OTC Drug Safety: Are We Playing Doctor At Our Peril?

Most Americans assume that if the Food and Drug Administration (FDA) approves a medication for over-the-counter (OTC) sale, it must be safe. Every pharmacy and convenience store offers a wide variety of pain relievers, allergy medicines, cold and cough remedies and indigestion aids. We spend billions on such products. The FDA Commissioner, Dr. Marty Makary, is pushing to make many more drugs available without a prescription. Before we celebrate easier access, though, it’s worth asking a harder question: is OTC drug safety the missing piece that could make such an expansion truly safe?

A Brief History of the OTC Pharmacy Counter

Americans have a love-hate relationship with over-the-counter medications. A long time ago, virtually all drugs were sold without a prescription. General stores sold old-time favorites for headaches, hangovers, back pain and constipation.

Traveling medicine shows sold a variety of patient medicines off the back of the wagon. The term “snake oil” was used to describe a cure-all of dubious origins and effectiveness. Opioids (laudanum, paregoric and morphine) were available without medical supervision.

After some tragedies, Congress began to impose some order. The Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938 gave the FDA authority to ensure drugs were safe. A 1951 amendment split medicines into two categories: prescription drugs requiring professional supervision, and everything else sold over the counter.

An additional 1962 law required all drugs, including OTC products, to be both safe and effective. In those days, fewer than half of the products sold without prescriptions met that standard.

Since then, many popular prescription drugs have made the jump across the pharmacy counter. Ibuprofen (Advil, Motrin IB), naproxen (Aleve), the antihistamine diphenhydramine (Benadryl) and even acetaminophen (Tylenol) were once available only by prescription. More recently, heartburn drugs like omeprazole (Prilosec OTC) and esomeprazole (Nexium 24HR) followed, as did steroid nasal sprays like fluticasone (Flonase) and triamcinolone (Nasacort).

OTC Drug Safety and the FDA

When a medication such a omeprazole or fluticasone is sold by prescription, the physician and pharmacist have access to the official prescribing information. This is detailed and lengthy and provides a great deal of data about proper usage, adverse reactions warning and precautions. Nonprescription products contain only a fraction of this OTC drug safety material.

The FDA seems to have concluded that when it allows a prescription drug to be sold over the counter, it magically loses many of its potential side effects. Although there are some warnings on the label, they are dramatically different from the information available to healthcare professionals. There also seems to be an assumption that everyone who uses an OTC product will carefully read and understand the instructions and cautions that are listed. We’re not so sure that is an accurate assumption.

The FDA’s New Push: Everything Is OTC Unless It Isn’t

Commissioner Makary wants to make many more drugs available without prescription. He is on the record saying that:

“…everything should be over the counter, not requiring a prescription, unless it’s unsafe, unless you need laboratory tests to monitor how it’s being received by your body, or if it can used for some nefarious purpose, or it’s addictive.”

Dr. Makary wants to reduce red tape and make it easier for drug companies to take their popular products OTC. One of his pet projects is over-the-counter access to vaginal estrogen. He’s been quoted:

“There has been tremendous demand for hormone replacement therapy for postmenopausal women; we’ve been tracking it closely.”

The FDA, under Dr. Makary’s oversight, has removed the boxed warning associated with HRT products like Premarin and PremPro. The cautions about cardiovascular disorders such as blood clots in the legs or lungs, strokes and heart attacks have been scaled back. The FDA has also removed warnings about breast cancer and “Probable Dementia.” Dr. Makary has expressed interest in seeing vaginal estrogen made more readily available, possibly even without a prescription.

An OTC Drug Safety Problem: Many People Don’t Read Labels

The FDA makes a foundational assumption when approving drugs for OTC sale: that consumers will read the label and follow the directions. The evidence suggests this is largely wishful thinking.

