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FDA rules ingredient in Benadryl, Robitussin, and Sudafed 'is not effective' and may pull products from shelves

Photo by PATRICK T. FALLON/AFP via Getty Images

A review by the Food and Drug Administration declared that a common ingredient in over-the-counter cold and flu medication is not effective and could cause big brands to have to reformulate their medicine.

A two-day review by an FDA panel ruled that phenylephrine, the most common active compound in many brands of cold medication, is "not effective" at standard or high doses compared to a placebo, the Daily Mail reported. The ruling only applies to oral formulations of the ingredient.

Products that could be pulled off shelves or would need to be reformulated include: Benadryl Allergy Plus Congestion, Sudafed PE, Robitussin Peak Cold Nighttime Nasal Relief, Vicks Nyquil Severe Cold and Flu, Advil Allergy and Congestion Relief, Tylenol Cold and Flu Severe Day & Night, and more.

FDA officials reportedly presented data that claimed the drugs that use the ingredients generated $1.8 billion in 2022.

Dr. Scott Gottlieb, a board member for Pfizer, complained on X that the decision could drive up the costs of medicine for consumers.

“This is a shame. At FDA we looked closely at this question in [2005/2006] when pseudoephedrine was forced behind the counter, concluding phenylephrine was active. Now cold sufferers may have even fewer accessible options, driving up healthcare cost,” Gottlieb said.

"If FDA expands use of new path created by reform of over the counter drugs to now proactively remove established OTC drugs from market in absence of safety concerns, need a clear process and rationale for how public health is being advanced and unintended consequences mitigated," he added.

Phenylephrine was reportedly patented in 1927 and came into medical use in 1938. It was approved in the 1970s as a way to shrink blood vessels in the nose to relieve nasal and sinus congestion.

However, the FDA documents stated that there is less than 1% bioavailability of the drug after it passes through the metabolic system, "meaning that in addition to lack of an efficacious dose, an appropriate dosing interval for oral [phenylephrine] has not been established."

Simply put, when taking phenylephrine orally, the drug is rendered almost completely ineffective after it is broken down in the patient's stomach, according to the FDA review.

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