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Before a prescription drug can be marketed and sold to the American public, it must be approved by the U.S. Food and Drug Administration (the FDA). Companies that seek FDA approval of a prescription drug must first conduct laboratory and animal tests. If these studies indicate that the drug is safe and effective, tests must then be done with human subjects.

Based on the results, the company may apply for FDA approval, providing the FDA with:

  • Documentation of all test results
  • Information to demonstrate to the FDA that the medicine can be manufactured without risk of injury to anyone
  • The proposed label for the drug, which must include instructions on how the drug is to be used, any known risks associated with use of the drug, and the uses for which the drug has been shown to be effective

The application is then subjected to a review by FDA doctors and scientists to determine whether the potential benefits outweigh the known risks. If so, the drug will be approved.
Prescription Drugs
The unfortunate reality is that many pharmaceutical products approved by the FDA demonstrate serious side effects when marketed to the general public. Often, the clinical studies conducted by pharmaceutical companies do not include sufficient numbers of test subjects. In some instances, drug companies intentionally ignore or hide information suggesting or demonstrating potentially serious side effects.

Protecting Your Rights When You Have Suffered Side Effects from the Use of a Prescription Drug

A claim for injuries suffered in connection with the use of a prescription drug typically falls under a legal theory of negligence. You can file suit as an individual claimant, but most prescription drug cases are brought as class actions, where you join with others who have suffered similar injuries after use of the same drug. In a class action, you share the cost of litigation with everyone else in the class, allowing you to pursue a financial award with significantly less expense.

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