Oral phenylephrine, a popular OTC medicine for colds and allergies, doesn’t work

People who suffer from the common cold or the effects of allergies recently got a surprise about some of their favorite over-the-counter (OTC) medications. In September 2023, a government agency indicated they would take action soon after research showed that oral phenylephrine, a popular OTC medicine for colds and allergies, doesn’t work.

Consumers have the right to be protected from false claims so they don’t waste their hard-earned money on ineffective or even dangerous substances. Our Chicago defective product lawyers are available to help you if you feel you have been harmed by a drug that did not work as advertised or intended.

oral phenylephrine

More about the government announcement

The United States Food and Drug Administration (FDA) received a 16-0 vote from an advisory panel showing that phenylephrine, commonly used in orally administered nasal decongestants, does not work. It’s ineffective in combatting symptoms and no better than taking nothing at all.

Used in medicines like Benadryl, Sudafed, NyQuil, DayQuil, and Mucinex, phenylephrine was heavily marketed as an essential part of these multi-symptom products. It’s been in use for over six decades, and many people consider their medicine cabinets incomplete without them.

However, the FDA panel’s vote means the agency will need to decide whether to require manufacturers to remove the ingredient from their products.

So, phenylephrine doesn’t work at all?

Phenylephrine was “grandfathered” in as one of many drugs when the FDA created a list of approved drugs available over the counter in pharmacies. According to an interview with a professor of otolaryngology at Boston University published in The Brink, phenylephrine does work as a decongestant when sprayed into the nose.

However, it should only be used that way, and it is still not as effective as other drugs. It also only works for short-term use. So, does phenylephrine work? The short answer is, “Not really.”

How does phenylephrine work?

When taken orally in medicines like NyQuil, the substance does nothing to reduce the flow of blood to the vessels in the nose. Congestion occurs when the body reacts to allergens or cold viruses by rushing blood to the nose, causing the tissues there to swell. This causes your stuffy, runny nose during cold and allergy season.

If you use a spray decongestant containing phenylephrine, it would have a temporary effect, but when you swallow the medicine instead, you get no relief. Therefore, when you take it by mouth as part of a multi-symptom OTC medication, you may as well be drinking water to combat your congestion.

Will the FDA take phenylephrine off the shelves?

What the FDA will do about this decision by its advisory panel remains to be seen. Removing all products using these ingredients off the shelves would cause economic damage to the companies manufacturing and selling these products. Annual sales for these medicines are over $1.8 billion. This must be balanced against the revelation that the drug does not do what it claims.

The increase in companies using phenylephrine came in the mid-2000s when pseudoephedrine, another decongestant, was moved behind the counter. Many people were purchasing Sudafed, which contains pseudoephedrine, in large quantities to manufacture the illegal drug methamphetamine. The Combat Methamphetamine Epidemic Act of 2005 (CMEA) was passed to require consumers to show identification to the pharmacist to buy Sudafed, reducing the chance it would be used for illicit reasons.

The FDA usually follows recommendations from its advisory committees. While phenylephrine may currently be listed as safe for use, the ruling that it is not effective means the administration will likely work with manufacturers to help them reformulate their products with other decongestant substances. They will allow public comment on the decision before they move forward with any action.

Understanding more about defective products takes skilled legal guidance

If you or a loved one has been harmed by a defective drug or other product, you may have questions about what to do next. Can you sue for injury or illness? Does the manufacturer, distributor, or seller owe you compensation? When you schedule a free consultation with a Chicago defective product attorney at Horwitz, Horwitz & Associates, we will educate you on your options and how to proceed.

We have a strong record of success representing those in need and protecting their rights. Our team of attorneys and legal professionals is ready to listen to your story and develop your case using medical records, manufacturing documentation, and other evidence supporting a claim for damages. We are not afraid of big corporations and will fight fiercely to protect your interests.

Learn more about the FDA ruling on phenylephrine or any other product you have been negatively affected by using. Contact us by calling (800) 985-1819 or using our convenient online form to schedule your free case evaluation with an experienced personal injury lawyer today.

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