Research published in the journal Pharmacy (Oct. 26, 2018) found that fewer than half of consumers read the entire package label before taking an OTC medicine. Eye-tracking studies reveal that shoppers spend less time reading warnings than they do looking at the brand name. A separate study found that only 26% of those surveyed even checked the active ingredients on the label (American Journal of Medical Sciences, November 2016).

This matters enormously because brand names tell you almost nothing. Do you know what’s in Tylenol Cold + Flu Severe Warming Honey Lemon Liquid? The active ingredients are: phenylephrine, guaifenesin, dextromethorphan and acetaminophen. Each carries its own dosing rules, interactions and side effect profiles. Most consumers have no idea.

A Case Study in OTC Drug Safety Failure: Phenylephrine

The most striking recent example of OTC drug safety breakdown involves phenylephrine (PE), the decongestant found in many popular cold and allergy products. The FDA admitted in September 2023 that oral phenylephrine “is not more effective than placebo.” We first wrote about this in the original edition of The People’s Pharmacy. That was over fifty years ago.

Yet for decades, more than 240 million bottles of cough, cold and allergy products containing phenylephrine were sold in the US annually. Americans spent more than $1.8 billion on these products every year. OTC drug safety pharmacist oversight might have caught this problem far sooner, since pharmacists in direct contact with patients could have flagged the lack of effectiveness.

OTC Drug Safety and Dosing Confusion

Even when the drugs work, the dosing instructions for common OTC pain relievers are maddeningly inconsistent, and that inconsistency could get people hurt.

Take the difference between Advil (ibuprofen) and Aleve (naproxen). Both are NSAIDs (nonsteroidal anti-inflammatory drugs). Many people treat them interchangeably. But the maximum dose of Advil is six tablets per day, while the maximum for Aleve is only three. Someone who takes Aleve the same way they take Advil is doubling the daily limit of naproxen. That could increase the risk for gastrointestinal bleeding, kidney damage or cardiovascular complications.

Research confirms this is happening. Studies published in Pharmacoepidemiology and Drug Safety (Dec. 2012) found that many people exceed the daily limit of OTC ibuprofen, and that over a third of ibuprofen users were simultaneously taking another NSAID, often without realizing it. A person might take Motrin IB for back pain during the day and Aleve PM to sleep at night, not realizing that both are NSAIDs.

What’s on the Doctor’s Label vs. What’s on Yours

The information gap between what physicians see and what patients see is striking, and it goes to the heart of OTC drug safety problem.

When a physician prescribed ibuprofen, she may have seen a prominent black-box warning stating that NSAIDs cause increased risk of:

“…serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal,” and increased risk of “…serious gastrointestinal adverse events including bleeding, ulceration, and perforation.”

Doctors are warned about kidney damage, fluid retention and hypertension risks. They are told not to prescribe NSAIDs late in pregnancy.

The OTC Advil label does note heart attack and stroke risk, and does warn about stomach bleeding. But the black-box prominence is absent, and the full detail of long-term kidney, liver and cardiovascular risk is not included. We have received heartbreaking letters over the years from readers who suffered serious side effects while taking OTC NSAIDs they assumed were safe.

A similar information gap exists for heartburn drugs. OTC labels for Nexium 24HR and Prilosec OTC do not warn users about the potential link to kidney disease, a serious complication that led AstraZeneca to settle more than 10,000 claims for $425 million. And many consumers have no idea that taking PPIs for more than two months can cause rebound acid hypersecretion that makes it very hard to stop. Long-term PPI use has been associated with C. diff infections, pneumonia, cardiovascular complications and weakened bones, none of which appear on the OTC label.

The Solution: A Third Category, Not Two

Here at The People’s Pharmacy, we have long argued that the binary choice between prescription and OTC is a false one. Many countries have a third category: behind-the-counter (BTC) drugs, dispensed by pharmacists without a doctor’s prescription, but not placed on open shelves either.

This model already exists in limited form in the US. Pseudoephedrine (Sudafed) moved behind the counter in 2005 to prevent its use in illicit methamphetamine production. Plan B emergency contraceptive requires a pharmacist interaction. In 49 states, insulin, a drug whose dosing errors can be fatal, can be purchased without a prescription but with a pharmacist’s involvement.

