FDA Deems Phenylephrine ‘Ineffective’

Phenylephrine, the mainstay in many OTC nasal decongestant preparations such as Dayquil and Sudafed, and some nasal sprays, was recently deemed by the FDA as “ineffective.”  

When the product originally came to market, the scientific standards for drug approvals were not what they are now for new medications being approved. However, its true effectiveness has been questioned for decades. The advisory is only for the oral preparation of phenylephrine and not the topical nasal sprays.  

Recommended course: Cough, Cold and Fever Symptoms: Pharmacologic Therapies 

The FDA uses the GRASE acronym: Generally Recognized As Safe and Effective, a legal term used when considering the ingredients in older OTC drugs that no longer need oversight by the FDA in order to be sold. It now remains to be seen if the FDA makes the decision to remove products containing phenylephrine from the shelves. 

Pseudoephedrine and the Combat Methamphetamine Act 

Pseudoephedrine, a common yet highly effective nasal decongestant, came under fire In 2005 after the Combat Methamphetamine Act came into play, limiting consumer access to the drug. The restriction came about due to the use of pseudoephedrine in illicit manufacturing of methamphetamines.  

The Act requires pharmacies and retail organizations to keep track of how many products containing pseudoephedrine can be purchased by an individual in any given day. It is now relegated to behind the counter use and by request only after personal identification has been verified. It was after this Act came into place that phenylephrine became more widely available. 

The FDA however, does state that the OTC dose of phenylephrine is safe and for some people, there may be the benefit of relief of nasal congestion when combined with other ingredients. There is a monograph used to determine if the medication is not effective, the agency can issue an order to have the ingredient removed thereby losing the GRASE status. Once that occurs, the FDA then works with manufacturers in reformulating products. 

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