A popular drug for colds and allergies is not effective: it’s money down the drain

Phenylephrine, a popular ingredient in many over-the-counter allergy and cold medications, is not effective in tablet form, reports CNN.

Photo: IStock

On September 12, an independent advisory committee to the US Food and Drug Administration (FDA) announced this.

Phenylephrine is the main ingredient used in medications such as Benadryl Allergy Plus Congestion, Sudafed PE, and Vicks Sinex.

The ingredient is considered safe to use. But many doctors have questioned the effectiveness of phenylephrine for years. Last year alone, sales of these products totaled nearly $1,8 billion, according to the FDA.

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On September 12, the committee responded in the negative to a specific question about the drug: "Does current scientific evidence support that a typical dose of oral phenylephrine is effective as a nasal decongestant."

The vote was unanimous among its 16 members, and the committee agreed that the issue did not need further study.

“We really shouldn't have ineffective products on the market,” said committee member Dr. Diane Ginsburg of the University of Texas.

“Biography” of phenylephrine

The FDA told the committee it would take its recommendations into account, but did not give a time frame. If the agency decides to remove phenylephrine from the Generally Recognized as Safe and Effective (GRASE) category, interested parties will have the opportunity to comment on the proposed change and provide any additional data. During this process, companies will still be allowed to sell products containing phenylephrine. But if the FDA agrees with the committee, companies could be required to remove phenylephrine products from store shelves or reformulate them.

The agency approved phenylephrine for over-the-counter use in the 1970s. It became even more common after 2005, when legislation restricted access to over-the-counter medications that use a similar decongestant ingredient called pseudoephedrine.

In 2007, an FDA committee reviewed the scientific evidence available at the time and came to a different conclusion, agreeing that phenylephrine "may be effective" but also calling for more research.

Since then, research, including three large clinical trials, has shown that the orally administered ingredient is not effective as a decongestant at its typical dosage.

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The committee did not consider nasal sprays containing phenylephrine, which studies show are effective, at least temporarily.

According to the American Academy of Allergy, Asthma and Immunology, phenylephrine is considered the most common ingredient in over-the-counter nasal and sinus medications. Last year, the group supported a citizen petition to remove the drug's over-the-counter status.

Phenylephrine temporarily reduces swelling of the blood vessels in the nasal passages. A respiratory infection or allergy causes the body to send white blood cells to the nose, throat, and sinuses, causing the nasal membranes to become swollen and produce mucus. Decongestants constrict the blood vessels in the sinuses and nose, reducing swelling and helping fluid drain.

Waste of money

In tablet form, some scientists say, phenylephrine is absorbed in the intestines and metabolized so well that only a small portion of it reaches the bloodstream, where it needs to reach the nose. This is stated in a citizen's petition filed with the FDA.

A citizen petition is a way for industry, consumer groups, or individuals to petition the FDA to change regulations or take other administrative action. The committee advised the FDA to act because the pills were essentially a waste of money.

"It's amazing how many dollars are wasted on something that actually has no effectiveness," said committee member Dr. William Feig, a clinical pharmacologist and researcher at the National Cancer Institute.

Every year, many Americans turn to over-the-counter cold and allergy medications for help. According to the American Lung Association, about 60 million people in the United States have allergies, and adults get two to four colds per year, for a total of 1 billion colds per year.

Research shows that colds and allergies can have a significant impact on your quality of life. In addition to a runny nose and cough, allergies and colds can aggravate asthma and cause trouble sleeping.

Changing the label of phenylephrine can be costly for manufacturers. The Consumer Health Products Association, which represents manufacturers of over-the-counter drugs and dietary supplements and consumer medical devices, opposes the changes.

The association said Sept. 12 that it was disappointed by the committee's decision and urged the FDA, before making any regulatory changes, to "be mindful of the weight of evidence supporting this long-standing OTC ingredient, as well as the significantly negative unintended consequences that could be associated with any potential changes in regulatory status."

The company told the FDA committee that its research shows that people prefer decongestants in tablet form to nasal sprays.

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If the FDA decides to reclassify phenylephrine and it leaves the market, the agency will need to inform the public about why some popular allergy and cold medications are no longer available.

If phenylephrine is not available, there are several other over-the-counter options, including nasal sprays, antihistamines, nasal corticosteroids and nasal saline solutions, and pseudoephedrine tablets.

Pseudoephedrine products are considered over-the-counter, but in large quantities pseudoephedrine can be used to make the illegal drug methamphetamine.

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