Cold medicine overview:
- Who: The United States Food and Drug Administration’s (FDA) Nonprescription Drugs Advisory Committee (NDAC) voted that the phenylephrine in cold medicine is not effective when taken orally.
- Why: The 16-member panel unanimously voted that phenylephrine over-the-counter drugs are not effective when taken orally based upon studies of the drugs efficacy.
- Where: The FDA, based in Washington, D.C., held the NDAC meeting virtually.
The phenylephrine in many over-the-counter cold and allergy medicine is not effective, according to the United States Food and Drug Administration’s (FDA) Nonprescription Drugs Advisory Committee (NDAC), CNN reports.
The 16-member NDAC voted unanimously on the recommendation, with the panel saying that studies have shown the cold medicine drug is not effective.
“I voted no based on the pharmacokinetic data and clinical data that was shared,” Dr. Kristy Brittain, a member of the NDAC board, said during the meeting, a video of which is posted on the FDA’s YouTube account. “I believe this is a long overdue change and agree with the risk that would be associated with continued availability and use in the U.S.”
The panel said that phenylephrine is especially not effective for nasal congestion symptoms that an allergy medicine and cold medicine should help resolve.
Drug still available in OTC medications, and vote was suggestion to FDA, industry group responds
Phenylephrine remains available in over-the-counter medications and the committee’s recommendation is a suggestion, the Consumer Healthcare Products Association pointed out.
The group said it believes the NDAC’s vote was against clinical trials and that the drug is a safe and effective decongestant when dosed as labeled.
“We encourage FDA, before making any regulatory determination, to be mindful of the totality of the evidence supporting this long-standing OTC ingredient, as well as the significantly negative unintended consequences associated with any potential change in oral PE’s regulatory status,” CHPA President and CEO Scott Melville said in a statement. “While we respect the scientific and public process that allows new science to influence health policy and regulations, we are concerned about previous clinical evidence being inappropriately dismissed and discounted. We look forward to working with FDA in the coming days to further discuss how to best move forward in the interest of patients and consumers.”
Class action lawsuits have also been filed recently over other consumer health products.
A recent class action lawsuit claims GSK Consumer Health Inc. misleadingly markets its Theraflu Emergen-C “convenience pack” to deceive consumers into thinking the pack is effective for alleviating cold and flu symptoms.
Do you take cold or allergy medicine that includes phenylephrine? Let us know in the comments.
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