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Black Box Warning Overview
The U.S. Food and Drug Administration (FDA) requires a “black box” or boxed warning when it detemines that a medication poses serious and even life-threatening risks to patients. The purpose is to inform prescribing doctors and their patients of potentially serious side effects. The primary reason for a black box warning is to provide information that assists patients and their physicians in weighing the benefits against the dangers of a particular medication.
A black box warning typically contains the following information:
- potential side effects
- known interactions with other medications
- dosing instructions
- patient monitoring
- who should and should not take the medication
Black box warnings can be applied to a single medication, or an entire class of drugs, such as SGLT inhitors or angiotensin receptor blockers (ARBs).
How and When a Black Box Warning is Required
A black box warning can be required as a condition of the initial approval when clinical studies and safety testing results indicate serious or life-threatening risks. More often, however, the FDA orders such warnings after post-marketing studies or adverse event reports have been submitted. The FDA may receive adverse event reports from a drug’s manufacturer, a prescribing doctor or other health care provider, or by patients themselves. Reports may be submitted through the FDA’s website.
Legal Issues
In recent years, there has been a significant increase in the number of prescription medications that have been required to carry black box warnings. However, there is growing concern that prescribing physicians are not heeding these warnings as vigilantly as they could. Recent lawsuits also indicate that pharmaceutical companies have been negligent when it comes to post-marketing studies, when side-effects and dangers that may not have been apparent during clinical trials can surface. In such cases, plaintiffs claim that the drug makers had an obligation to keep track of the risks associated with their products and submit reports to the FDA. Many lawsuits accuse drug companies of withholding this information after becoming aware of it so that revenues are not impacted.
In some cases, prescribing doctors are encouraged to disregard a black box warning by the drug company. This is one of the claims in lawsuits over amiodarone, a medication prescribed for various types of arrhythmia. Also known as Cordarone among other names, amiodarone has been associated with numerous serious side effects that include injuries to the lungs, liver, kidney and heart as well as neuropathy (nerve damage) and an inflammation of the optic nerve known as optic neuritis, according to the Mayo Clinic.
Because of this, the FDA has warned that amiodarone should be used only as a treatment of last resort. However, drug companies have allegedly been encouraging doctors to use it as a first-line treatment as well as for “off-label” purposes.
Lawsuits and Settlements
Plaintiffs who have suffered from side effects before those risks were noted on a black box warning have successfully sued drug companies or negligence, failure to warn and even wrongful death. Antidepressants, diabetic drugs and anticoagulants are common examples of drug companies that were held liable for failing to publicly acknowledge the dangers of these products.
