Blog Common Over-The-Counter Decongestant Do Not Work: FDA Panel Says.

Common Over-The-Counter Decongestant Do Not Work: FDA Panel Says.

The advisory panel of the Food and Drug Administration declared over the week that phenylephrine does not work well. The decongestant is a part of medications for cold and allergies. 

A unanimous vote declared the oral formulation of the medication ineffective against nasal congestion. This declaration may lead to disruption of the market for OTC allergy and cold medications. A large number of the population prefers pills over nasal sprays which is threatened by the declaration. 

Drawing sales of nearly $2 billion USD last year, phenylephrine is the most popular decongestant in the country. The FDA officials shared the data during the meeting, saying it is found in most medications such as Sudafed PE, and Benadryl Allergy Plus Congestion. 

The mechanism of its action is known to be through reducing the swelling in blood vessels present in the nasal passages. The unanimous vote of the panel reflected the evidence against the medication by FDA. Its evidence suggests that the ineffectiveness of the medication is prominent when it is taken in the oral form. 

The reason for it was found to be a low amount of the medication reaching the nose, which defeats the purpose of the medication. This suggested the use of nasal sprays over tablets. 

Susan Blalock, a member of the advisory committee and a retired professor of Pharmacy in North Carolina, said that the evidence was “pretty compelling.” She added further that the evidence against the effectiveness of the medication does not need additional data. 

The designation of the OTC might be revoked due to the evidence presented this week. FDA added that the older drugs were given the designation “generally recognized as safe and effective.” This designation allowed the manufacturers of OTC drugs to not fill an FDA approval form before including an ingredient. 

The removal of the designation will lead to the removal of the drug from the drugstores, forcing drugmakers to develop new formulations. 

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