If the US Food and Drug Administration (FDA) pulls cough and cold medications containing the active ingredient phenylephrine from shelves, it will set off a wave of drug supply chain problems, researchers from the University of Pittsburgh and the University of Toronto assert today in JAMA.
In September 2023, the FDA's Non-prescription Drug Advisory Committee reviewed new data on phenylephrine, concluding that it is ineffective. The committee recommended that the drug, used in many over-the-counter nasal decongestants as a single ingredient or in combination with other ingredients, be removed from the market.
For today's study, the researchers analyzed pharmacy and retail-outlet purchases of phenylephrine and pseudoephedrine—the only two nasal decongestants approved by the FDA—from 2012 through 2021 using IQVIA's Multinational Integrated Data Analysis quarterly sales-volume data.
Few multi-symptom alternatives available
During the study period, 732 unique phenylephrine medications (21 stand-alone, 711 combination products) and 495 pseudoephedrine preparations (54 stand-alone, 441 combination) were on the market.
US pharmacies bought 19.8 billion units of phenylephrine products for $3.4 billion and 13.2 billion units of pseudoephedrine preparations for $3.8 billion. Phenylephrine sales declined significantly over time, from 1.68 billion units in 2012 to 0.98 billion units in 2021.
A comparable pathway is needed for drugs that are sold over the counter as exists for post-approval monitoring of the risks and efficacy of prescription drugs.
The researchers said that if the FDA decides to pull phenylephrine, most multi-symptom products will be unavailable as they undergo reformulation, as few pseudoephedrine alternatives are available. The FDA is requesting public comment before taking any action. In the event of an administrative removal of these products, the authors said clinicians and consumers could substitute oral pseudoephedrine or intranasal decongestants such as phenylephrine or oxymetazoline.
"The FDA needs to hold over-the-counter drugs to a standard of effectiveness similar to that of prescription drugs," Timothy Anderson, MD, assistant professor of medicine at the University of Pittsburgh, said in a university news release. "A comparable pathway is needed for drugs that are sold over the counter as exists for post-approval monitoring of the risks and efficacy of prescription drugs. This will require a substantial investment in infrastructure to expand capacity."