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U.S. Department of Health and Human Services


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December 11: Do you believe that the drugs FDA approves are really safe? I don't totally agree with that.

CDER Director's Mailbag

No drug product is perfectly safe. Every single drug that affects the body will have some side effects. During the review process, FDA considers both the benefits and risks of all medications submitted for approval. In addition, FDA makes sure the package insert outlines the benefits and risks reported in the tested population. You and your health care provider should decide together whether the benefits outweigh the risks for YOU. Talking about your medicines with your health care provider is just as important and good for your health as a complete check-up and taking your medicine as directed.