A U.S. Food and Drug Administration advisory panel concluded Tuesday that phenylephrine, a key ingredient in many over-the-counter cold and allergy medicines, is not effective in clearing nasal congestion.
The unanimous vote unequivocally declaring that oral formulations of phenylephrine are ineffective is expected to disrupt the market for OTC cold and allergy medicines, where consumers primarily prefer tablets to nasal sprays.
Phenylephrine, found in drugs such as Sudafed PE, Vicks Synex, and Benadryl Allergy Plus Congestion, is the most popular oral decongestant in the United States, with sales of about $1.8 billion last year. According to data released Monday by FDA officials.
This drug is thought to relieve nasal congestion by reducing the swelling of blood vessels in the nasal passages.
Committee vote reflects damning evidence Provided by FDA The researchers found that when phenylephrine is taken orally, a very small amount of the drug actually reaches the nose and relieves nasal congestion.
Susan Blalock, a former professor and advisory board member at the UNC Eshelman School of Pharmacy in North Carolina, said the evidence is “pretty convincing that this drug is ineffective. Additional data is needed to support that conclusion.” I don’t think it’s necessary.” ”
The FDA will now have to decide whether to revoke the drug’s OTC designation, saying it is “generally recognized to be safe and effective.”of designationis typically used in older drugs and allows drug companies to include the ingredient in OTC products without filing an FDA application.
Without a designation, products containing the ingredient may have to be removed from store shelves or manufacturers may have to develop new formulations. An FDA spokesperson declined to say when the agency would make a final decision. The FDA typically sits on advisory committees.
“This drug and this oral dose should have been removed from the market a long time ago,” said Jennifer Schwartzott, a New York patient representative. “The patient community needs and deserves a drug that safely and effectively treats their symptoms, and I do not believe this drug does that.”
Phenylephrine gained popularity in the early 2000s as an alternative to pseudoephedrine, a nasal decongestant used in Sudafed. Moved behind the pharmacy counter In 2006, in an attempt to curb its misuse as a raw material for methamphetamine production.
At the two-day conference, FDA scientists presented the results of five studies conducted over the past 20 years on the effectiveness of oral phenylephrine. All studies concluded that decongestants were as effective as a placebo.
They also reevaluated the initial findings used to support OTC use. The agency found that the results were inconsistent, did not meet modern standards for study design, and there may have been data integrity issues.
“In conclusion, we believe that the original study was methodologically unsound and does not meet today’s standards. In contrast, we believe that the new data are reliable and that oral phenylephrine “We believe that it does not provide evidence that it is effective as a nasal decongestant,” said Dr. Peter Stark, the FDA official who led the review of phenylephrine.
The concerns go beyond inefficiency. Phenylephrine may have side effects such as headache, insomnia, and nervousness. High doses may increase blood pressure.
The committee does not question the effectiveness of nasal spray phenylephrine, which is still thought to provide temporary relief from nasal congestion.
Representatives from the Consumer Healthcare Products Association, a group representing over-the-counter drug manufacturers, did not present any new evidence in a presentation Monday to refute the FDA’s claim that the drug is ineffective.
The group instead said that if oral phenylephrine was not available over-the-counter, it would be a significant burden for consumers.
The group shared findings that one in two U.S. households used an oral nasal decongestant in the last year. It was also found that people preferred oral nasal decongestants to nasal sprays by a ratio of 3 to 1.
The group also said other effective alternatives would not be so easily available, a claim disputed by advisory committee members.
“We have an effective alternative to pseudoephedrine,” said Dr. Marian Amirshahi, a committee member and professor of emergency medicine at Georgetown University School of Medicine, referring to the ingredients found in Sudafed. “The bar for this product is not as high as described.”
Patients who wish to purchase Sudafed should ask their pharmacist.
