FDA suggests eliminating popular oral cold medication ingredient due to lack of effectiveness

The U.S. Food and Drug Administration (FDA) has announced its proposal on Nov. 7 to remove oral phenylephrine from the market. Phenylephrine is a commonly used active ingredient in over-the-counter (OTC) cold medications.

After conducting an extensive scientific review, the FDA concluded that oral phenylephrine lacks efficacy in relieving nasal congestion.

Oral phenylephrine is present in numerous OTC products, either on its own or in combination with other ingredients like acetaminophen or dextromethorphan.

Various over-the-counter medications contain oral phenylephrine as a nasal decongestant, including popular brands such as Sudafed PE, Vicks DayQuil, Tylenol Sinus Congestion & Pain, and Robitussin Peak Cold Nasal Relief.

The FDA clarified that the inefficacy of phenylephrine does not affect the effectiveness of other ingredients in treating symptoms like pain or cough.

The FDA’s director of the Center for Drug Evaluation and Research, Patrizia Cavazzoni, M.D., stated, “It is the FDA’s responsibility to ensure the safety and effectiveness of drugs. Based on the available data and the advice of the advisory committee, we are moving to propose the removal of oral phenylephrine as it does not effectively relieve nasal congestion.”

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Until a final order is issued, manufacturers are allowed to continue selling OTC products containing oral phenylephrine.

The FDA is inviting public comments on this proposal, which centers on effectiveness concerns rather than safety issues. If approved, companies will have time to reformulate their products or remove them from the market, according to the agency.

Consumers are advised that there are alternative treatments available for nasal congestion, such as medications containing other decongestants like pseudoephedrine and decongestant nasal sprays.

Non-pharmacological options like saline nasal sprays and humidifiers can also offer relief, especially for children, as stated by the agency.

Theresa Michele, M.D., director of the FDA’s office of nonprescription drug products, emphasized, “Consumers should be aware that various safe and effective drugs and treatments are accessible for temporary relief of congestion symptoms from allergies or a common cold.”

The FDA’s proposal does not impact phenylephrine used in nasal sprays or topical products for hemorrhoids, where it remains effective. The action is limited to orally administered phenylephrine in tablets, capsules, and liquid medicine.

Phenylephrine has been a common ingredient in cold remedies for years, aiming to alleviate nasal congestion by constricting blood vessels in the nasal passages. Recent studies have raised doubts about its efficacy when taken orally, prompting the FDA’s comprehensive review.

Since 2004, phenylephrine has been increasingly promoted as a substitute for pseudoephedrine, a common decongestant. Due to concerns about pseudoephedrine’s role in producing methamphetamine, restrictions were imposed on its sale in 2005.

Currently, phenylephrine is available in the cough-and-cold section without restrictions, while limited amounts of pseudoephedrine can be purchased at a pharmacy with a government-issued ID.

In September 2023, the FDA’s nonprescription drug advisory committee unanimously agreed that existing scientific data do not support the efficacy of orally administered phenylephrine as a nasal decongestant.

Consumers are encouraged to read the drug facts label on OTC medications to identify active ingredients, understand usage directions and warnings. Additionally, the FDA recommends consulting a healthcare professional if nasal congestion persists for more than seven days or is accompanied by a fever.