Black box warning
Encyclopedia
In the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...

, 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
Package insert
A package insert or prescribing information is a document provided along with a prescription medication to provide additional information about that drug.-Responsible agencies:In the United States, the Food and Drug Administration determines the requirements...

 for prescription drug
Prescription drug
A prescription medication is a licensed medicine that is regulated by legislation to require a medical prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription...

s that may cause serious adverse effect
Adverse effect
In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as surgery.An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. If it results from an unsuitable or incorrect dosage or...

s. 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 effect
Adverse effect (medicine)
In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as surgery.An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. If it results from an unsuitable or incorrect dosage or...

s. The U.S. Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

 (FDA) can require a pharmaceutical company to place a black box warning on the labeling of a prescription drug
Prescription drug
A prescription medication is a licensed medicine that is regulated by legislation to require a medical prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription...

, 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
Rosiglitazone
Rosiglitazone is an antidiabetic drug in the thiazolidinedione class of drugs. It works as an insulin sensitizer, by binding to the PPAR receptors in fat cells and making the cells more responsive to insulin...

 use by 70% but that still means 3.8 million people were 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
Pioglitazone
Pioglitazone is a prescription drug of the class thiazolidinedione with hypoglycemic action.Pioglitazone is marketed as trademarks Actos in the USA, Canada, the UK and Germany, Glustin in Europe,"Glizone" and "Pioz" in India by Zydus CND and USV respectively and Zactos in Mexico by Takeda...

 (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 antipsychotic
Atypical antipsychotic
The atypical antipsychotics are a group of antipsychotic tranquilizing drugs used to treat psychiatric conditions. Some atypical antipsychotics are FDA approved for use in the treatment of schizophrenia...

s 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
    Antidepressant
    An antidepressant is a psychiatric medication used to alleviate mood disorders, such as major depression and dysthymia and anxiety disorders such as social anxiety disorder. According to Gelder, Mayou &*Geddes people with a depressive illness will experience a therapeutic effect to their mood;...

     medications warning they may result in increased risk of suicidal tendencies in child
    Child
    Biologically, a child is generally a human between the stages of birth and puberty. Some vernacular definitions of a child include the fetus, as being an unborn child. The legal definition of "child" generally refers to a minor, otherwise known as a person younger than the age of majority...

    ren and adolescents.
  • FDA advisors have recommended that Pfizer
    Pfizer
    Pfizer, Inc. is an American multinational pharmaceutical corporation. The company is based in New York City, New York with its research headquarters in Groton, Connecticut, United States...

     be required to place a black box warning on their non-steroidal anti-inflammatory drug
    Non-steroidal anti-inflammatory drug
    Nonsteroidal anti-inflammatory drugs, usually abbreviated to NSAIDs or NAIDs, but also referred to as nonsteroidal anti-inflammatory agents/analgesics or nonsteroidal Anti-inflammatory medicines , are drugs with analgesic and antipyretic effects and which have, in higher doses, anti-inflammatory...

     Celebrex (celecoxib
    Celecoxib
    Celecoxib INN is a sulfa non-steroidal anti-inflammatory drug and selective COX-2 inhibitor used in the treatment of osteoarthritis, rheumatoid arthritis, acute pain, painful menstruation and menstrual symptoms, and to reduce numbers of colon and rectum polyps in patients with familial...

    ) 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
    Bone density
    Bone density is a medical term normally referring to the amount of mineral matter per square centimeter of bones. Bone density is used in clinical medicine as an indirect indicator of osteoporosis and fracture risk.This medical bone density is not the true physical "density" of the bone, which...

     with long-term use.
  • As of October 9, 2006, the FDA added a black box warning to the anticoagulant warfarin
    Warfarin
    Warfarin is an anticoagulant. It is most likely to be the drug popularly referred to as a "blood thinner," yet this is a misnomer, since it does not affect the thickness or viscosity of blood...

