The Food and Drug Administration (FDA) will seek public opinion before finalizing its decision to remove an ingredient from over-the-counter (OTC) medications like Sudafed and Benadryl that doesn’t work.
The agency announced the clarification Thursday after a panel of outside experts unanimously decided that the ingredient phenylephrine, commonly used in cold and cough syrups, is ineffective.
If the FDA agrees with the panel’s position, it will propose removing phenylephrine from the list of ingredients allowed in over-the-counter drugs and seek public comment on it.
After reviewing public comments, if the FDA still agrees that phenylephrine does not work, it will issue a final order and work with manufacturers to reformulate products to effectively treat cold or allergy symptoms.
The FDA has not specified how it will gauge public opinion.
The ingredient phenylephrine is common on pharmacy shelves and has been designated generally safe by the FDA. But losing that designation could mean major players in the over-the-counter drug space will pull their products from shelves or formulate a new formula
Phenylephrine is ubiquitous, so much so that almost every nasal decongestant on pharmacy shelves contains it
The ingredient is protected under the FDA’s GRASE (General Recognized as Safe and Effective) designation, but a recall of the approval could require manufacturers including Bayer, Johnson and Johnson to reformulate the formula.
Phenylephrine is ubiquitous, so much so that almost every nasal decongestant on pharmacy shelves contains it.
Drugs containing it generated nearly $1.8 billion in sales last year, according to data presented Monday by FDA officials.
A unanimous vote by the 16-member Nonprescription Drug Advisory panel could be a major blow to the industry.
The FDA’s ruling applies only to oral formulations of phenylephrine.
If the agency decides to revoke the GRASE designation for oral phenylephrine, major manufacturers of drugs like Sudafed PE and Benadryl could be forced to reformulate them.
Phenylephrine was approved by the FDA in the 1970s to shrink dilated blood vessels in the nose, relieving nasal and sinus congestion.
But since then, more research has emerged questioning whether oral formulations of the drug have any measurable benefit, given how it is metabolized in the body.
The drug is metabolized in the intestines, with only a fraction entering the bloodstream and reaching the nose.
In fact, briefing documents compiled by the FDA show that a concentration of less than one percent of the drug can reach the nose after being broken down in the intestines.
The documents detail shortcomings in studies of the ingredient in the 1960s and 1970s, which cited small sample sizes and relied on techniques no longer used by the FDA to approve drugs.
The unanimous ruling does not include another popular decongestant, pseudoephedrine.
In 2006, a law was passed to restrict access to pseudoephedrine, the active ingredient in many versions of Sudafed, by moving it behind the counters of pharmacies.
The ingredient is used to illegally process methamphetamine.
The original Sudafed, which contains pseudoephedrine, is less popular than versions that don’t require a trip to the pharmacy, and American consumers largely prefer pills to nasal sprays.
Phenylephrine seems to work better when applied directly to the nose.
In 2007, pharmacy professors at the University of Florida filed a petition urging the FDA to investigate whether a 10-milligram phenylephrine pill worked as a decongestant.
They said in a meta-analysis of available data: ‘Thus, the results of the studies reported after the 2007 Advisory Committee meeting clearly demonstrate that (phenylephrine) is no more effective than placebo in reducing nasal congestion and that quadrupling the dose did not provide results. extra advantage.’
Since then, a series of studies have emerged pointing to its ineffectiveness.
In 2015, a study sponsored in part by New Jersey-based pharmaceutical company Merck & Co found that the 10-milligram dose, as well as the 20, 30, or 40-milligram doses, “were not significantly better than placebo in relieving stuffy nose’. ‘ in a sample of 539 adults.