What is a Black Label Warning?
Short of removing a drug from the market entirely, a Boxed Warning—also called a Black Label Warning or Black Box Warning—is the harshest restriction the Food and Drug Administration, or FDA, can place on a commercial drug product. These warning are used to notify consumers that the drug carries a significant risk of serious and sometimes life-threatening side effects.
3 Factors Leading to Black Box Warnings
There are three conditions that the FDA uses to determine whether a drug will receive a boxed warning, and any one of them is sufficient to receive the classification. These three factors include:
- The drug has an adverse reaction which is life-threatening or permanently disabling, potentially outweighing the benefit received from the drug.
- The drug causes an adverse reaction that can be mitigated by appropriate use of the drug such as avoiding certain simultaneous treatments, adding another drug, or careful monitoring.
- The drug was only approved by the FDA with certain restrictions due to it only being safe if used in certain situations or frequencies.
The most common reason for a product to receive the black label warning is the presence of a serious, potentially life-threatening side effect, such as the case with Reglan. While Reglan can effectively treat heartburn caused by gastroesophageal reflux disease, it has been clearly linked to the development of neuromuscular disorders such as tardive dyskinesia and tardive dystonia.
Contact Us
If you or a loved one is living with a disability caused by the use of Reglan, you may be entitled to compensation for your resulting medical bills. Call an experienced Reglan lawsuit lawyer at Williams Kherkher today at 800-761-3187 today to schedule a consultation.
