How Drugs Receive FDA Approval

The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is the watchdog agency that’s responsible for testing new medications before they are approved. Drug manufacturers seek approval from the FDA after they have conducted numerous clinical trials and submitted all of their data to the FDA for review. Drugs are approved only if the FDA believes the data supports the efficacy for the targeted indication and that the drugs’ risks are reasonable and manageable.

Drugs undergo an arduous development process on the route to receiving FDA approval. According to the FDA’s web site, “American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world.”

Warning About a Drug’s Risk

However, the FDA may approve drugs knowing that they have the potential for causing significant harm. In such situations, the FDA will approve a new drug with the stipulation that the medication’s label will include a warning about the particular risk. This is called a black box warning. The black box warning can be issued as part of the drug’s approval, or it can be added to the label after the drug has been marketed and used by consumers.

Drugs that include a black box warning generally carry higher potential danger than medications without the warning. The black box warnings are meant to alert physicians and patients to potential life-threatening, or very serious, side effects when the drug is used in some people.

The black box warning does not mean the drug always, or even usually, will produce the harmful side effects.

It is important to understand that all medicines are associated with some degree of risk to patients. However, doctors will prescribe even high risk medication when the potential for good sufficiently outweighs the potential for harm. This is particularly true when not prescribing the medication could potentially be worse for the patient than exposing the patient to the risk mentioned in the black box warning.

Understanding a Medication’s Risks

ConsumerSafety.org notes that “one third of newly approved drugs from the FDA have received an FDA action, recall, or ‘black box’ warning.” They have provided a list of medications with black box warnings. Please click here to view the list. If you, or someone you love, is taking one of these medications, you can find out why it has received a black box warning.

It is important to restate that a black box warning does not necessarily mean that taking the drug would be an unwise choice. In some situations, the risk of using the drug may outweigh the potential benefits.

This is true for all medications, not just those with a black box warning. But the decision of whether or not to use a medication must be based upon a discussion between the patient and their physicians. It is critical that all patients understand the risks of a particular medication prior to using it.

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