The U.S. Food and Drug Administration (FDA) declared to eliminate phenylephrine from over-the-counter (OTC) medicine products. It is used in an oral dosage form as an active pharmaceutical ingredient (API) for short-term nasal congestion relief. After reviewing existing information from an agency, it was estimated that oral phenylephrine is not an effective active ingredient in nasal decongestant formulations.
Presently, this oral phenylephrine is widely and commonly used in nasal decongestant formations as API in many OTC medications. Some marketed oral drug products consist of phenylephrine as the sole ingredient. Whereas in some medications it is used in combination with other APIs such as acetaminophen and dextromethorphan. The addition of phenylephrine in these formulations does not influence the effectiveness of the other APIs.
Currently, pharmaceutical companies follow proposed orders. These companies may continue to market the OTC medical formulations that contain phenylephrine as an API in nasal decongestant products. This proposed order focuses on the effectiveness of the drug than safety.
Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER) says that “FDA is responsible for ensuring drug’s effectiveness and safety. According to our review and assistance of the advisory committee, we are committed to removing phenylephrine from nasal decongestant oral dosage forms due to its ineffectiveness.” This agency collected all historical information and used it as supportive data for determining the effectiveness of oral phenylephrine 30 years ago whereas the FDA-Nonprescription Drug Advisory Committee collected the new scientific data available. This committee finally concluded that currently available scientific evidence does not support the effectiveness of the recommended dosage of phenylephrine in the OTC marketed oral products such as cough, antiasthmatic drugs, allergy, and cold.
Theresa Michele, M.D., director of the office of nonprescription drug products, CDER, says “Consumers must be aware of effectiveness and safety of various medications and short-term treatments available to relieve symptoms of nasal congestion. Consumers also consult their healthcare professionals regarding these symptoms. Consumers should always see the drug facts label and read the direction of use, precautions, warnings, and contraindications.”
Phenylephrine is also API in nasal spray formulations which is commonly used effectively and quickly for relieving nasal congestion. The FDA action is mainly related to orally administrated phenylephrine and not related to nasal spray for of drug. The public or consumers should submit their comments regarding this proposed order on the FDA portal via OTC monograph@FDA. If, after reviewing these submitted comments, the FDA announces that phenylephrine is not orally effective as a nasal decongestant for temporary relief of nasal congestion.
The FDA plans to issue a final order to remove phenylephrine from oral OTC drug products. After this order, these drug products are no longer available as a nasal decongestant. Manufacturers need to reformulate or withdraw products containing oral phenylephrine after issuing the FDA’s final order.
Reference: Food and Drug Administration. FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review. 2024. https://www.fda.gov/news-events/press-announcements/fda-proposes-ending-use-oral-phenylephrine-otc-monograph-nasal-decongestant-active-ingredient-after
