In a long-awaited move, the Food and Drug Administration on Thursday formally began the process of discontinuing the oral administration of a common over-the-counter nasal decongestant, even though the agency last year concluded that the drug was effective in relieving nasal congestion. I concluded that no.
Specifically, the F.D.A. proposed order Remove oral phenylephrine from the list of drugs that pharmaceutical companies can include in over-the-counter products (also known as OTC monographs). Once phenylephrine is removed, drug companies will no longer be able to include it in products that temporarily relieve nasal congestion.
“FDA’s role is to ensure that medicines are safe and effective,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Based on our review of the available data and on the advice of our advisory committee, we are proceeding to the next step in the process proposing the removal of phenylephrine as oral phenylephrine is ineffective as a nasal obstructor.”
For now, this order is just a suggestion. The FDA will hold a public comment period, and if no comments change the agency’s previous conclusion that the drug is not helpful, the agency will finalize its order. Pharmaceutical companies will be given a grace period to reformulate their products.
Reviewed Reviews
The phase-out of phenylephrine has been slow and ongoing over many years. This nasal decongestant was originally approved by the FDA in 1976, but it only became famous after 2006. That year, the Methamphetamine Epidemic Control Act of 2005 went into effect, moving pseudoephedrine, the main ingredient in Sudafed, into the background. Store it on the pharmacy counter to prevent it from being used to make methamphetamine. Because pseudoephedrine is not readily available in drug stores, phenylephrine has become the primary over-the-counter nasal decongestant. And researchers had doubts.
In 2007, an FDA panel re-evaluated the drug, which is said to constrict blood vessels in the nasal passages and widen the airways. The committee supported approval of the drug, but concluded that further research is needed for a full evaluation. Three large, carefully designed studies were then conducted. Two are from Merck & Co. for the treatment of seasonal allergies, and one is from Johnson & Johnson for the treatment of the common cold. No significant differences were found between phenylephrine and placebo for all three.
