Pharmaceutical drugs sold in the United States must be safe for patients. When it's determined that a drug poses a health risk to patients, the medication can be recalled. Patients may be asked to return their prescription to a doctor or pharmacy, and manufacturers can try to fix the problem. This article provides a general overview of why and how drugs are pulled from the market.

Before the Recall: Regulating Pharmaceutical Drugs

Drug safety is a continuous effort. Once the FDA approves a drug, the agency continues to monitor the drug when it reaches the market. The FDA updates drug labels to keep patients informed about side effects, health risks, and interactions. Manufacturers receive and review reported problems, and the FDA maintains its own online reporting system. Doctors make their own decisions on when and how to recommend a drug to patients. Researchers study a drug's effectiveness and side effects while comparing it to similar drugs. These efforts can address most problems with pharmaceutical drugs without resorting to a recall.

Reasons for Pulling a Drug From the Market

When a drug is discovered to pose a health risk to patients after reaching the market, a recall may ensue. Manufacturers and the FDA make recall decisions on a case-by-case basis for individual drugs. However, there are some common reasons for issuing a recall:

• Risk of Health Problems - Sometimes further study reveals a connection between taking a drug and a potential health problem. Some pharmaceutical drugs have been linked to an increased risk of heart attack, stroke, kidney failure, and other serious complications.
• Previously Unknown Drug Interactions - Mixing drugs can cause health problems. Sometimes a drug may be discovered to cause problems when taken with another drug, a certain type of vitamin, or certain foods.
• Manufacturing and Packaging Errors - Sometimes a problem at the factory will require a recall. A contamination problem may make a drug unsafe for consumption, or a packaging error may unseal a drug before it reaches the patient.

How a Recall Works

Most commonly, a manufacturer will initiate a voluntary recall for an unsafe drug. This may occur after the manufacturer receives a high number of reported problems from patients, after research studies or clinical trials determines that a drug increases the risk of serious complications, or after a problem at a manufacturing plant puts patients at risk. While these recalls are technically voluntary, in many cases they occur at the FDA's request.

The FDA works closely with manufacturers during a recall. The agency maintains a database of product recalls for the public, and assists manufacturers in retrieving their drugs from the market. The agency also uses a recall classification system to highlight the seriousness of the problem. Finally, the FDA is empowered to issue a mandatory recall order for a pharmaceutical drug. While this power is infrequently used, the threat of it generally encourages manufacturers to take the necessary steps to remove a drug from the market.

Market Withdrawal vs. Recall

Manufacturers may also decide to simply withdraw a drug from the market. These "market withdrawals" (sometimes called "product withdrawals") are not recalls - existing drugs on the market do not have to be returned. Instead, the manufacturer simply stops distributing a drug. This gradually removes a drug from the market by cutting off its supply.

Market withdrawals tend to be business decisions. A manufacturer may conclude that falling sales revenue makes selling a drug unprofitable, or that a rise in product liability lawsuits has damaged the brand and is hurting the company's public image. Ceasing to sell a drug can remove it from the market without attracting the attention of an actual recall.