Black box warning

In the United States, a black box warning (also sometimes called a black label warning or boxed warning ) is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. It is so named for the black border that usually surrounds the text of the warning.

A black box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. The U.S. Food and Drug Administration (FDA) can require a pharmaceutical company to place a black box warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires.

Economists and physicians have thoroughly studied the effects of FDA black box warnings on prescription patterns. It is not necessarily true that a physician and patient will have a conversation about a drug's black box warning after it is issued. For instance, FDA black box warning decreased rosiglitazone use by 70% but that still means 3.8 million people were still given the drug. Later research indicates that after receiving an FDA advisory, there was a decrease in rosiglitazone use, due to a combined effect of media exposure, advisory, and scientific publications, whereas pioglitazone (with a similar advisory) did not similarly decrease in use. This challenges the idea that physicians and patients will have a conversation after a black box is issued. Throughout the country, black box warnings will be translated into prescription patterns differently by different physicians.

In 2005, the FDA issued a black box warning regarding the risk of atypical antipsychotics being prescribed among elderly patients with dementia. This advisory is associated with a decrease in use of antipsychotics, especially in elderly patients with dementia.

Examples
Black box warnings on drugs have received increased media attention in the United States since 2004. Among some of the more widely covered stories:
 * The FDA has required that black box warnings be placed on all antidepressant medications warning they may result in increased risk of suicidal tendencies in children and adolescents.
 * FDA advisors have recommended that Pfizer be required to place a black box warning on their non-steroidal anti-inflammatory drug Celebrex (celecoxib) for cardiovascular and gastrointestinal risks.
 * As of 17 November 2004, the FDA has required a black box warning on the Depo-Provera contraceptive injection, due to the risk of significant loss of bone density with long-term use.
 * As of October 9, 2006, the FDA added a black box warning to the anticoagulant warfarin due to the risk of bleeding to death.
 * In February 2006, the FDA's Drug Safety and Risk Management Advisory Committee voted to include black box warnings on methylphenidate formulations used to treat attention deficit hyperactivity disorder, such as Ritalin (methylphenidate), due to possible cardiovascular side-effects. A month later, the agency's Pediatric Advisory Committee effectively rejected recommending boxed warnings for both cardiovascular and psychiatric adverse effects. Minutes and transcripts of the relevant meetings are available on the FDA website.
 * On November 14, 2007, the FDA added a black box warning to the diabetes medication Avandia (rosiglitazone), citing the risk of heart failure or heart attack to patients with underlying heart disease, or are at a high heart attack risk.
 * On July 8, 2008, the FDA ordered a black box warning on certain antibiotic medications containing fluoroquinolone, which has been linked to tendon ruptures and tendinitis. Included were the popular drugs Cipro (ciprofloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin) and Floxin (ofloxacin).
 * As of July 1, 2009, the FDA requires Chantix (varenicline) to carry a black box warning due to public reports of side effects including depression, suicidal thoughts, and suicidal actions.
 * On October 27, 2010, the FDA issued a black box warning regarding the use of Metacam (meloxicam) oral suspension in cats in the United States. Meloxicam is a non-steroidal anti-inflammatory drug that is approved in the U.S. for a single post-operative injection in cats.