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The FDA Today, Part 2 |
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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 peoplea number far greater than the average number of people involved in clinical trialshave 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 |
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