Drug Recalls & Market Withdrawals
A look inside prescription drugs and why they get removed from the market
All medications released for public use must be approved by the United States Food and Drug Administration. In most cases, the drug goes through a rigorous testing process to insure that it is safe for the public. However, there have been cases where a drug has been released only to find that it can cause serious side effects that were not discovered during the testing process. When this happens, the manufacturer or the FDA may issue a drug recall or pull the drug from the market completely.
How Does the FDA Know of a Drug Problem?
The FDA continues to monitor the drug once it is placed on the market. When new side effects are discovered, the organization may simply update the label to warn of the new side effect or they may request that the manufacturer remove the drug from the market if the side effect is dangerous. In addition to FDA monitoring, doctors and consumers may report any adverse reactions to the FDA through an online reporting system.
Pulling the Drug from the Market
If a side effect or interaction is deemed to be dangerous to patients, it may be pulled from the market. Manufacturers often make the decision to voluntarily recall a drug that appears to be unsafe, or the FDA can order them to remove the product. In some cases, the drug may cause additional health problems such as heart attack, stroke or uncontrollable internal bleeding. A dangerous interaction with a common drug or food may also trigger a drug recall. There have also been instances when a manufacturing or packaging error led to a drug recall.
How a Recall Works
Normally, a manufacturer will issue a voluntary recall after receiving a significant number of complaints from patients, after clinical trials or a problem at a manufacturing plant. The FDA maintains a database of product recalls so patients can check to see if a drug they are taking has been recalled. If the manufacturer does not remove the drug voluntarily, the FDA can order them to do so. Patients can return drugs in a recall and receive a refund. A recall is different than a market withdrawal. In most cases, a market withdrawal occurs when a drug is pulled from the market, normally due to declining sales or increasing litigation based on dangerous side effects.
If you or a loved one have been injured by a drug that has been recalled, contact the personal injury attorneys at Lundy Law to learn what rights you may have. You may set up an initial consultation by calling 1-800-Lundy Law or completing the simple form on our website.