Why Drugs Get Pulled From the Market

Every year, dozens of prescription drugs are either recalled or withdrawn from the market. Some companies recall a medication because the Food and Drug Administration (FDA) determines it's dangerous. Drug manufacturers often choose to issue a recall for their own reasons.

Pharmaceutical drugs sold in the United States must be safe for patients. The FDA may order a recall after determining a drug poses a health risk. Manufacturers may also ask patients to return their prescriptions to their doctor or pharmacy so manufacturers can try to fix the problem. Other times, the drugmaker permanently pulls a drug from the market.

This article provides a general overview of why drug recalls occur and why pharmaceutical companies pull them from the market. It will also explain briefly how the recall and withdrawal process works.

Before the Recall: Regulating Pharmaceutical Drugs

Drug safety is a continuous effort of those in the healthcare field. Once the FDA approves a drug, it continues to monitor the medication. The FDA updates drug labels to inform patients about drugs' adverse side effects, health risks, and interactions.

When a manufacturer receives news of a reported problem, it investigates whether it can resolve it. The FDA also maintains an online reporting system to help educate patients and physicians about the dangers of specific medications and medical devices.

Doctors must familiarize themselves with the warnings and potential dangers of various drugs. This way, they can decide which drugs to prescribe to their patients. At the same time, medical researchers conduct ongoing studies to evaluate the negative impacts of specific medications. They publish their findings so that healthcare providers and patients can decide the best course of treatment.

Ideally, one or all of these efforts can address potential problems with pharmaceutical drugs without requiring a recall.

Reasons for Pulling a Drug From the Market

It can be challenging for laypeople to understand when and why drugmakers recall or pull a particular drug from the market. Typically, when a drug manufacturer or the FDA learns that a drug poses a health risk to patients, they issue a recall.

Drugmakers and the FDA usually make recall decisions on a case-by-case basis. However, there are some common reasons for issuing a recall:

• Risk of health problems: From time to time, further study reveals a connection between taking a drug and a potential health problem. For example, some pharmaceutical drugs carry an increased risk of heart attack, stroke, kidney failure, and other adverse reactions.
• Previously unknown drug interactions and adverse events: Mixing drugs can cause health problems. Sometimes, either the company or the FDA discovers a medication causes issues when taken with another drug, a specific type of vitamin, or certain foods.
• Manufacturing and packaging errors: Sometimes, the FDA or drug manufacturer learns that there's a problem at the factory. They may also identify a contamination problem that may make a drug unsafe for consumption. Sometimes, the company learns that a packaging error unseals a drug before it reaches the U.S. market.
• Failure to warn issues: Sometimes, a pharmaceutical company knows their drug poses certain health risks. When this is the case, they must warn patients and healthcare professionals of these risks. In these situations, the U.S. Food and Drug Administration will order that the drugmaker include a warning label on the drug's packaging and marketing materials.

Once the FDA or drug company determines it will issue a recall, it must follow steps to safeguard public health.

How a Recall Works

Usually, a manufacturer will initiate a voluntary recall for an unsafe drug. This may happen for a variety of reasons. Some of the more common reasons why a drug company would start a voluntary recall or market withdrawal include:

• The manufacturer receives an alarming number of reported problems from patients
• Research studies or clinical trials determine that a drug increases the risk of serious complications
• A problem at a manufacturing plant puts patients at risk
• New drugs are not tested sufficiently or adequately before drug approval
• Clinical trials fail to reveal specific rare side effects before FDA approval
• Participants in a clinical trial are healthier than the drug's patient population
• Improper labeling of drugs, such as lack of safety alerts, disclaimers, or warnings
• Problems with drug storage
• Illegal or unlawful behavior by drugmakers, such as including prescription medications in over-the-counter remedies

While these recalls are technically voluntary, in many cases they occur at the FDA's request.

Does the FDA Oversee the Recall Process?

The FDA works closely with the manufacturers of drug products during a recall. The agency maintains a database of product recalls for the public. It also assists manufacturers in retrieving their drugs from the market and the appropriate follow-up.

The agency utilizes a recall classification system to highlight the seriousness of the problem. In the USA, the FDA can issue a mandatory recall order for a pharmaceutical drug. While the FDA rarely exercises this power, the threat of it generally encourages manufacturers to take the necessary steps to remove a drug from the market until it resolves any safety issues.

Types of Product Recalls

The FDA classifies recalls based on the seriousness of the drug's risks. Some of the factors considered when determining whether to recall a drug include:

• Severity of the hazard
• Populations impacted by the potential risks (older adults, children, etc.)
• The probability of the danger occurring
• Number of potential victims
• Long-term and short-term consequences of the drug's potential hazards

After reviewing the above information, the drugmaker or FDA will decide into which class of recall a drug falls.

There are three categories of recalled products. They fall into the following three classes:

• Class I recall: Drugs that pose the most significant risk of injury or death
• Class II recall: Medications with lower potential to cause substantial harm or death
• Class III recall:  Drugs that are not likely to cause adverse health effects but still pose a slight chance

There are also times when a company issues a market withdrawal. The manufacturer pulls a product from the market with a minor violation not subject to FDA recall. These market withdrawals are not recalls.

With these withdrawals, the manufacturer doesn't ask patients to return existing drugs. Instead, the manufacturer stops distributing the medicine. They gradually remove a prescription 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. A manufacturer may also figure that a rise in product liability lawsuits will damage the brand and hurt the company's public image. Ceasing to sell a drug can remove it from the market without attracting the attention of an actual recall.

Examples of Drugs the FDA Has Recalled Over the Years

There are hundreds of new drugs introduced to the market every year. While drugmakers are supposed to investigate all new drugs before releasing them to the market, this doesn't always happen the way it should.

Some of the medications the FDA or drug manufacturers recalled for safety issues include:

• Meridia (sibutramine)
• Terfenadine
• Cerivastatin
• Blood pressure medications
• Cholesterol drugs

Drugmakers recalled these medications for a host of different reasons. Sadly, pharmaceutical companies don't recall most drugs until the FDA or drug manufacturers realize that it has injured hundreds or thousands of Americans. If this happens to you or your loved one, you should speak with a product liability attorney near you.

Need More Help? Consider Speaking With a Dangerous Drug Attorney

If you have been negatively affected by a drug, it's helpful to speak with an experienced product liability attorney with experience with drugs and medical devices for more help. Whether the drug has already been recalled or still poses a danger to the public, they can help with all related issues.

A local personal injury lawyer will meet with you for a free case evaluation. They'll let you know if you have a valid claim and, if so, help you pursue the drug manufacturer for damages.