FDA proposes removing oral phenylephrine from nasal decongestants
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Key takeaways:
- An FDA review found that oral phenylephrine is not effective in treating nasal congestion.
- The proposal is based on the drug’s efficacy, not its safety.
- The FDA is now seeking public comment on the proposal.
The FDA has proposed an order for the removal of oral phenylephrine as an active ingredient from over-the-counter monograph drug products for relieving nasal congestion, according to an administration press release.
The proposal follows an FDA review that found that oral phenylephrine is not effective in treating nasal congestion. The FDA noted that this proposal is based on the efficacy of oral phenylephrine and not on its safety.
The review included all available data on oral phenylephrine, including data from 30 years ago indicating that it was effective in nasal decongestion, in addition to newer clinical data.
Last September, the FDA’s Nonprescription Drug Advisory Committee unanimously said the current data do not support recommended dosages in the OTC cold, cough, allergy, bronchodilator and anti-asthmatic products monograph for effective nasal decongestion.
Some OTC monograph drug products only include oral phenylephrine as a single, active ingredient, the FDA said, whereas others use oral phenylephrine and another active ingredient such as acetaminophen or dextromethorphan.
Oral phenylephrine does not affect how other active ingredients in these products work to treat the symptoms they are designed to alleviate, the FDA continued.
Companies can continue to market these products as nasal decongestants, the FDA said, with different products sold under the same brand name. The FDA advised consumers to read the Drug Facts label on these products to ascertain their ingredients and to be aware of important warnings and directions for their use.
Further, the FDA noted that this proposal only applies to oral phenylephrine and not to phenylephrine in nasal sprays marketed to treat congestion.
“Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold,” Theresa Michelle, MD, director of the Office of Nonprescription Drug Products at the FDA’s Center for Drug Evaluation and Research, said in the press release.
“Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms,” Michelle said.
The proposed order is available online, the FDA said, and public comments are welcome. If the FDA issues a final order removing oral phenylephrine from the OTC monograph after reviewing these comments, it said that it will provide appropriate time for manufacturers to reformulate their products or remove them from the market.
Perspective
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I agree with this proposal, as this has been something long known by allergists across the country.
This removal would not impact how I treat patients, as I never use or recommend these products, but it may create a shift for consumers who have been used to buying them in the past. Really, it is just removing an ineffective option. It may prompt patients to seek advice from a medical professional as well, which could be helpful to them.
There are several alternatives for these patients, depending on what the dominant symptoms and source of symptoms are. These include intranasal steroids, antihistamines, and anticholinergics. Please see advice from your doctor on what may be best for you. Also, seek answers as to the root cause of your congestion.
I am hopeful that the FDA reviews diphenhydramine next as to its effectiveness in light of its side effect profile and newer medications available. I think it should be removed from the OTC market too.
Perspective
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I agree with the FDA on taking steps toward removing oral phenylephrine from the market. Currently, the evidence shows that oral phenylephrine is not better than placebo at treating nasal congestion. It is still effective when used as a nasal spray, however.
As a physician, I support treatments where the benefits outweigh the known and potential risks. Oral phenylephrine, while there are not significant safety concerns, clearly is not helpful.
There will be a period of confusion for people looking for cold medicines. However, in time, people will adjust to this medication being removed.
Phenylephrine will still be available in the form of a nasal spray, but it should not be used too frequently because it can cause a rebound nasal congestion effect known as rhinitis medicamentosa. Pseudoephedrine, also known as Sudafed (Johnson & Johnson), which is sold behind the counter, will still be available as an effective oral decongestant. Saline drops, sprays and irrigation devices can be helpful as well.
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