With the recent recall of Vioxx, a prescription anti-inflamitory, the general public has to wonder…”How safe our are medications”? And whose responsibility does it fall under to make sure that those medications are safe and have no long term effects on the body? Does that responsibility fall to the doctors? The pharmaceuticals? The FDA? Or does is ultimately fall to the patient themselves?
Does the FDA test drugs?
FDA does not develop, manufacture or test drugs. Drug manufacturers submit full reports of a drug’s studies so that the Center can evaluate its data. The studies answer the question: “Does this drug work for the proposed use?” By analyzing the data, CDER reviewers assess the benefit-to-risk relationship and determine if the drug will be approved.
Once FDA approves a drug, does this mean that the product is perfectly safe?
No drug product is “perfectly” safe. Every single drug that affects the body will have some side effects. Since the FDA considers both the benefits and risks of all medications before approval, side effects are generally not serious. For every drug FDA approves, the benefits are balanced against its risks. In addition, FDA makes sure the labeling (package insert) outlines the benefits and risks reported in the tested population. You and your health-care provider should decide together if 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.
What should I do if I’ve had a serious side effect to an over-the-counter or prescription medicine?
Contact your health-care provider right away so that they can advise you on the necessary actions to take. Also, urge the provider to report the problem to FDA’s MedWatch hotline, at 800-FDA-1088. Your health care provider, however, is not required to report to FDA. Therefore, consumers can report problems directly. For more information, visit MedWatch.
