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Encyclopedia > Black box warning

In the United States, a black box warning (also sometimes called a black label warning) is a type of warning that appears on prescription drugs that may cause serious adverse effects. It is so named for the black border that usually surrounds the text of the warning. Wikipedia does not have an article with this exact name. ... In the United States, a black box warning is a type of warning that appears on prescription drugs that may cause serious side effects. ... A prescription drug (or POM Prescription Only Medicine, in UK) is a licensed medicine that is regulated by legislation to require a prescription before it can be obtained. ... Adverse effect, in medicine, is an abnormal, harmful, undesired and/or unintended side-effect, although not necessarily unexpected, which is obtained as the result of a therapy or other medical intervention, such as drug/chemotherapy, physical therapy, surgery, medical procedure, use of a medical device, etc. ...


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. Adverse effect, in medicine, is an abnormal, harmful, undesired and/or unintended side-effect, although not necessarily unexpected, which is obtained as the result of a therapy or other medical intervention, such as drug/chemotherapy, physical therapy, surgery, medical procedure, use of a medical device, etc. ... The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating food (humans and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal) and radiation emitting devices (including non-medical devices), biologics, and... Pharmacology (in Greek: pharmacon is drug, and logos is science) is the study of how chemical substances interfere with living systems. ... A prescription drug (or POM Prescription Only Medicine, in UK) is a licensed medicine that is regulated by legislation to require a prescription before it can be obtained. ...


Black box warnings on drugs have received increased media attention in the United States in 2005. Among some of the more widely covered stories: 2005 (MMV) was a common year starting on Saturday of the Gregorian calendar. ...

  • 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 NSAID celecoxib (Celebrex®).
  • 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. [1]
  • As of the 9 October FDA have added Black Box to Warfarin the anticoagulant made by Bristol Mayers Squibb due to the risk of bleeding to death.
  • Some have pushed for a black box warning on ADHD medications due to possible severe psychological side-effects

A recent form of antidepressant medication - Prozac Serotonin-norepinephrine reuptake inhibitor, Venlafaxine An antidepressant, in the most common usage, is a medication taken to alleviate clinical depression or dysthymia (milder depression). ... Suicide (from Latin sui caedere, to kill oneself) is the willful act of killing oneself. ... “Children” redirects here. ... A separate article is about the punk band called The Adolescents. ... Pfizer, Incorporated (NYSE: PFE) (pronounced faɪzəɹ or faɪzə), is the worlds largest pharmaceutical company. ... Non-steroidal anti-inflammatory drugs, usually abbreviated to NSAIDs, are drugs with analgesic, antipyretic and anti-inflammatory effects - they reduce pain, fever and inflammation. ... Celecoxib (INN) (IPA: ) is a non-steroidal anti-inflammatory drug (NSAID) 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 adenomatous polyposis. ... This article is about the contraceptive injection. ... DISCLAIMER Please remember that Wikipedia is offered for informational use only. ...

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Black box warnings have not always found their way to the customer. While the warning is always printed on the wholesale bottles sold to pharmacies by the manufacturer, it is up to individual pharmacies to print the labels for the small retail bottles in which medicines are typically dispensed to the public. Most pharmacies create their labels with a computer program designed to handle all prescription drugs, but which has not yet been modified to print black warning boxes for a number of drugs with significant side effects or interactions. Image File history File links Information_icon. ... Shortcut: WP:WIN Wikipedia is an online encyclopedia and, as a means to that end, also an online community. ... Shortcut: WP:CU Marking articles for cleanup This page is undergoing a transition to an easier-to-maintain format. ... This Manual of Style has the simple purpose of making things easy to read by following a consistent format — it is a style guide. ... Image File history File links Unbalanced_scales. ...


Similarly, drug packages may come with a comprehenisve disclosure statement. While these statements contain important information, their expansiveness and small type are difficult for some to read. This disclosure is also reprinted in ads for prescriptions that appear in popular magazines, in addition to medical journals, as well as the Physician's Desk Reference. These disclosures are sometimes passed on to patients along with samples of new drugs, but not all doctors are so diligent--nor are all patients so curious. Pharmacists rarely give the disclosure to a customer buying a small retail prescription, in part because they only get one copy with each wholesale bottle, rather than the forty or fifty they would actually need, and it is nearly impossible to photocopy the small documents. Those patients whose doctors treat them from their sample cabinets will have many copies of these documents. Those patients who have the right kind of insurance to buy prescriptions for a nominal "copyment" will never see a disclosure. The latter group would appear to be larger than the former. The Physicians Desk Reference (PDR) is a commercially published compilation of manufacturers prescribing information on prescription drugs, updated annually. ...


External links

  • Black Box Warnings by FormWeb.

  Results from FactBites:
 
Black box warning - Wikipedia, the free encyclopedia (244 words)
A fl box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.
Black box warnings on drugs have received increased media attention in the United States in 2005.
The FDA has required that fl box warnings be placed on all antidepressant medications warning they may result in increased risk of suicidal tendencies in children and adolescents.
Black box - Wikipedia, the free encyclopedia (314 words)
Black box (systems), in electronics, a system in which only the input and output characteristics are of interest—without regard to its internal mechanism or structure.
Black Box (transportation), an informal name for the flight data recorder or cockpit voice recorder used in aircraft, the event recorder in railway equipment or the Event Data Recorder in automobiles.
Black box warning, a U.S. warning on a prescription drug that means it carries a significant risk of fatal side effects.
  More results at FactBites »

 
 

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