How does FDA decide when a drug is not safe enough to stay on the market?

A drug is removed from the market when its risks outweigh its benefits. A drug is usually taken off the market because of safety issues with the drug that cannot be corrected, such as when it is discovered that the drug can cause serious side effects that were not known at the time of approval. However, completely removing a unique product from the market could be very dangerous to people who depend on the drug. So, decisions to remove products from the market are made very carefully, especially if people would be in danger without the product.

New safety concerns identified after a drug is approved for marketing sometimes can be addressed by adding information, including warnings, to the label of the product. In more severe cases, even warnings and other measures to minimize the risks of using the drug may not be enough to protect patient safety. In such cases, when a medication's risks and known dangers outweigh its benefits, FDA and/or the manufacturer may decide that the product should be withdrawn from the market.

If FDA makes the decision, FDA notifies the manufacturer that the drug should no longer be marketed. Usually, the manufacturer voluntarily stops marketing the product at FDA’s request. If the manufacturer disagrees with FDA’s decision, then FDA can take legal action to remove the unsafe drug from the marketplace and withdraw approval.