The Food and Drug Administration on Thursday proposed removing a common ingredient in over-the-counter cold medicines that was found to have no effect on nasal congestion, despite its widespread use for decades.
The proposal stems from a recommendation issued just over a year ago by a panel of experts who agreed unanimously that the ingredient, called phenylephrine, did not work when taken in liquid or pill form. It is still considered to be effective in nasal sprays.
The ingredient has been used alone and in combination with other pain killers, cough suppressants and other agents meant to ease cold and flu symptoms in medications like Tylenol, Mucinex and Benadryl.
“It is the F.D.A.’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, the director of the F.D.A.’s drug division. “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 agency emphasized that the ingredient was not considered unsafe.
The move brings the agency one step closer to getting products containing the ingredient pulled from store shelves. In issuing the proposal, the F.D.A. also began seeking public comments. The F.D.A. said it would give companies additional time to reformulate their products if the proposal was finalized.
Medical experts have said that patients who discover the ingredient in items in their medicine cabinet need not be concerned. They can safely take the rest of a combination product that includes phenylephrine if it contains other ingredients that are effective. Or they could throw out items that contain only phenylephrine.
Getting the medication off the shelves has been a decades-long effort for Dr. Leslie Hendeles, a pharmacy professor emeritus at the University of Florida. He began raising concerns about the efficacy of the ingredient in the 1990s. It was added to cold and flu treatments as a stand-in for a more effective decongestant, pseudoephedrine, which was moved behind the counter after its use was noted in homegrown methamphetamine labs manufacturing illicit drugs.
In 2007, Dr. Hendeles and a colleague filed an official petition with the F.D.A. asking them to remove the ingredient. Seventeen years later, on Thursday, Dr. Hendeles said that he was excited to see the process move forward.
“It is amazing to me that it took this long, but it’s better than never,” he said.
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