FDA Considering Making Many Drugs OTC

FDA Considering Making Many Drugs OTC

Story at-a-glance -

  • The FDA is holding a two-day meeting to discuss whether medications for numerous chronic diseases should be made available over-the-counter (OTC), without a prescription
  • The majority of Americans are already taking too many drugs, and easier access makes it likely that people will take even more -- even though there are many risks to self-medicating, and many chronic conditions are best treated without drugs.
  • Anyone engaging in “polypharmacy” (taking more than one drug) increases their risk of experiencing harmful side effects exponentially, and this is true of both prescription and OTC drugs
  • Easier access to drugs is not the answer to solving the nation’s failing health; your body can heal itself if you give it the proper "tools” -- and this is true even if you have certain chronic diseases

By Dr. Mercola

If you're an "average" 65-year-old (or older) adult living in the United States, you fill more than 31 prescriptions per year.

Those aged 19 to 64 take more than 11 prescription drugs per year, while even children take an average of 4, according to statistics from the Kaiser Health Foundation.1

It is also important to realize that this does not take into account over-the-counter (OTC) drugs, which would easily push these numbers significantly higher.

In 2010 alone, U.S. retail sales of OTC drugs reached $17 billion (and that excluded sales from Wal-Mart),2 and that is set to go through the roof if the U.S. Food and Drug Administration's (FDA) plans to reclassify several prescription drugs to OTC status come to fruition.

OTC Medications for Chronic Disease May be Coming Your Way …

The FDA is holding a two-day meeting to discuss whether medications for numerous chronic diseases should be made available without a prescription. This includes drugs for:

  • High blood pressure
  • Cholesterol
  • Migraines
  • Asthma

The idea is that people would be able to access the drugs more quickly and without having to make a visit to their doctor's offices, which would save patients (and insurance companies) time and money by reducing overall health care costs.

Since 1976, 106 ingredients or medications have been switched from prescription to OTC status, and this is a trend many Americans appear to support. A survey sponsored by the Consumer Healthcare Products Association (CHPA) revealed that 80 percent of U.S. consumers had used an OTC medicine in the last year, and 86 percent believe OTC drugs help them lower health care costs.

Further, 89 percent said OTC medications are an "important part of their overall family health care," while 81 percent use them as a "first response" to minor ailments.3 Why are these statistics, and the FDA's plan to make even more drugs available over the counter, concerning?

Because the majority of Americans are already taking too many drugs, and easier access makes it likely that people will take even more -- even though many chronic conditions, like elevated cholesterol, are best treated without drugs, and there are many serious health risks to self-medicating. As pointed out in Current Drug Safety:4

"Potential risks of self-medication practices include: incorrect self-diagnosis, delays in seeking medical advice when needed, infrequent but severe adverse reactions, dangerous drug interactions, incorrect manner of administration, incorrect dosage, incorrect choice of therapy, masking of a severe disease and risk of dependence and abuse … some of the most important dangers related to self-medication practices, particularly [include]: polypharmacy and drug interactions, medications abuse or dependence, misdiagnosis and incorrect choice of treatment."

The Dangers of Polypharmacy

Anyone taking more than one drug increases their risk of experiencing harmful side effects. The word 'polypharmacy' simply means "many drugs," but refers to instances where an individual is taking too many drugs -- either because more drugs are prescribed (or taken over-the-counter) than clinically indicated, or when the sheer number of pills simply becomes a burden for the patient.

According to the CHPA survey, the majority of Americans (92%) believe that OTC medicines are safe and effective. But deaths due to unintentional drug overdoses have increased roughly five-fold since 19905-- and the risk of all adverse reactions, including serious and even life-threatening complications, goes up dramatically the more drugs you take.

This applies directly to many of you reading this, as nearly 40 percent of Americans take four or more prescription drugs, along with an untold number of OTC medications. While the drug label will contain some safety information, it cannot possibly warn you about the risks of every medication combination. For one thing, oftentimes the risks are not yet known; there are more than 100,000 OTC medications on the U.S. market alone, making the combinations virtually endless, and a detailed risk assessment equally unreachable.

