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approved. The risk of taking the drug has to be worth the benefit the drug provides. And that's the case for most drugs on the market.
Before approving a drug, the FDA tries to find out about the drug's potential risks. Many side effects show up in the manufacturer's preapproval studies and are noted in the application made to the FDA. But what if a particular reaction happens in only one out of twenty-five thousand people? Or in one out of fifty thousand? Most clinical trials test drugs on only a few hundred to several thousand people. A serious reaction that occurs once in twenty-five thousand times or once in fifty thousand may be missed in these studies. That side effect might remain unknown until tens or hundreds of thousands of people—a number far greater than the average number of people involved in clinical trials—have used the drug.
Though they endeavor to do so, the FDA and drug manufacturers can't anticipate every possible side effect of a drug in every person. Even the safest drugs, when used appropriately, can cause adverse reactions.
An adverse reaction is an unintended, unwanted side effect. It can be unpleasant or harmful, or it may just be unexpected. You can have adverse reactions to many different things: for instance, drugs, medical devices, vaccines, cosmetics, herbs, vitamins, and food. These reactions can range from the mildly irritating to life threatening. Common mild adverse reactions to drugs include stomach upset, drowsiness, dizziness, restlessness, difficulty sleeping, headache, rash, abdominal pain, and diarrhea.
New drugs and old drugs alike can cause adverse reactions. Over-the-counter antihistamines (like Benedryl),
for example, do a great job combating allergies but can cause extreme drowsiness (not a big deal unless you are driving a car or operating dangerous machinery—and then drowsiness can cause serious accidents). Some antibiotics, like penicillin, that have been around for decades, battle bacterial infections well, but can cause mild-to-life-threatening allergic reactions. Other antibiotics, like tetracycline, help people who can't take penicillin, but these drugs often cause stomach or intestinal discomfort. Even common household aspirin can irritate your stomach lining. Worse yet, aspirin has been known to trigger Reye's syndrome when given to children battling chicken pox, influenza, or other viral infections. These side effects may occur even when users are exactly following the manufacturer's instructions for use (which is not the case when OTC drugs are abused).
All these side effects are considered adverse reactions, whether mild or severe, and most were observed in clinical trials before the FDA approved each drug. The FDA weighed the drug's effectiveness and its potential to do good against its potential to do harm. The potential for abuse is one of the factors weighed by the FDA before each medication is approved for public use. Approval doesn't mean that the drugs are harmless—they still might cause adverse reactions, and they can still be abused. To make sure that prescribing physicians and the public know about potential adverse reactions, the FDA requires manufacturers to tell them of both the benefits and the risks of any new drug they want to sell.
Weight-loss aids and other potentially harmful dietary supplements are not considered drugs under FDA guidelines. Instead, they are categorized as food, which means that they are not subject to the same types of regulations as drugs. Unlike drugs, they are not allowed to claim that they cure, treat, or prevent a disease or illness, but they can inform consumers how ingredients contained in them can affect organs or processes, or that there are relationships between its ingredients and lowering the risk of a disease. However, the FDA does not regulate whether or not a dietary supplement is safe and effective, or the quality of the ingredients used. The only time a manufacturer must notify the FDA that they intend to produce a supplement is when its product contains a new dietary ingredient.
Who Uses Over-the-Counter Drugs?
Most drugs that are subject to abuse have a typical user profile. In the case of OTC drugs, teenagers in high school and even middle school are the group that is most likely to engage in abuse. Studies have shown that the largest increases in abuse are committed by people between the ages of thirteen and sixteen. OTC drugs are especially popular in dance clubs and raves, where they are used as an alternative to the more traditional drug of choice, ecstasy. This increase in abuse is being reflected by national data. The American Association of Poison Control Centers reported that between 2000 and 2003, poison center calls related to teenage DXM abuse rose from 1,623 to 3,271. In that same time period, calls from other age groups rose only from 900 to 1,111.
Continue reading here: Choosing OTC Drugs Over Others
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