*According to the Food and Drug Administration, most over-the-counter decongestants are ineffective.
The 16-member Nonprescription Drug Advisory panel found that after a 2-day review, phenylephrine, the active ingredient in Sudafed, Benadryl, Robitussin, and other popular decongestants, “is not effective” at reducing nasal congestion, Daily Mail reports.
“This drug and this oral dose should have been removed from the market a long time ago,” Jennifer Schwartzott, a patient advocate from New York, told NBC News.
Companies may be forced to withdraw or reformulate their products as a result of their ruling. The panel’s unanimous vote only applies to oral formulations of phenylephrine.
Nearly every nasal decongestant on pharmacy shelves contains phenylephrine. FDA officials presented data recently showing that drugs containing it generated almost $1.8 billion in sales last year.
“The patient community requires and deserves medications that treat their symptoms safely and effectively and I don’t believe that this medication does,” Schwartzott added.
According to MedPage Today, the FDA began investigating oral phenylephrine in 2007 after pharmacy professors at the University of Florida launched calling for the agency to review whether a 10-milligram phenylephrine pill worked as a decongestant.
“In conclusion, we do believe that the original studies were methodologically unsound and do not match today’s standard,” said Dr. Peter Starke, an FDA official who led the review of phenylephrine. “By contrast, we believe the new data are credible and do not provide evidence that oral phenylephrine is effective as a nasal decongestant.”
Despite widespread belief that the medication is not very helpful, there is no substantial evidence that it poses a safety risk.
“We think the evidence supports that phenylephrine’s status as a safe and effective over-the-counter product should be changed,” said Dr. Randy Hatton, a pharmacy professor at the University of Florida and co-author of the petition, per the Daily Mail.
“We are looking out for the consumer, and he or she needs to know that science says that oral phenylephrine does not work for the majority of people,” Hatton added.
“Scientific evidence continues to show that the most popular products on the market containing phenylephrine are ineffective,” Dr Leslie Hendeles, a pharmacotherapy professor and co-author of the UF petition, said in 2015, per Daily Mail.
“Patients who seek an over-the-counter remedy should get what they pay for: an effective and safe alternative to a prescription drug.”
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