     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
    Methylphenidate
    Methylphenidate is a psychostimulant drug approved for treatment of attention-deficit hyperactivity disorder, postural orthostatic tachycardia syndrome and narcolepsy. It may also be prescribed for off-label use in treatment-resistant cases of lethargy, depression, neural insult and obesity...

     formulations used to treat attention deficit hyperactivity disorder, such as Ritalin (methylphenidate
    Methylphenidate
    Methylphenidate is a psychostimulant drug approved for treatment of attention-deficit hyperactivity disorder, postural orthostatic tachycardia syndrome and narcolepsy. It may also be prescribed for off-label use in treatment-resistant cases of lethargy, depression, neural insult and obesity...

    ), 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
    Rosiglitazone
    Rosiglitazone is an antidiabetic drug in the thiazolidinedione class of drugs. It works as an insulin sensitizer, by binding to the PPAR receptors in fat cells and making the cells more responsive to insulin...

    ), citing the risk of heart failure or heart attack to patients with underlying heart disease
    Heart disease
    Heart disease, cardiac disease or cardiopathy is an umbrella term for a variety of diseases affecting the heart. , it is the leading cause of death in the United States, England, Canada and Wales, accounting for 25.4% of the total deaths in the United States.-Types:-Coronary heart disease:Coronary...

    , 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
    Tendon
    A tendon is a tough band of fibrous connective tissue that usually connects muscle to bone and is capable of withstanding tension. Tendons are similar to ligaments and fasciae as they are all made of collagen except that ligaments join one bone to another bone, and fasciae connect muscles to other...

     ruptures and tendinitis. Included were the popular drugs Cipro (ciprofloxacin
    Ciprofloxacin
    Ciprofloxacin is a synthetic chemotherapeutic antibiotic of the fluoroquinolone drug class.It is a second-generation fluoroquinolone antibacterial. It kills bacteria by interfering with the enzymes that cause DNA to rewind after being copied, which stops synthesis of DNA and of...

    ), Levaquin (levofloxacin
    Levofloxacin
    Levofloxacin is a synthetic chemotherapeutic antibiotic of the fluoroquinolone drug class and is used to treat severe or life-threatening bacterial infections or bacterial infections that have failed to respond to other antibiotic classes. It is sold under various brand names, such as Levaquin and...

    ), Avelox (moxifloxacin
    Moxifloxacin
    Moxifloxacin is a fourth-generation synthetic fluoroquinolone antibacterial agent developed by Bayer AG . It is marketed worldwide under the brand names Avelox, Avalox, and Avelon for oral treatment. In most countries, the drug is also available in parenteral form for intravenous infusion...

    ), Noroxin (norfloxacin
    Norfloxacin
    Norfloxacin is a synthetic chemotherapeutic antibacterial agent occasionally used to treat common as well as complicated urinary tract infections. It is sold under various brand names with the most common being Noroxin. In form of ophthalmic solutions it is known as Chibroxin...

    ) and Floxin (ofloxacin
    Ofloxacin
    Ofloxacin is a synthetic chemotherapeutic antibiotic of the fluoroquinolone drug class considered to be a second-generation fluoroquinolone. The original brand, Floxin, has been discontinued by the manufacturer in the United States on 18 June 2009, though generic equivalents continue to be...

    ).
  • 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
    Meloxicam
    Meloxicam is a nonsteroidal anti-inflammatory drug with analgesic and fever reducer effects. It is a derivative of oxicam, closely related to piroxicam, and falls in the enolic acid group of NSAIDs...

    ) oral suspension in cat
    Cat
    The cat , also known as the domestic cat or housecat to distinguish it from other felids and felines, is a small, usually furry, domesticated, carnivorous mammal that is valued by humans for its companionship and for its ability to hunt vermin and household pests...

    s in the United States. Meloxicam is a non-steroidal anti-inflammatory drug
    Non-steroidal anti-inflammatory drug
    Nonsteroidal anti-inflammatory drugs, usually abbreviated to NSAIDs or NAIDs, but also referred to as nonsteroidal anti-inflammatory agents/analgesics or nonsteroidal Anti-inflammatory medicines , are drugs with analgesic and antipyretic effects and which have, in higher doses, anti-inflammatory...

     that is approved in the U.S. for a single post-operative injection in cats.
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