Your patients may not be aware that common OTC medications and supplements often don’t live up to their claims, with only questionable effectiveness for various health conditions.
In late 2023, an FDA advisory panel determined that orally administered phenylephrine is not an effective nasal decongestant, despite being exclusively marketed to consumers for this purpose.
When patients express an interest in adding a nonprescription remedy to their treatment regimen, it’s important for physicians to compile a list of the OTC and prescription medications their patients are taking, as well as any dietary supplements, to prevent any negative drug interactions.
In September 2023, a US FDA advisory panel unanimously concluded that phenylephrine, when taken orally, does not effectively relieve nasal congestion. 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
Although the effectiveness of oral medications containing phenylephrine has been questioned for years, the panel’s deliberations raise the real possibility the FDA could decide in the coming months that the drug will no longer be “generally recognized as safe and effective.”
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.
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.
Other questionable OTC remedies
If oral phenylephrine products are ultimately removed from the market, they wouldn’t be the first OTC remedies to suffer that fate.
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). 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.
And others, particularly various dietary supplements, have uncertain health benefits despite widespread use. Here are some of the most popular examples.
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.
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.
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.
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).
Counseling patients on the use of OTC therapies
OTC remedies are likely to remain popular with your patients, so you should advise them to stick with options that have been proven to be safe and effective in randomized controlled trials.
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. 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.
What this means for you
The FDA officially determined that oral phenylephrine, which is ubiquitous in OTC cold and allergy medications, is not an effective nasal decongestant. This highlights the fact that some remedies available without a prescription could have questionable benefits and/or harmful side effects. You should check with your patients to find out what OTC and prescription therapies they’re taking or thinking about adding to their treatment regimens in order to best manage any potential issues that might arise.