A Black Box Label is the strongest warning the Food and Drug Administration can impose on a pharmaceutical.
This type of strong warning was imposed on antidepressant manufacturers because these drugs may cause suicidal thoughts and/or behavior in some children and teens.
The warning looks like this:
*Code of Federal Regulations, Title 21, part 201,
Labeling:
Special problems, particularly those that may lead to death or serious injury, may be required by the Food and Drug Administration to be placed in a prominently displayed box. The boxed warning ordinarily shall be based on clinical data, but serious animal toxicity may also be the basis of a boxed warning in the absence of clinical data. If a boxed warning is required, its location will be specified by the Food and Drug Administration…
This warning can be found on many other drugs that have been approved by the FDA, so its important to understand that this label doesn’t mean that you shouldn’t use it, but that you should just be cautious of its side effects.
Some drugs with black box labels or proposed labels include:
1. antidepressants like Prozac
2. prescription non-steroidal anti-inflammatory drugs (NSAIDs) like Celebrex
3. eczema creams like Elidel and Protopic
*source: Food and Drug Administration
