FDA Panel Announces Oral Phenylephrine Doesn’t Work, Here Are the Alternatives

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When used as an oral decongestant, phenylephrine, a common ingredients in over-the counter cold medicines, is ineffective, the U.S. Food and Drug Administration unanimously ruled after a two-day review.

Should the FDA officials follow the recommendation of the advisory panel to pull phenylephrine’s GRASE (generally recognized as safe and effective) designation, drugs that include it, such as Sudafed PE, Mucinex Sinus-Max, Benadryl Allergy Plus Congestion, and Tylenol Cold+Head, may become unavailable. Manufacturers may choose to reformulate medications that include phenylephrine, a move that may bring significant financial burdens.

It may take several months before the FDA makes a final determination on removing phenylephrine from the market.

The main problem is that when taken orally, phenylephrine undergoes metabolism in the gut. This significantly diminishes the amount that ultimately enters the bloodstream, leaving only a fraction insufficient to alleviate congestion.

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“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine, told the Associated Press.

Phenylephrine became the common ingredient in OTC decongestants after a 2006 law restricted pseudoephedrine sales to behind pharmacy counters to combat methamphetamine production.

The Decision Doesn’t Mean Drug is Harmful

The panel discussed implications for consumers. There is now significant potential for consumer concern, given the recommendation to remove phenylephrine from the market after years of availability, according to Diane Ginsburg from the University of Texas at Austin College of Pharmacy.

Chief among those concerns will be consumer fears that the panel’s decision implies potential harm associated with the drug.

It will be important to communicate reassurances to patients who still have these products, she said. “Patients need to know for certain that ”harm will definitely not come to them,“ she added. ”That reassurance is going to be absolutely critical.”

There Are Effective Forms of Phenylephrine Available

While the FDA found oral phenylephrine ineffective, nasal sprays and drops containing the drug are still considered effective decongestants.

This provides an option for those accustomed to phenylephrine products.

These OTC decongestants include:

• Neo-Synephrine
• Nostril
• Pretz-D
• Rhinall
• Tur-Bi-Cal
• Vicks Sinex

Alternative Ways to Relieve Nasal Congestion

Effective congestion relief doesn’t have to require pharmaceutical drugs.

Four natural, research-supported alternatives for clearing nasal congestion are:

1. Nettles

Nettles are a natural alternative to decongestants like phenylephrine. Nettles contain histamines, which can help to reduce inflammation and congestion in the nasal passages. Nettle leaves can be brewed into a tea or taken in supplement form.

2. Saline nasal spray

Saline nasal sprays are a simple and effective way to clear nasal congestion. Saline spray is made up of saltwater, which can help to soothe irritated nasal passages and loosen mucus.

3. Steam

Steam inhalation is another effective way to relieve nasal congestion. Breathing in steam helps moisturize and open nasal passages. Options for steam therapy include taking a hot shower, using a humidifier, or placing a towel over your head and inhaling steam from a bowl of hot water.

4. Lavender oil

Lavender oil has been shown to have anti-inflammatory properties that can help decrease nasal congestion. Lavender oil can be diffused into the air or applied topically to the chest or neck.