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What Does FDA Approval Really Mean For You?

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Approval by the U.S. Food and Drug Administration (FDA) means that clinical studies have proven a drug to be more helpful than harmful for specific diseases and conditions. But FDA approval does not guarantee that a drug is absolutely safe and universally effective. Instead, it signifies that a drug is sufficiently safe and effective when used within the limits defined by its testing for indications, side effects, and contraindications. Even so, the demonstrated risks and benefits may change once a drug is tested in a larger and more diverse group of patients.

 When you fill a prescription for a relatively new drug, you are entering, in effect, a vast and unregulated human experiment. Statistically, a Phase III clinical trial involving several thousand people has its limits. A rare side effect -- for example, one that affects only one in 50,000 individuals -- may not show up during the trials. But once the drug is on the market and prescribed to millions of people, uncommon side effects may start to show up.

Then why not require all drugs to be tested in 50,000 or more people? This would be extremely expensive and would substantially increase the cost of bringing new medications to market. To address the issue, the FDA requires post-marketing studies, in which the drug's manufacturer monitors a sample of people using the drug and reports any new adverse reactions. 

Physicians, pharmacists, and patients themselves can also report drug side effects or problems with the use or quality of medical products by using the FDA's MedWatch system. The MedWatch website gives you the option of printing out a report form to take to your doctor or filling out a form online yourself. To make a report, go to www.fda.gov/medwatch and click on "Reporting Serious Problems to FDA" and then on "Reporting By Consumers." You can also call the FDA at 800-FDA-1088 to request a "MedWatch Voluntary Reporting" form via the mail. 

By reporting side effects or problems with medical products, you can help the FDA to identify risks to yourself and other consumers. In some cases, the FDA decides on the basis of this post-marketing surveillance that a new drug is too dangerous after all and orders it to be withdrawn from the market. 

Posted in Prescription Drugs on December 21, 2010


Medical Disclaimer: This information is not intended to substitute for the advice of a physician. Click here for additional information: Johns Hopkins Health Alerts Disclaimer


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The views expressed here do not constitute medical advice, and do not represent the position of Johns Hopkins Medicine or Remedy Health Media, LLC, which has no responsibility for any comments posted on this site.


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