A recent decision by a Food and Drug Administration advisory panel has revealed that phenylephrine, a key ingredient in many over-the-counter cold and allergy medications, is ineffective in relieving nasal congestion. This unanimous vote specifically targeted oral formulations of phenylephrine, which are popular among consumers who prefer pills over nasal sprays.
Phenylephrine, found in various drugs like Sudafed PE and Vicks Nyquil Sinex Nighttime Sinus Relief, generated approximately $1.8 billion in sales last year in the United States. The drug is believed to reduce nasal congestion by reducing swelling in blood vessels in the nasal passages.
The advisory panel’s decision aligns with evidence provided by the FDA, which concluded that only a small amount of phenylephrine reaches the nose to relieve congestion when taken orally. Experts, such as Susan Blalock, a retired professor at the UNC Eshelman School of Pharmacy and an advisory committee member, find the evidence overwhelmingly supports the ineffectiveness of this medication.
Now, the FDA must decide whether to revoke phenylephrine’s designation as “generally recognized as safe and effective” for over-the-counter use. This designation allows drugmakers to include the ingredient in OTC products without FDA approval. If revoked, products containing phenylephrine may need to be removed from store shelves, prompting manufacturers to develop new formulations. The FDA has yet to announce its final decision, but it typically follows the recommendations of its advisory committees.
Jennifer Schwartzott, a patient representative from New York, emphasizes the need for safe and effective medications to treat symptoms and believes that phenylephrine does not meet these requirements. She argues that this drug should have been removed from the market long ago.
Phenylephrine gained popularity in the early 2000s as a replacement for pseudoephedrine, which was moved behind the pharmacy counter in 2006 to combat its misuse in making methamphetamine.
During a two-day meeting, FDA scientists presented the results of five studies conducted over the past two decades, all concluding that oral phenylephrine is no more effective than a placebo. The initial findings supporting its OTC use were also re-evaluated and found to be inconsistent and unreliable.
Concerns go beyond the drug’s ineffectiveness; phenylephrine can cause side effects like headaches, insomnia, and nervousness and may increase blood pressure at higher doses. However, the panel is not disputing the effectiveness of nasal spray phenylephrine in providing temporary relief from congestion.
Representatives for the Consumer Healthcare Products Association, which represents OTC drug manufacturers, did not present any counter evidence to the FDA’s claims during their presentation. Instead, they argued that removing oral phenylephrine from the market would burden consumers. However, a survey conducted by the group revealed that 1 in 2 households in the U.S. used an oral decongestant in the last year, and people prefer oral decongestants over nasal sprays by a margin of 3 to 1.
Committee member Dr. Maryann Amirshahi, a professor of emergency medicine at Georgetown University School of Medicine, disputes the claim that effective alternatives are not readily accessible. She suggests that pseudoephedrine, found in Sudafed, is an effective alternative, albeit with the requirement to request it from a pharmacist.
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