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FDA Types of Warnings Boxes

The United States Food and Drug Administration (FDA) is entrusted with making sure that products and prescription drugs are safe for human use. Many prescription drugs have a slew of potentially devastating side effects, and it is up to the FDA to protect the public. The FDA has developed a specific kind of warning for drugs with very serious side effects.

  1. Boxed Warnings

    • The FDA has a lot of power when it comes to regulating prescription drugs. If the FDA determines a particular drug is too dangerous, it pulls that drug from the market. If a drug is not quite dangerous enough to warrant removing it from shelves, the next most severe step is to issue a boxed warning for that drug, also known as a "black-box warning." All boxed warnings indicate the same high level of danger for patients.

    Reasons

    • The FDA issues boxed warning for three reasons. If a drug has severe side effects like potentially fatal or disabling reactions, a boxed warning is almost always issued. Another reason is when a drug has very specific usage instructions that drastically reduce the danger of potential side effects. For example, if a drug is only dangerous when combined with another drug or when used with a certain frequency, then the FDA often still issues a boxed warning. Finally, the FDA considers a boxed warning if a certain demographic is particularly at risk with a certain drug, such as those under 21.

    Purpose

    • Rather than focusing on informing the public, the purpose of boxed warnings is really to inform health care professionals, doctors and pharmacists as to the dangers of a particular drug. Often, boxed warnings contain information essential to determining whether or not a specific patient is able to safely use a drug. By consulting the boxed warning, a physician quickly and easily sees the dangers of a particular drug and assesses whether or not it is appropriate for the patient.

    Format and Appearance

    • If the FDA deems that a certain drug requires a boxed warning, this means a couple of things. The drug company is to include written warnings on the drug's packaging that lists, in a clear and concise manner, the potential side effects and the ways to avoid risk. This information is to be listed on the outside of the packaging itself, on the insert inside the drug's packaging, and on any literature or article advertising the drug. Additionally, a thick black line is to enclose this information, meant to make the warning stand out.

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