Beyond Local: An FDA advisory panel concludes that oral phenylephrine is ineffective, meaning consumers need to think carefully when purchasing cold and flu medicines.

The following article, written by Lucas A. Berenbrok, University of Pittsburgh; Colleen Culley, University of Pittsburgh and Karen Steinmetz Pater, University of Pittsburgh, first appeared on The Conversation and is published here with permission:

The onset of cold and flu season is a terrible time for consumers to learn that some of the most reliable purchaseable products actually don’t work.

A U.S. Food and Drug Administration advisory committee unanimously concluded in September 2023 that phenylephrine Severe Cold and Flu, the active ingredient found in popular over-the-counter cough and cold products such as Sudafed PE, Theraflu, and NyQuil Severe Cold and Flu, is no better. Placebo when taken orally FDA 2023 Advisory Panel meets to review growing evidence that oral phenylephrine is ineffective for treating nasal congestion. The committee did not review the effectiveness of phenylephrine nasal spray.

In response, CVS, one of America’s largest drugstore chains, announced that it would no longer sell products containing oral phenylephrine, the only active ingredient, in community pharmacies.

For the millions of Americans who will be sick with colds and stuffy noses this fall and winter. Many of whom have used products containing phenylephrine for many years. The panel’s decision may be shocking.

Consumers are likely wondering whether they should stop using over-the-counter products that contain phenylephrine. Will the product still be on shelves this winter? And there may be other options. Consumers may question whether combined cough, cold, and flu products will remain safe and effective for use at home.

As the FDA considers the advisory committee’s conclusions, Oral phenylephrine will continue to be sold in many pharmacies. This is despite the fact that over-the-counter medications and non-drug treatments are more effective at relieving congestion.

As a pharmacist who focuses on patient care in the local community We have suggestions for what to do when you need relief from cold and flu symptoms.

The story behind

As of fall 2023, phenylephrine is listed as the sole or one of the active ingredients in thousands of over-the-counter products, including tablets, liquids, nasal sprays, gels. and wax

This medicine when taken in pill form. oral fluid or nasal spray It has long been used to relieve sinus or nasal congestion from the common cold or seasonal allergies. Phenylephrine is the only oral decongestant available at pharmacies and grocery stores. Since another popular drug, pseudoephedrine, It became more regulated and stopped being sold behind the counter in 2006.

The latest analysis is not the first time that an FDA advisory panel has examined oral phenylephrine in detail. A panel reviewing its use in 2007 concluded that further studies are needed to make a final decision on phenylephrine’s effectiveness.

Further studies since then have found no difference in efficacy between phenylephrine and placebo. This may be because phenylephrine taken orally is deactivated in the intestines.

Safety concerns

No safety concerns were found with oral phenylephrine alone in the 2023 advisory panel’s conclusions. However, researchers and advisory panel members raised concerns about the feasibility of products containing phenylephrine. Ineffective Nilephrine Remaining on Pharmacy Shelves

Although oral phenylephrine is safe, But using ineffective drugs can cause consumers to waste money on products that are no better than placebos. The placebo effect is a well-known phenomenon in which people consuming an inactive product may perceive benefits. Placebo pills used in the study phenylephrine Have the same or similar shape and color as pellets. phenylephrine But there is no active ingredient.

The panel also noted a missed opportunity for pharmacists to recommend more effective products for nasal congestion. If phenylephrine is still available on the market

Despite the advisory committee’s conclusions, FDA has not taken official action as of late October 2023 if the agency proposes changes to phenylephrine availability. Consumers will be asked to weigh in before a final verdict is made.

The Story Behind Pseudoephedrine

Fortunately, there are over-the-counter oral decongestants such as pseudoephedrine. which is known to be effective It has been available on the market for many years. This medicine is available as a single ingredient product or in combination with other ingredients. in products marketed to treat nasal congestion

Pseudoephedrine It is a decongestant that is taken by mouth to relieve nasal congestion. It works by constricting blood vessels that have become enlarged as a result of the common cold, the flu, or seasonal allergies.

But purchasing products containing pseudoephedrine is not as straightforward as it may seem. Because pseudoephedrine can be used to make street methamphetamine, the FDA requires it to be sold over the counter with daily and monthly quantities limited. Photo identification is also required at the point of sale.

If the FDA acts on the advisory committee’s conclusion that oral phenylephrine is not an effective nasal decongestant, Pseudoephedrine may be the only oral medication remaining without a prescription to treat nasal congestion. Here are some things to know about pseudoephedrine:

• Pseudoephedrine should not be used in higher doses than recommended on the label. The use of products containing pseudoephedrine should be discontinued. And if you experience dizziness, irritability, or insomnia You should consult your health care provider.

• Pseudoephedrine should not be used by consumers with heart disease. high blood pressure Thyroid disease, diabetes, or enlarged prostate without consulting with a health care provider such as a pharmacist or doctor

• Products containing pseudoephedrine should not be used while taking a monoamine oxidase inhibitor or within two weeks of stopping the medicine. This is often used to treat depression or Parkinson’s disease.

Other treatments

In addition to oral pseudoephedrine, Nasal spray medicine This includes medicines that contain phenylephrine or oxymetazoline as ingredients. It also helps relieve nasal congestion. These products are sold under the brand name Afrin and others.

However, medication isn’t the only way to relieve a stuffy nose. Some non-drug methods include taking a hot, steamy bath. Using a neti pot safely Steam vaporizer or humidifier Saline nasal spray and applying a warm, damp washcloth to the face. These non-drug methods can help relieve congestion and provide temporary relief from nasal congestion. If nasal congestion lasts longer than two weeks or signs of infection appear, see a doctor.

This is because oral phenylephrine-containing products will remain on the market at this time. It is therefore important for consumers to read the labels of over-the-counter products. and examine the active ingredients and risks.

You should consult your pharmacist about your symptoms. Your medical condition and other medications you are taking before purchasing an over-the-counter product. Your pharmacist will help you determine whether your symptoms can be managed with self-care or if you need to see a doctor.

Lucas A. Berenbrok, Associate Professor of Pharmacy and Therapeutics University of Pittsburgh; Colleen Culley, Associate Professor of Pharmacy University of Pittsburghand Karen Steinmetz Pater, associate professor of pharmacy. University of Pittsburgh

This article is republished from The Conversation under a Creative Commons license. Read the original article.