Why are ineffective oral decongestants still on store shelves? – Harvard Gazette

by Arjun Singh

The Ineffectiveness of Phenylephrine as an Oral Decongestant: A Lesson in FDA Oversight

Phenylephrine, a common ingredient found in many over-the-counter medications that claim to relieve nasal congestion, has recently come under scrutiny for its lack of effectiveness. A recent advisory panel convened by the US Food and Drug Administration (FDA) unanimously voted that phenylephrine does not work as a decongestant when taken orally. This revelation raises questions about how such an ineffective ingredient became so widespread in the first place, and why it has remained on the market despite mounting evidence against its efficacy.

Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, sheds light on the issue. He explains that phenylephrine is an old product that predates the rigorous evidence-based standards required for new drug approvals today. Prior to the Kefauver Harris Amendments of 1962, drugs did not need to be proven effective before they could be sold. The FDA then embarked on a lengthy process of reviewing medications approved between 1938 and 1962 to determine their effectiveness. However, due to the overwhelming number of over-the-counter drugs on the market, the FDA opted for a different approach.

In the 1970s, the FDA created a system of “monographs” for over-the-counter products, grouping them together and making judgments on their effectiveness through a rule-making process. Phenylephrine was validated under this monograph process, despite the limited and not very rigorous data on its efficacy. Changing the monograph system is a resource-intensive task, which is why OTC drugs like phenylephrine have remained on the market even as evidence against their effectiveness has accumulated.

The ubiquity of phenylephrine as an oral decongestant can be attributed to the need for manufacturers to find alternative active ingredients after many pseudoephedrine products were transferred behind the counter due to concerns about their potential misuse in the production of methamphetamine. Since phenylephrine was included in the OTC decongestant monograph, companies could continue selling their products with the claim of containing a decongestant. However, evidence has been growing that phenylephrine does not work as expected when taken orally.

Despite this revelation, there is no immediate safety risk associated with phenylephrine, which prevents the FDA from using emergency powers to remove the product from the market. If the FDA decides to follow the advisory panel’s finding and withdraw phenylephrine from the OTC decongestant monograph, manufacturers would be required to remove any product containing phenylephrine from the market. However, the administrative process for such a change can be lengthy, as seen in previous cases involving dangerous products like ephedrine.

Dr. Kesselheim expects that some manufacturers may voluntarily comply with the FDA’s decision, but not all of them. Manufacturers have little incentive to reformulate their products or remove them from the market unless there is imminent safety pressure or regulatory enforcement. This raises questions about consumer trust in these companies and the need for better oversight and regulation of over-the-counter products. It also highlights the importance of consulting healthcare professionals before using such products.

Consumers should view this situation as a lesson in the level of evidence behind the products they use. Not all products sold in pharmacies and grocery stores have the same level of scientific backing as prescription medications. It is crucial to have a discussion with a healthcare professional to understand the evidence supporting the effectiveness of these products. Additionally, this issue highlights the crucial role played by the FDA in evaluating and regulating the evidence behind the products available to consumers.

There are efforts to reduce the FDA’s regulatory power, which could be detrimental to public health. Without an expert regulatory body to evaluate the evidence behind products, we risk reverting to a market where drugs like phenylephrine are sold without proper scrutiny. This case serves as a reminder of the importance of a robust regulatory system to ensure the safety and effectiveness of the products we rely on for our health and well-being.

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