United States: The US Food and Drug Administration has said in a new policy that it wants to remove oral phenylephrine, an additive used in cold and cough preparations for decongestant function as the regulator feels, the compound is ineffective, the Health Ministry said on Thursday, as reported by Reuters.
Common Brands and Products Affected
Phenylephrine is used in most of the flu and cold youngsters’ medicines available without prescription; some of the most common brands containing phenylephrine are Benadryl, Advil, Tylenol and other medications.
It is also used in nasal drops for elimination of congestion. But the action relates only to orally administered phenylephrine and not the nasal spray version.
Last year the advisory panel of outside experts decided against the use of orally administered phenylephrine as a nasal decongestant without a dissent and stated that it was unnecessary to conduct any more trials.
Expert Panel Findings and Legal Concerns
Some of the firms that have been named in the law suits includeRe; Procter & Gamble (PG.N) GSK (GSK.L) and many others, by concealing the fact that cold medicines contain the ingredient.
Currently the FDA has invited the public to offer their input concerning this proposed order.
It seems that for the meantime, firms can still advertise drug products with oral phenylephrine as a nasal decongestant.
But the FDA also stated that it would give manufacturers reasonable time to either reclassify drugs that contain oral phenylephrine or withdraw all drugs containing that compound on the market.
The Consumer Healthcare Products Association said in a statement that it was “disappointed in the FDA’s update of the previous negative attitude towards oral phenylephrine.” The association also stated that it would specifically study the proposed order and then forward remarks for consideration, as reported by Reuters.
Industry Response to FDA Proposal
Kenvue, the maker of Tylenol, GSK, Haleon (HLN.L), and Procter & Gamble, which manufactures Panadol, did not respond to Reuters’ request for comment at the time of publication.