FDA Advisers Say Cold Medicines and Decongestants Are Ineffective

After reviewing the evidence, the Nonprescription Drugs Advisory Committee determined that phenylephrine, a popular ingredient in many cold, flu, and allergy medications, does not relieve nasal congestion.

On September 12, a 16-member independent advisory committee to the FDA determined that phenylephrine — a popular ingredient in many over-the-counter (OTC) cold medicines — is ineffective at relieving nasal symptoms such as stuffiness or congestion.

The Nonprescription Drugs Advisory Committee (NDAC) voted that decongestants are ineffective based on recent research, including three comprehensive clinical trials that found no differences between phenylephrine and a placebo in nasal congestion relief.

However, the committee did not look at nasal sprays containing phenylephrine, which some studies suggest may temporarily relieve nasal symptoms.

Phenylephrine became the primary ingredient in OTC allergy, cold, and flu medications after a 2006 law removed pseudoephedrine from store shelves. Pseudoephedrine is an older decongestant that can be processed into methamphetamine. Although the drug is still available, consumers must ask a pharmacist for access as it's kept behind the counter.

The advisory committee notes that phenylephrine's effectiveness was the topic of debate, not the drug's safety. Still, ineffective decongestants could be a safety issue if using them delays the treatment of more severe nasal conditions such as chronic sinusitis.

During post-vote discussions, committee member Stephen Clement of Inova Medical Group explained, "Poor efficacy really is a safety issue for delayed treatment. So, this is not just 'well, it's not doing anything bad, so why not just continue it' — it is a safety issue because the patients are being given the wrong thing, and it's preventing them from getting the right thing."

Committee member Jennifer Schwartzott, a patient representative from New York, adds, "I feel that this drug in this oral dose should have been removed from the market a long time ago. The patient community requires and deserves medications that treat their symptoms safely and effectively. And I don't believe that this medication does that."

The FDA will consider the committee's advice and decide whether to take action. However, it's unknown when that might occur. Still, if the agency agrees with the committee's vote, manufacturers that include phenylephrine in their allergy, cold, and flu medications may be required to reformulate their products or remove them from retailer's shelves.

Which cold, flu, and allergy medications contain phenylephrine?

According to a Forbes report, some of the more commonly used OTC medications that contain phenylephrine include Benadryl Allergy Plus Congestion, Mucinex Cold and Flu, Sudafed PE, DayQuil and NyQuil Severe Cold and Flu, Tylenol Sinus and Headache, Tylenol Cold and Flu, Robitussin Cough and Allergy, and Advil Cold and Flu. In addition, many drugstores and retailers offer generic versions of phenylephrine.

Although the NDAC agrees that decongestants are ineffective, nasal sprays containing phenylephrine may still offer temporary relief from nasal symptoms.

Besides decongestants, drinking plenty of fluids, running a humidifier, or using saline nasal sprays can also help relieve nasal stuffiness.

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