In September 2023, a US FDA advisory panel unanimously concluded that phenylephrine, when taken orally, does not effectively relieve nasal congestion.

Final summary minutes of the Nonprescription Drugs Advisory Committee meeting. U.S. Food and Drug Administration. October 2, 2023.

Phenylephrine is an ingredient found in a number of popular OTC cold and allergy medications that many people keep in their medicine cabinets.

 

 

Phenylephrine vs pseudoephedrine

 

This designation allows a drug to be included in OTC products without needing manufacturers to apply to the FDA to use it. If the FDA determines phenylephrine is not effect, manufacturers will be forced to pull products from store shelves, or reformulate them.

FDA clarifies results of recent advisory committee meeting on oral phenylephrine. U.S. Food and Drug Administration. September 14, 2023.

 

That hasn’t happened yet, but it would be a good idea for consumers to start looking for alternatives. The effectiveness of phenylephrine in nasal sprays has not been questioned, so if patients’ preferred oral remedies become unavailable, they can fall back on those.

Phenylephrine grew in popularity after the federal government tightened restrictions around the sale of products containing pseudoephedrine—which can be used to make illicit methamphetamine—in 2006. Cold and allergy medicines containing pseudoephedrine are still available, but consumers have to ask their local pharmacist for it and abide by certain other rules.

Legal requirements for the sale and purchase of drug products containing pseudoephedrine, ephedrine, and phenylpropanolamine. U.S. Food and Drug Administration. November 24, 2017.

 

 

Other questionable OTC remedies

 

Back in 2020, for example, all OTC and prescription products containing ranitidine (which was sold under the brand name Zantac) were pulled due to potential contamination with a probable human carcinogen called N-Nitrosodimethylamine (NDMA).

FDA requests removal of all ranitidine products (Zantac) from the market. U.S. Food and Drug Administration. April 1, 2020.

Patients with conditions like heartburn and gastroesophageal reflux disease could substitute other similar agents (eg, H2 blockers and proton pump inhibitors) that don’t carry the same risk.

 

Consumers need to be careful when using OTC therapies because even popular drugs like aspirin and acetaminophen may be associated with harmful side effects.

 

• Vitamin C: According to the Mayo Clinic, taking vitamin C supplements won’t stop the average person from coming down with a cold, although it may shorten the length of symptoms.

  Cold remedies: What works, what doesn’t, what can’t hurt. Mayo Clinic. June 3, 2022.

   

• Echinacea and zinc: The Mayo Clinic points out there is mixed evidence for these two supplements, with some studies suggesting benefit and others showing no benefit regarding their effect on colds; in addition, zinc comes with potential side effects.

• OTC products for acute cough associated with the common cold: The American College of Chest Physicians (ACCP) recommends against the use of OTC cough and cold medicines or nonsteroidal anti-inflammatory agents until they can be shown to lessen the severity or shorten the duration of cough.

  Malesker MA, Callahan-Lyon P, Ireland B, et al. Pharmacologic and nonpharmacologic treatment for acute cough associated with the common cold: CHEST Expert Panel report. Chest. 2017;152(5):1021–1037.

   

• Aspirin to prevent cardiovascular disease: Based on recent clinical trials, the US Preventive Services Task Force said that people older than 60 should not start taking low-dose aspirin for the primary prevention of CVD; for those age 40-59, the decision should be individualized.

  Aspirin use to prevent cardiovascular disease: Preventive medication. U.S. Preventive Services Task Force. April 26, 2022.

   

• Dietary supplements to manage dyslipidemia: A study published in the Journal of the American College of Cardiology showed that products like fish oil, cinnamon, garlic plus allicin, turmeric curcumin with bioperine, plant sterols, and red yeast rice had no significant impact on LDL, total cholesterol, or triglycerides when compared with a low dose of a proven statin (rosuvastatin).

  Laffin LJ, Bruemmer D, Garcia M, et al. Comparative effects of low-dose rosuvastatin, placebo, and dietary supplements on lipids and inflammatory biomarkers. J Am Coll Cardiol. 2023;81(1):1–12.

   

 

Counseling patients on the use of OTC therapies

 

 

A commentary in the AMA Journal of Ethics provides some tips for how you can respond when one of your patients expresses an interest in pursuing dietary supplements to help manage their chronic disease.

Clinard V, Smith JD. How should clinicians respond to patient interest in dietary supplements to treat serious chronic illness? AMA J Ethics. 2022;24(5):E361–E367.

Gathering a complete list of the OTC products, prescription drugs, and supplements and evaluating them in the context of your patient’s condition, along with potential adverse reactions, is pivotal for overall health.

 

“Overall, when a patient is using or has intentions to use a dietary supplement in place of a prescribed agent, practitioners should approach this decision from the standpoint of the safety and efficacy of the agent,” the authors advise. 

On the other hand, “if the agent’s safety or efficacy is unknown, practitioners should discuss these concerns with the patient and consider if there might be an appropriate dietary supplement alternative for the intended purpose,” the authors added.