FDA Admits Your OTC Decongestant May Not Work As Well As You Think It Does
A staple in most household medicine cabinets, many OTC decongestants contain phenylephrine to help relieve swollen, stuffy nasal passages. Yet experts have found that the drug does not appear to combat decongestion as once thought when taken in pill form, reports NBC News. In a meeting of the FDA Nonprescription Drugs Advisory Committee that took place over the course of two days from September 11 to September 12, the panel presented evidence challenging the efficacy of the medication and discussed whether its 'Generally Recognized as Safe and Effective' (GRASE) label should be reevaluated (via FDA).
Phenylephrine can be found in certain Benadryl, Sudafed, and Vicks Nyquil sinus and allergy relief products. The popularity of these products resulted in sales numbers of nearly $1.8 billion within the last year. With all members of the advisory panel in agreement that the drug is no more effective than a placebo, the FDA now has a few options to consider. This includes whether the drug's GRASE classification should be amended, whether drug manufacturers should be required to reconstruct the medication's formula, or whether phenylephrine-containing products should be done away with altogether.
Effectiveness of oral decongestants versus nasal sprays
While these findings may come as a surprise to consumers, some healthcare professionals state they've been aware of phenylephrine's ineffectiveness for quite some time now. Dr. Natalee King, a Phoenix-based pharmacist who manages Fairmont Pharmacy, told Arizona's Family, "I've been a pharmacist for 22 years and when people ask for recommendations, I've been telling them for 22 years it doesn't work." The reason being, she says, is because the drug isn't effectively absorbed into the bloodstream when taken as a tablet. However, this is not the case for phenylephrine-containing nasal sprays, which do target swollen blood vessels in the nose, Dr. King explains.
Should the FDA vote in alignment with the advisory committee, the Consumer Healthcare Products Association told NBC News that the decision could be detrimental to both drug manufacturers and consumers by limiting their congestion treatment options. Yet the advisory board highlights that there are still plenty of options available for purchase. While the timeline for when the FDA will reach a decision is currently unknown, experts emphasize that there is no question as to the safety of the drug.