• A black box warning is one of the most stringent warnings imposed on prescription drugs by the FDA.
• Only the FDA can require drug labels to include a black box warning.
• A black box warning may limit a drug manufacturer’s liability in a failure-to-warn lawsuit.
• But drug manufacturers often resist the imposition of black box warnings because of the negative effect they have on sales.
A “boxed warning,” commonly referred to as a “black box warning,” appears on the label of certain prescription drugs. The black box warning is designed to call attention to serious or life-threatening risks. Many well-known and commonly used prescription drugs contain black box warnings, including:
• Prozac and other antidepressant medications
• The anticoagulants Warfarin and Pradaxa
• The diabetes drugs Avandia and Januvia
• Levaquin and other antibiotics containing fluoroquinolone
A black box warning is one of the most stringent warnings required by the FDA on a prescription drug.
Federal regulations provide:
Certain contraindications or serious warnings, particularly those that may lead to death or serious injury, may be required by the FDA to be presented in a box. The boxed warning ordinarily must be based on clinical data, but serious animal toxicity may also be the basis of a boxed warning in the absence of clinical data. The box must contain, in uppercase letters, a heading inside the box that includes the word “WARNING” and conveys the general focus of the information in the box. The box must briefly explain the risk and refer to more detailed information in the “Contraindications” or “Warnings and Precautions” section, accompanied by the identifying number for the section or subsection containing the detailed information.
21 CFR 201.57.
Many products liability lawsuits regarding prescription drugs allege that the drug manufacturer failed to warn of a certain risk. However, a plaintiff cannot bring a failure-to-warn lawsuit solely because the drug manufacturer failed to include a warning in a black box. Indeed, the FDA has stated that, “to ensure the significance of boxed warnings in drug labeling, they are permitted only when specifically required by FDA.” 44 Fed. Reg. 37434, 37448 (June 26, 1979).
On the other hand, black box warnings often limit the liability of drug manufacturers. It is almost impossible to bring a failure-to-warn claim regarding a warning included in a black box on the drug label. The products liability litigation regarding antidepressants and suicidal behavior is instructive on this issue.
In the early 2000s, hundreds of lawsuits were filed against antidepressant manufacturers. Plaintiffs alleged that the drugs were defective because they failed to include a warning regarding increased suicidal behavior in adolescents. In 2004, the FDA required drug manufacturers to include a black box on all antidepressants warning that adolescents treated with antidepressants are more likely to become suicidal. This warning was extended to include young adults in 2007. After 2004, litigation regarding the failure to warn of suicidal behavior ground to a halt.
This raises the question – why don’t more drug manufacturers seek to have black box warnings added to their products? The answer is that drug manufacturers fear black box warnings will scare off doctors from prescribing and patients from taking their drugs. In fact, drug manufacturers often resist FDA efforts to impose black box warnings because of the negative impact they have on sales.
Written by:
Linda K. Leibfarth
Watts Guerra LLP
4 Dominion Drive, Bldg. 3, Suite 100
San Antonio, Texas 78257
Phone (210) 447-0500
© Watts Guerra LLP 2015
