Safety Considerations
Safety is a major concern when the FDA considers reclassifying a prescription drug as OTC. All drugs have benefits and risks; some degree of risk has to be tolerated if people are to receive a drug's benefits. Defining an acceptable degree of risk is a judgment call.
Safety depends on using a drug properly. For OTC drugs, proper use often relies on consumer self-diagnosis, which leaves room for error. For example, most headaches are not dangerous, but in rare cases, a headache is an early warning of a brain tumor or hemorrhage. Similarly, what seems like severe heartburn may signal an impending heart attack. Ultimately, people must use common sense in determining when a symptom or ailment is minor and when it requires medical attention.
People who purchase OTC drugs should read and follow the instructions carefully. Because different formulations--such as immediate-release and controlled-release (slow-release) formulations--may have the same brand name, the label should be checked each time a product is purchased, and the dosage should be noted. Assuming that the dosage is the same is not safe. Also, different formulations with the same brand name may have different ingredients, so checking the ingredients on the label is important. For example, there are more than a dozen different Tylenol formulations with a vast array of ingredients. Some Maalox products contain aluminum and magnesium hydroxides; others contain calcium carbonate. When selecting a product, people should read the label carefully to determine which product is most appropriate for their particular problem. Labels on OTC drugs, which are required by the FDA, can help people understand what a drug's benefits and risks are as well as how to use the drug correctly.
Often, the labels of OTC drugs do not list the full range of possible side effects. As a result, many people assume that these drugs have few, if any, side effects. For example, the package insert for one analgesic cautions people not to take the drug for more than 10 days for pain. However, the possible serious side effects that can occur with long-term use (such as life-threatening bleeding from the digestive tract) are not mentioned--not on the box, bottle, or package insert. Consequently, people with chronic pain or inflammation may take the drug for a long time without realizing that such use could lead to serious problems.
 See the sidebar Guidelines for Choosing and Using Over-the-Counter Drugs.
See the sidebar Considerations in Reclassifying a Drug as Over-the-Counter.
See the sidebar Reading a Drug Label.
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