FDA Advisers Question Effectiveness of Leading Decongestant
FDA advisers have recently concluded that the popular decongestant phenylephrine may not be more effective than a placebo in relieving nasal congestion. This conclusion came after a panel assembled by the FDA reviewed the effectiveness of phenylephrine, which has become the main ingredient in over-the-counter decongestants since pseudoephedrine was moved behind pharmacy counters.
If the FDA follows the panel’s recommendations, major drugmakers including Johnson & Johnson and Bayer may be required to remove phenylephrine-based medications from store shelves. The panel also expressed concerns about the safety of studying phenylephrine at higher doses due to its potential to increase blood pressure.
The FDA’s decision to review phenylephrine was prompted by recent research that showed phenylephrine products failed to outperform placebo pills in patients with cold and allergy congestion. The review also found that previous studies supporting phenylephrine’s original approval in the 1960s and 1970s were flawed and outdated.
Larger studies conducted since 2016 further supported the lack of difference between phenylephrine medications and placebos for relieving congestion. However, the Consumer Healthcare Products Association argued that these studies had limitations and that consumers should continue to have easy access to phenylephrine.
Interestingly, the FDA’s latest assessment showed that phenylephrine is more effective when applied directly to the nose in sprays or drops, which are not currently under review. This could potentially open up a new avenue for phenylephrine usage.
The FDA now has the option to remove phenylephrine from the list of effective decongestants for over-the-counter pills and liquids based on the panel’s negative opinion. It is worth noting that the FDA’s nasal decongestants drug list, or monograph, has not been updated since 1995. However, a new law passed in 2020 may accelerate the process of updating nonprescription ingredient standards, potentially impacting the future status of phenylephrine.
