More than 600 ingredients or dosages that once were available by prescription only are now available over-the-counter (OTC) During the past twenty-five years, the FDA has authorized the over-the-counter sale of more than fifty drugs that previously were sold by prescription. Most of those drugs fall into the categories of decongestants, antihistamines, analgesics (painkillers), anti-ulcer, and anti-itch medications.
Drug companies like to market a prescription drug as OTC because it means more profits for them. But there is also an advantage for consumers: convenience. You don’t need to go to your health-care practitioner and get a prescription for your medications. That’s where you may also save money, depending on the type of insurance coverage you have. Some OTC versions of prescription drugs are less expensive, but in many cases they are not And while some insurance plans pay most or all of a prescription’s cost, you must foot the bill for OTC drugs.
Making the Transition to OTC. Not just any drug can make the transition from prescription to OTC. The FDA has criteria a prescription drug must meet before it can make the transition.

  • The prescription drug must have at least a three-year history of safe use
  • The OTC drug cannot cause serious side effects if it is misused
  • The medical condition the OTC drug will treat must be self-diagnosable. That’s why you can buy OTC drugs for the common cold or a headache but not for high cholesterol or Alzheimer’s disease
  • The OTC drug should relieve symptoms

In 2000, Merck & Co., maker of lovastatin (Mevacor), and Bristol-Myers Squibb, maker of pravastatin (Pravachol), petitioned the FDA to sell these two cholesterol-lowering prescription drugs over-the-counter. However, in 1997, the FDA had clearly stated in its “Guidance for Industry” statement that cholesterol-lowering drugs should be available by prescription only. One reason is that these drugs are used to treat a condition that is not self-recognizable. You must be tested for your cholesterol level, and your levels need to be monitored by a health-care practitioner. Thus cholesterol-lowering drugs do not meet one of the criteria set forth by the FDA, and Merck and Bristol-Myers Squibb were turned down.

The Safety Factor. Just because a drug is OTC does not mean it can’t cause serious side effects if it isn’t taken properly. For example: aspirin, the “wonder drug,” can cause bleeding of the stomach if taken in too high doses and, among a small percentage of people, even when taken at recommended doses. Thus any drug, prescription or OTC, should be taken according to directions or your health-care practitioner’s instructions, and regarded with caution.


  1. sim says:

    I prefer OTC drugstores

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