But make no mistake about it, when you combine medications you are essentially acting as the guinea pig in your own science experiment. Many are lulled into a false sense of security when it comes to OTC drugs, but the side effects and risks are just as severe as those for prescription medications.

For instance, acetaminophen (Tylenol type products) is the leading cause of acute liver failure in the United States.

This happens so often because people take multiple OTC Tylenol-containing products without realizing it, which leads to unintentional, and sometimes fatal, overdose. Another example is antihistamines, which are commonly taken for cold symptoms. If you combine these with sedatives, tranquilizers, or drugs for depression, it may increase the depressant effects (such as sleepiness), impacting your concentration level and ability to drive a car. Or, taking antihistamines with a prescription drug for high blood pressure (which may soon become over-the-counter) may cause your blood pressure to increase and may also speed up your heart rate.

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Common Signs of OTC and Prescription Drug Reactions

Common signs and symptoms that may be indicative of a detrimental interaction between two or more drugs include:

Tiredness, sleepiness or decreased alertness

Confusion (chronic or intermittent)


Anxiety or excitability

Constipation, diarrhea or incontinence

Dizziness and/or falls


Skin rashes

Loss of appetite

Depression or lack of interest in your usual activities

Hallucinations -- seeing or hearing things

Decreased or altered sexual behavior

Keep in mind that symptoms of drug side effects can occur very quickly after starting a new medication, or it may take a while. Many factors can come into play, so do not dismiss new symptoms as unrelated to a drug reaction just because you've been on the drug, or drugs, for a few weeks or even months. The bottom line is, if you're on a prescription drug, and answer yes to ANY of the questions below, you may be at increased risk of polypharmacy:6

  • Do you take herbs, vitamins or OTC products?
  • Do you have to take medicine more than once a day?
  • Do you suffer from arthritis?
  • Do you use different pharmacies to fill your prescriptions?
  • Do you have poor eyesight or hearing?
  • Do you live alone?
  • Do you sometimes forget to take your medication?

Ironically, another significant problem of polypharmacy is that it leads to ... more prescriptions! Yes, the side effects of polypharmacy are oftentimes confused with symptoms of yet another disease or health problem, setting into motion a vicious cycle of decreasing health followed by more drugs rather than fewer.

Many Chronic "Diseases" Can be Managed and Even Reversed with Lifestyle Changes

The idea that "easier access to drugs" is the answer to the nation's failing health is, from my point of view, clearly misguided. There is a dangerous misconception in the United States, among both patients and physicians, that when you're sick you need a drug to feel better. This is precisely why 81 percent of Americans reach for an OTC drug as a "first response" to minor ailments.

Clearly there are some cases when properly prescribed medications can and do save lives or relieve pain. But in the vast majority of cases, drugs are overused and overprescribed, even in cases where the risks far exceed any potential benefits.

This is not only my opinion -- it's fact! A study from the prestigious New England Journal of Medicine found absolutely no correlation between spending more on drugs and improved patient outcomes, which is really no surprise. So one of the most important questions to ask yourself and your health care practitioner before deciding to take any drug is:

Do I really need it?

Oftentimes you'll find the answer is no. So I hope that you will view drugs as a last resort instead of a first choice, and will instead embrace the massive shift in thinking to realize that your body can often heal itself if you give it the proper "tools." Maintaining good health as you age, without the use of drugs, IS possible, and this is true even if you have certain "chronic diseases." Examples of health problems that typically don't require drug intervention include:


Heart disease

High blood pressure

High cholesterol



If you start with just the five steps listed below, you will be embarking on a journey to outstanding health and drug-free wellness. You may even be able to reverse some of your chronic conditions, like diabetes or high blood pressure:

  1. Eliminate sugar, especially fructose and most grains from your diet.
  2. Eat unprocessed, high-quality foods, organic if possible. If you haven't reviewed my comprehensive free nutrition program, please do so when you have a moment.
  3. Get sufficient amounts of sun exposure on large areas of your skin to optimize your vitamin D levels.
  4. Consume enough high-quality animal-based omega-3 fats, such as krill oil.
  5. Exercise regularly, including high-intensity burst exercises like Peak Fitness.