Common decongestants may soon be pulled from shelves. The Food and Drug Administration (FDA) announced Wednesday its proposal to halt use of oral phenylephrine, an ingredient found in many cough and cold medicines, after concluding that the oral version of the drug is ineffective as a nasal decongestant. Keep reading to find out which medications might be affected and what you can use instead. Why is the FDA trying to remove phenylephrine?
Approximately one year ago, the FDA announced it held a “Non-prescription Drug Advisory Committee meeting to discuss the effectiveness of oral phenylephrine as an active ingredient in over-the-counter cough and cold products that are indicated for the temporary relief of congestion, both as a single ingredient product and in combination with other ingredients.” Does phenylephrine work? What the FDA says
The committee addressed data related to the efficacy of oral phenylephrine and ultimately found that existing scientific data does not provide sufficient evidence that the recommended dosage of orally administered phenylephrine works as a nasal decongestant.
It’s important to note that no concerns were raised about safety issues related to oral phenylephrine at the recommended dose, the FDA said. You don’t necessarily have to discard any products you currently have at home containing oral phenylephrine.
After considering the input of the advisory committee and available evidence, the FDA has agreed and decided to move forward with the recommendation.
“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,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. Which medications contain phenylephrine?
Joe Raedle/Getty OTC nasal decongestants containing phenylephrine either on its own or in conjunction with other ingredients include select cold and cough versions of Advil, NyQuil, DayQuil, Sudafed PE, Robitussin, Mucinex, Tylenol, Theraflu and most Dimetapp products.
Phenylephrine is also an ingredient in nasal sprays to treat congestion, but the FDA clarified that its move to end use relates exclusively to […]
Does Phenylephrine Work? Effective Alternatives as FDA Moves to Ban Ingredient in OTC Decongestants
