United States: After a prolonged period of debate, the Food and Drug Administration on Thursday suggested that manufacturers pull a compound used in countless nonprescription cold and allergy remedies.
An independent agency was quoted as having stated that a comprehensive analysis of available information established that oral phenylephrine does not ease nasal congestion at all. It arrived more than a year after the FDA advisors unanimously agreed on the same matter, as reported by The NBC News.
FDA Questions Effectiveness
According to the data, “We are taking this next step in the process to propose the removal of oral phenylephrine because it is not as effective as a nasal decongestant,” said Dr. Patrizia Cavazzoni, director of the FDA, Center for Drug Evaluation and Research in the statement.
The FDA said that the proposed order is not safety-based and is a proposed rule and not a final one, which means that the companies can continue to market over-the-counter drugs containing oral phenylephrine at the moment. But a final decision would compel pharmacies to remove off the shelves hundreds of products with oral forms of the ingredient, which is present in some NyQuil, Benadryl, Sudafed and Mucinex products.
Last year, CVS stated that it had already begun the process of removing some medicines containing oral phenylephrine.
Industry and Consumer Impact
A final order would also necessitate many of Procter &Gamble, Bayer, Johnson &Johnson spinoff Kenvue to reformulate many of their oral cold and allergy products.
Suppose no oral phenylephrine is available on the counters. In that case, patients will probably rush for the spray versions of the said drug or for drugs containing other ingredients, which are not addressed by the FDA’s decision.
Retail stores such as CVS and Walgreens could also take a hit: FDA personnel in a power point presentation made last year stated that those stores were able to sold 242 million bottles of drugs with phenylephrine in 2022 with approximately $1.8 billion worth of sales.
The FDA could in particular repeal the drug’s status as a non-prescription drug suitable for «over-the-counter oTC use» or as a drug that is «generally recognized as safe and effective for use. The designation, assigned to older drugs, implies that the manufacturers of the over-the-counter products can add the substance in small amounts without forming an FDA application.
A Long-Running Debate
The meeting of FDA advisors last year resulted from researchers at the University of Florida who applied to the agency asking them to withdraw phenylephrine products from the market alleging that they are not effective than placebo pills in patients with cold and allergy congestion.
The same researchers also questioned the efficiency of the drug in 2007 but the FDA decided the products could remain marketed while further investigation takes place.
But FDA staff, in briefing documents available prior to the panel meeting last year, agreed that oral formulations of phenylephrine do not function at standard or even suprathreshold doses. The staff added that actually, only a very small quantity of phenylephrine gets into the system to assist in addressing congestion.
During the meeting last year, representatives for the Consumer Healthcare Products Association, an association for over-the-counter drug manufacturers, presented no evidence that would alter the FDA staff’s conclusion regarding phenylephrine.
However the group opined that removing oral phenylephrine from the market would be costly to the consumer.
They distributed a questionnaire with statistics indicating that an oral decongestant was taken by 50% of all the households in the U.S within the past one year. It also discovered that the public prefers to take oral decongestants to nasal spray by a ratio of 3 to 1.”
Replacing Pseudoephedrine
Phenylephrine became the active component of OTC cold and allergy preparations in 2006 year of pseudoephedrine sales without prescription in the USA, as reported by The NBC News.
Pseudoephedrine was relocated to the rx section on the counter since it is an ingredient for manufacturing methamphetamine, which is a highly addictive stimulant drug belonging to the central nervous system.