Do you have allergies or nasal congestion? US wants to remove phenylephrine from flu drugs

The Food and Drug Administration USA (FDA) proposed stop using the oral phenylephrine as an active ingredient in several over-the-counter nasal decongestants.

The agency explained that its proposed order “is based on effectiveness concerns, not safety” and is not yet final, so for now businesses can continue selling. drugs for temporary relief of nasal congestion containing this ingredient.

However, a final ruling could force companies to remove products containing oral forms of phenylephrine from shelves and reformulate them.

Phenylephrine is found in a wide variety of over-the-counter products such as Sudafed PE, Vicks DayQuil, and Mucinex. In recent years, it has been widely used as a nasal decongestant.

It is thought to relieve congestion by reducing inflammation of the blood vessels in the nasal passages due to allergies, flu or colds.

According to the regulatory agency your proposal to eliminate oral phenylephrine from flu medications is because, in reality, It is not effective in relieving the symptoms of nasal congestion.

The agency reached this conclusion after conducting an exhaustive review of available data on the ingredient, including those used thirty years ago to verify the effectiveness of phenylephrine and more recent ones.

“The FDA has a role to play in ensuring that drugs are safe and effective,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a statement.

“Based on our review of the available data and consistent with the advice of the advisory committee, we are taking the next step in the process of proposing the elimination of oral phenylephrine because it is not effective as a nasal decongestant. » Cavazzoni added.

The FDA first approved phenylephrine for over-the-counter use in the 1970s. However, it was not until the early 2000s that its popularity increased due to legislation placing restrictions on the sale medicine containing a similar ingredient. pseudoephedrine used to make methamphetamine.

Since then, phenylephrine has been questioned not because of its insecurity, but because of its effectiveness. According to cnn in 2007, a regulatory agency advisory committee reviewed the evidence on the compound and determined that “it may be effective” but also suggested that further studies be conducted.

Clinical trials since that meeting have established that phenylephrine, at least in its oral form, is not very effective.

In September 2023, an FDA advisory committee, which again conducted a thorough review of the data, concluded that the medicine given by mouth does not work.

After this meeting, the CVS pharmacy chain decided, as a preventative measure, to withdraw over-the-counter medications containing phenylephrine as an active ingredient.

The FDA will now begin a six-month public comment period, after which it must determine whether the oral drug should be eliminated. The agency added that if this came to fruition, it would give manufacturers “sufficient time” to reformulate products or remove them from shelves.

“Consumers need to know that there are a range of medications and other treatments that are safe and effective to temporarily relieve symptoms of congestion due to allergies or the common cold,” said Theresa Michele, director of the Bureau of Over-the-Counter Drugs. the FDA.