Other countries have established a BTC category that is far broader. We think that represents the best current model for OTC drug safety with pharmacist oversight. In Australia, pharmacists can dispense the antiviral famciclovir for herpes outbreaks and epinephrine for severe allergic reactions.

New Zealand pharmacist prescribers can provide oral contraceptives, cholesterol-lowering drugs and blood pressure medicines. In England, pharmacists can prescribe antibiotics for skin infections, steroid nasal sprays for sinusitis, and statins after an on-the-spot cholesterol test. Canadian pharmacists assess shingles rashes, prescribe treatment for urinary tract infections and eczema, and handle tick bites and pink eye.

None of this requires a trip to a physician’s office that may be weeks away, or a telehealth visit with a provider who has never met you.

Why Pharmacists Are the Right Answer for OTC Drug Safety

There are over 60,000 pharmacies across the United States, and most Americans live within five miles of one. Pharmacists are among the most accessible and extensively trained healthcare professionals in the country. They are ideally positioned to conduct brief but meaningful conversations about a patient’s other medications, underlying conditions and risk factors, precisely the conversation that doesn’t happen when someone picks up a bottle of Advil in a gas station.

The FDA has historically been reluctant to create a BTC category. But as Dr. Makary moves to expand OTC access, a goal that has merit, he should simultaneously champion the pharmacist oversight that makes OTC drug expansion safe rather than reckless. The answer to “more OTC drugs” should be “more OTC drugs with pharmacist consultation,” not a race to put powerful medicines in convenience store aisles without any professional check.

We would also gently suggest that the agency reconsider some drugs currently sold OTC without restriction. NSAIDs like ibuprofen and naproxen are sold in warehouse-sized bottles in big-box stores. Visitors from countries where NSAIDs are dispensed in limited quantities, often 16 pills per pack, behind a pharmacy counter are frequently astonished. If pharmacists were dispensing these medications and counseling patients on proper dosing, drug interactions and warning signs, the rates of overdose and complication would almost certainly fall.

What You Can Do Right Now to To Improve OTC Drug Safety

OTC drug safety pharmacist oversight is a policy goal, but there are practical steps you can take today:

1. The most important one is to actually read the label, all of it, not just the dosage.
2. Check the active ingredients so you know what you’re actually taking.
3. Check for interactions with any other OTC or prescription drugs you use.
4. Follow the duration limits: pain relievers are generally not to be taken for more than 10 days, and PPIs for no more than 14 consecutive days.
5. Take the smallest effective dose, especially for NSAIDs.

The Bottom Line

We are strong advocates for informed self-care. Patients should have access to effective treatments and the knowledge to use them wisely. But the current trajectory, more OTC drugs with minimal guidance, risks widening the OTC drug safety gap even further.

Convenience should not come at the cost of safety! Before the FDA moves more drugs onto store shelves, it should consider a critical question: Are we giving people access, or asking them to play doctor without the training?

A third category, behind the counter, may be the safest path forward.

OTC Drug Safety Requires Pharmacist Involvement!

Ask your pharmacist! Pharmacists are highly trained health professionals. The more guidance they can offer while people make decisions about medications, the safer people will be.

Do not ask the pharmacy technician. Those folks are not that well trained. They can find your prescription medicine and ring up your transaction. They cannot provide health information.

Pharmacists are clinicians who can tell you whether your OTC heartburn pill is safe alongside your blood pressure medication, whether your naproxen dose is within range, or whether an antiviral option might be available to you. The more you involve them, the safer you will be, which is exactly the argument for making that involvement a formal, system-wide expectation rather than an afterthought.

If you found this article of value, please share it with friends and family. Thank you for your support. If you have thoughts about access of OTC drugs, please put them in the comment section below. Have you ever experience a problem with an OTC medication? What are your favorites? We would love to hear from you.