Nearly two decades after an initial expert recommendation, the US Food and Drug Administration has proposed starting the process of 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 move was escalated after a panel of experts – a year ago – agreed unanimously that the ingredient, phenylephrine, did not work when taken in liquid or pill form.
However, reports The New York Times, it is still considered to be effective in nasal sprays.
The ingredient has been used alone and in combination with other painkillers, cough suppressants and other agents meant to ease cold and flu symptoms, in medications like Tylenol, Mucinex and Benadryl.
Patrizia Cavazzoni, director of the FDA’s drug division, said: “Based on our review of available data, and consistent with the advice of the advisory committee, we are … proposing removing oral phenylephrine because it is not effective as a nasal decongestant.”
While the agency emphasised that the ingredient was not considered unsafe, the move brings it one step closer to getting products containing the ingredient pulled from store shelves. It said it would also give companies additional time to reformulate their products if the proposal were finalised.
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. Now in his 80s, 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 home-grown methamphetamine labs manufacturing illicit drugs.
In 2007, Hendeles and a colleague filed an official petition with the FDA asking them to remove the ingredient, citing studies by a company that switched to pseudoephedrine – and found in its internal studies that the alternative had no effect.
Last week, 17 years later, Hendeles said that he was excited to see the process move forward. “It is amazing that it took this long, but better late than never,” he said.
See more from MedicalBrief archives:
The decades-long struggle to get ineffective decongestant off the shelves
Decongestants in cold medicines ‘ineffective’: FDA