decongestant. FHCP and our members will work with Health Canada to ensure that self-care options remain readily available to Canadians during the upcoming cold and flu season.
In the meantime, during cold and flu season, Rieder recommends acetaminophen for pain, an antihistamine for congestion and a teaspoon of honey for a cough, saying these methods are proven to be effective.
– with files from Global News, The Canadian Press and The Associated Press
Katie Dangerfield
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