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Black Box Warning on Pharmaceuticals

When the Food and Drug Administration (FDA) approves a New Drug Application (NDA) for a medication they also approve the accompanying Package Insert (PI sheet). The PI Sheet contains information about the chemical formula, disease indications, dosage and adverse effects of the new drug.

The sponsoring company is required to constantly monitor its medication for both safety and efficacy for as long as it is being used. Since drug testing usually only involves several thousand test patients, rare side effects may not be seen during the drug trials. The sponsor is responsible for monitoring these rare side effects and notifying the FDA of their occurrence.

Occasionally rare but very serious adverse effects come to the notice of the pharmaceutical company. Sometimes, in the opinion of the FDA, these rare but serious effects do not mandate removal of the product from the market but do require notification to the prescribers. To insure that these potentially severe untoward effects are brought to the attention of the prescribers the FDA mandates a warning be published in the PI Sheet. To emphasize the concern, this warning is separated from the other warnings, cautions and alerts and surrounded in the PI sheet by a Black Box border around the text. This is designed to catch the attention of all concerned: prescribers; pharmacists; and the public. The FDA makes this warning because the drug carries a significant risk of serious or possibly even life-threatening adverse effects. Because the warning is boxed off from the rest by of the PI Sheet by a black ink border it is called a "Black Box Warning" or a "Black Label Warning."

How It's Used

“Last year, the Food and Drug Administration required Depo-Provera's manufacturer Pfizer Inc. to place a ‘black box’ warning on the drug stating that women face an increased risk of bone loss the longer they use it. Bone loss increases risks for fractures and osteoporosis.”

"The Food and Drug Administration will require two smoking-cessation drugs, Chantix and Zyban, to carry the agency's strongest safety warning over side effects including depression and suicidal thoughts.

"The new requirement, called a 'Black Box' warning, is based on reports of people experiencing unusual changes in behavior, becoming depressed, or having suicidal thoughts while taking the drugs."

"New entrants in this market, however, will be dealing with a regulatory backlash that began last May. The FDA, having received more than 20 reports of testosterone in commercial products rubbing off on children, required that dreaded'black box' warnings be added to the labels for AndroGel and Auxilium's rival product, Testim. The companies put boldfaced warnings on all their packaging and marketing material, and they had to produce new package inserts instructing patients to wash their hands thoroughly after applying the gels."

"Attention, self-conscious geezers: The Brooklyn-based Mac games gurus at Freeverse (www.freeverse.com) have created an iPhone application to replace those magnifying eyeglasses you've been trying to ignore while waiting for your prescriptions at CVS. The app, called Eye Glasses, is a small-type buster, a magnifier that reveals the secrets hidden in black-box warning labels on medicine bottles and the ingredients in Trader Joe's goodies."

"Christopher Loder, a Pfizer spokesman, said the company filed a motion last week asking the panel or the full appellate court to review that decision. The hormonal drugs are still used by millions of women to treat symptoms of menopause. But after estrogen was linked to breast cancer in 2002 by a federally financed research effort, the Women's Health Initiative, the Food and Drug Administration added black-box warnings to the drugs' labels, cautioning that they be used at the smallest possible doses for the shortest possible time."

Also Known As (AKA)

Black Label Warning

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