There’s an ongoing joke in my family about a popular over-the-counter cold medication. When someone gets a cold, we often use this medication for symptom control. But then we laughingly say, “I’m not sure if this really works, or if it’s the amount of alcohol in it that it makes you not care.”
Despite the joking, cold season after cold season I go to the drug store and purchase this time-honored cold medication. Last week, however, an advisory committee of the Food and Drug Administration (FDA) stated that oral phenylephrine is not effective as a decongestant and are recommending that it be removed from the Generally Recognized as Safe and Effective (GRASE) list of medications. It has made me wonder if our family joke is truer than we thought.
When you have a respiratory infection or allergies, the body sends white blood cells and other immune products into the nose, causing swelling and mucus creation. Decongestants work by constricting the blood vessels in the nasal passages, thus reducing the swelling and creation of mucus. Phenylephrine as a nasal spray works very well as a decongestant. But there has always been some controversy about how well it works orally.
Oral phenylephrine was approved for over-the-counter use in the 1970’s, but because of the controversy about how well it works, it didn’t become common in over-the-counter cold and allergy medications until 2005. That was the year that many manufacturers removed pseudoephedrine from cold and allergy products because the FDA required medications that contained pseudoephedrine to be moved “behind the counter” at pharmacies. That move was made because pseudoephedrine can be used to make methamphetamine.
Moving pseudoephedrine products behind the counter decreased sales, and manufacturers responded by adding phenylephrine instead to cold and allergy products. In 2007, the FDA looked at the research on phenylephrine and said the drug “may be effective” and called for more research. More than a decade of research later, including three large clinical studies, the research found that orally administered phenylephrine is not effective. The reason is because in the case of oral phenylephrine, the digestive system is very good at destroying the drug. That means very little of the medication gets into the blood stream where it can work to constrict nasal blood vessels.
If the FDA takes the advisory committee’s advice and removes oral phenylephrine from the GRASE list, that will mean manufacturers will have to remove it from their products. In 2005, the change in rules for oral decongestants was a big issue for manufacturers. Today it will be even more so because there is not another oral decongestant other than the no-prescription required but still “behind the counter” pseudoephedrine.
The over-the-counter cold and allergy product market is significant. According to the American Lung Association, about 60 million people in the U.S. suffer from allergies.
The average adult gets 2-4 colds each year which works out to 1 billion colds in the U.S. each year. Consumer surveys show that people prefer using oral decongestants over nasal sprays. Cold and allergy symptoms have a negative effect on quality of life. They can also aggravate asthma and reduce restful sleep.
Knowing those facts, it’s easy to understand how over-the-counter cold and allergy symptom reliving products that contain oral decongestants are very important to manufacturers and the public. The Consumer Healthcare Products Association, which represents manufacturers of over-the-counter medications, dietary supplements, and consumer medical devices, is opposed to removing phenylephrine from over-the-counter cold and allergy medications. They have encouraged the FDA to be mindful of the totality of the evidence supporting phenylephrine and to be mindful of the significantly negative unintended consequences that will occur from removing phenylephrine from over-the counter cold and allergy products.
The FDA has not decided about oral phenylephrine, nor has it said when it will. Until then, if there is a product that works for you and is okay with your primary health care provider, keep using it. But, if you do feel like the product(s) you are using are ineffective, please speak to your primary health care provider about “behind the counter” and/or prescription products that may be more effective. Cold and allergy symptoms can be reduced and/or eliminated using other products than phenylephrine, and your primary health care provider can help you find the best one for you.
