What is an FDA Black Box Warning?

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Not every pharmaceutical drug is safe for public consumption. When a prescription drug is proven to be effective for some patients, but can cause serious side effects in others, the Food and Drug Administration (FDA) will require the drug to contain a warning. This warning must be printed on inside the packaging and on the materials developed for the doctors who prescribe the drug.
The Black Box

This warning is called a “black box warning,” named after the bold black border drawn around the text. The border is designed to draw attention to the warning, and to set it apart from other information that may be included in other pharmaceutical labeling. Due to widespread public awareness of the implications of this warning, a black box on drug packaging serves as an alert that the drug is dangerous even before people read the text of the warning.

The Strongest There Is

A black box warning is the strongest warning the FDA can issue about a dangerous drug. It is just one step short of removing the drug from the market. Black box warnings recognize how harmful a drug can be if it’s given to patients who are at risk of developing the potentially harmful side effects.

How a Drug Receives This Warning

When a drug receives a black box warning, it means that studies conducted on the drug have suggested that it can cause dangerous or even deadly side effects. Black box warnings are often added in hindsight, as the result of information that has surfaced during routine usage. When doctors begin reporting high levels of dangerous side effects for a prescription drug, the FDA may hold a review to determine whether or not the drug requires a black box warning.

The FDA requires a black box warning for one of the following situations:

– The medication can cause serious detrimental effects (such as a fatal, life-threatening or permanently disabling adverse reaction) compared to the potential benefit from the medication. Depending on your health condition, you and your doctor would need to decide if the potential benefit from taking the drug is worth the risk.

– A severe adverse reaction can be prevented, reduced in frequency, or reduced in severity by properly using the prescription medication. For example, a drug may be safe to use for adults, but not for children.

Information Included in the Warning

The FDA requires a black box warning to provide a concise summary of the potentially harmful side effects and risks associated with taking the drug. You and your doctor must be aware of this information before you start using the drug. By fully understanding the side effects, you can make a better informed decision. You never want to take a drug with potentially deadly side effects without knowing what those side effects are and how to recognize them.

Medication Guides

Along with a black box warning, the FDA also requires drug manufacturing companies to create a medication guide that contains information for the public on how to safely use a given medication. These guides contain FDA-approved information that can help you avoid a serious adverse reaction.

These medication guides will be issued by your pharmacist at the time you have your prescription filled. The guides are also available online from the drug company and from the FDA. If your medication has been given a black box warning, ask your pharmacist for a printed copy of the medication guide.