FDA: Popular over-the-counter-medicines for colds and allergies don’t work 

Phenylephrine, a widely used ingredient in numerous over-the-counter allergy and cold medications, has been deemed ineffective in tablet form by an independent advisory committee to the US Food and Drug Administration. Phenylephrine serves as the primary component in products such as Benadryl Allergy Plus Congestion, Sudafed PE, and Vicks Sinex.

The safety of phenylephrine itself was not under dispute. However, many medical professionals have raised doubts about its efficacy for several years. These products collectively generated nearly $1.8 billion in sales last year, according to FDA data presented to the Nonprescription Drugs Advisory Committee during a two-day meeting.

Last week, the committee voted unanimously against the specific question: “Do the current scientific data that were presented support that the monograph dosage of orally administered phenylephrine is effective as a nasal decongestant?” The committee members agreed that there was no need for further study on the matter.

Committee member Dr. Diane Ginsburg of the University of Texas at Austin College of Pharmacy stated, “We really should not have products on the market that are not effective.”

The FDA indicated that it would consider the committee’s advice but did not provide a timeline. If the FDA decides to reclassify phenylephrine from “Generally Recognized as Safe and Effective” (GRASE), stakeholders will have the opportunity to comment on the proposed change and provide additional data. 

During this process, companies may continue to market products with phenylephrine. However, if the FDA concurs with the committee’s findings, companies may be required to remove phenylephrine-containing products from store shelves or reformulate them.

Phenylephrine received FDA approval for over-the-counter use in the 1970s, but its usage became more widespread after 2005, when legislation restricted access to OTC drugs containing a similar decongestant ingredient called pseudoephedrine.

In 2007, the FDA committee reviewed the available science at that time and reached a different conclusion, suggesting that phenylephrine “may be effective,” but also calling for further research.

Subsequent studies, including three large clinical trials, have demonstrated that the orally administered ingredient is not effective as a decongestant at its typical dosage.

Phenylephrine is considered the most common ingredient in over-the-counter oral nasal and sinus products, as noted by the American Academy of Allergy, Asthma, and Immunology. Last year, the organization supported a citizens’ petition to reevaluate the drug’s over-the-counter status.

Phenylephrine operates by temporarily reducing the swelling of blood vessels in the nasal passages. When the body encounters a respiratory infection or allergies, it responds by sending white blood cells to the nose, throat, and sinuses, leading to swelling in the nasal membranes and the production of mucus.

Decongestants like phenylephrine work by constricting the blood vessels in the sinuses and nose, which in turn reduces swelling and facilitates the drainage of fluids.

In pill form, some scientists argue that phenylephrine is absorbed by the gut and metabolized so effectively that only a small amount reaches the bloodstream, where it is needed to have an impact on the nose.

Additionally, the committee examined other research that had been used to justify the over-the-counter availability of phenylephrine. The FDA determined that the results of these studies were inconsistent, and many did not meet contemporary scientific standards.

Notably, the committee did not address the issue of nasal spray products containing phenylephrine. Studies suggest that such nasal sprays may be effective, at least temporarily, in relieving nasal congestion.

The Consumer Healthcare Products Association, which represents manufacturers of over-the-counter medicines, dietary supplements, and consumer medical devices, has expressed opposition saying a change in the designation of phenylephrine could indeed have financial implications for manufacturers. The association expressed disappointment with the committee’s decision and urged the FDA to carefully consider the overall body of evidence supporting the long-standing use of phenylephrine in over-the-counter products. They also emphasized the potential negative unintended consequences that could arise from any regulatory alteration affecting oral phenylephrine’s status.

The FDA committee acknowledged that if the agency chooses to reclassify phenylephrine and the drug is removed from the market, the FDA will have a responsibility to educate the public about the reasons, ensure that consumers understand the changes, and can make informed choices regarding alternative treatments or medications.