Survey: 90% of Patients Are Concerned About Effectiveness of Cold and Cough Ingredients

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The FDA revisited the use of phenylephrine in OTC medications and called for more substantial evidence supporting its efficacy when taken orally.

Approximately 90% of individuals are concerned that cold and cough medications could have ingredients that are ineffective, according to a study conducted by Diabetic Tussin. In a press release, the results indicated that over half of patients go to the pharmacy to find advice on cold and flu solutions.1

Young woman with fever and headache is measuring temperature with thermometer, treated at home. Winter cold and flu concept. | Image Credit: Monstar Studio - stock.adobe.com

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"As we approach the peak of cold and flu season, there is a heightened desire for effective and reliable treatment options that can provide multi-symptom relief with the right ingredients," Randi Jachino, vice president of marketing at Prestige Consumer Healthcare, said in a press release.1

The study included approximately 2000 adults aged 18 and older in the United States, according to the press release. They were contacted via an online survey. Participants also said that they feel the cold and flu season is extending, with 37% being sick earlier and 43% staying sicker longer than previous years. Over half of individuals in the study said they read the medicine labels on products before purchasing, and nearly half said they either mostly avoid or always avoid products that have added sugar. This demonstrates that top concerns for patients when choosing cough and cold products is the ingredients.1

In cold and cough medications, phenylephrine has been a key ingredient and has been mandated by the FDA.2 It has been believed the ingredient is safe and effective for OTC medications; however, according to a recent article in Pharmacy Times, only 38% of the phenylephrine dose is bioavailable after ingestion. This has caused the FDA to revisit the use of phenylephrine in OTC medications, with the agency calling for more substantial evidence supporting the efficacy of the drug when it is taken orally.2

Additionally, in the survey, approximately 71% of individuals said they got sick once or twice during the cold and flu season and 14% reported getting sick 3 times, according to the press release. Approximately 44% bought cold and cough medicine once during the cold and flu season and 42% bought 2 to 4 times.1

Further, approximately 68% are concerned that products contain hidden sugar. Approximately 12% of individuals said they were diagnosed with diabetes and 13% were diagnosed with pre-diabetes, according to the results. Nearly 33% individuals said they had high blood pressure. Approximately 43% of respondent who had diabetes said they had a spike in their blood sugar levels after taking cold and cough medicine, according to the press release. Of those with high blood pressure, approximately 38% said they experienced a spike in blood pressure after taking cold and cough medicine.1

In the Pharmacy Times article, the author states that pharmacists must educate patients on the regulatory changes, alternative formulas, and other evidence-based choices.2 Following the FDA’s announcement, some major community chain pharmacies are removing some of the cough and cold medicines from the OTC shelves, though the FDA has not decided whether or not manufacturers should remove these products containing phenylephrine, according to the article.2

Reference

  1. Confronting "Tripledemic," Americans Are Concerned About Cough Syrup Effectiveness and Formulas with Hidden Sugars. News release. PR Newswire. December 18, 2023. Accessed January 19, 2024. https://www.prnewswire.com/news-releases/confronting-tripledemic-americans-are-concerned-about-cough-syrup-effectiveness-and-formulas-with-hidden-sugars-302017149.html?tc=eml_cleartime
  2. Adapting to the FDA’s Phenylephrine Status Change in OTC Cold and Congestion Medications. Pharmacy Times. January 8, 2024. Accessed January 19, 2024. https://www.pharmacytimes.com/view/adapting-to-the-fda-s-phenylephrine-status-change-in-otc-cold-and-congestion-medications
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