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Boxed warning

Index Boxed warning

In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears on the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text. [1]

115 relations: ACE inhibitor, ACE inhibitor and thiazide combination, Adalimumab, Antidepressants and suicide risk, Aripiprazole, Atomoxetine, Attention deficit hyperactivity disorder management, Becaplermin, Bedaquiline, Bioidentical hormone replacement therapy, Black box (disambiguation), Boxed, Brentuximab vedotin, Bupropion, Bupropion/naltrexone, Cabozantinib, Canagliflozin, Child and adolescent psychiatry, Ciprofloxacin, Citalopram, Clozapine, COX-2 inhibitor, Criticism of the Food and Drug Administration, Dacarbazine, Darbepoetin alfa, Death of Conrad Roy, Delafloxacin, Denileukin diftitox, Dextropropoxyphene, Didanosine, Dronedarone, Duloxetine, Ecallantide, Eculizumab, Electronic Saviors Volume 2: Recurrence, Enoxaparin sodium, Epoetin alfa, Erythropoietin, Etanercept, Fenfluramine/phentermine, Fluoxetine, Fluvoxamine, Gabapentin, Gatifloxacin, Gemifloxacin, GlaxoSmithKline, Haloperidol, Hydroxyethyl starch, Idelalisib, Indoor tanning, ..., Inotuzumab ozogamicin, Isotretinoin, Lamotrigine, Leana Wen, Levofloxacin, Linaclotide, Lindane, Liothyronine, Lomefloxacin, Major depressive disorder, Management of Crohn's disease, Maraviroc, Medroxyprogesterone acetate, Mefloquine, Methamphetamine, Metoclopramide, Mifepristone, Mipomersen, Mirtazapine, Mometasone/formoterol, Naproxen, Natalizumab, Nevirapine, Nilotinib, Ofatumumab, Olanzapine, Olanzapine/fluoxetine, Ospemifene, Panitumumab, Patiromer, Perampanel, Peter Breggin, Pimecrolimus, Plague Recordings, Ponatinib, Prasugrel, Progestin-induced virilization, Promethazine, Quinolone antibiotic, Rivaroxaban, Rosiglitazone, Sarilumab, Selegiline, Sertraline, Sodium oxybate, Study 329, Stye, Telaprevir, Telithromycin, Terfenadine, Tetrabenazine, Tipranavir, Tofacitinib, Tolcapone, Trastuzumab emtansine, Treatment of Tourette syndrome, Tretinoin, Valganciclovir, Valproate, Valsartan, Varenicline, Venlafaxine, Wayne Goodman, Ziprasidone, Zolpidem. Expand index (65 more) »

ACE inhibitor

An angiotensin-converting-enzyme inhibitor (ACE inhibitor) is a pharmaceutical drug used primarily for the treatment of hypertension (elevated blood pressure) and congestive heart failure.

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ACE inhibitor and thiazide combination

An ACE inhibitor and thiazide combination is a drug combination used to treat hypertension.

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Adalimumab

Adalimumab, sold under the trade name Humira among others, is a medication used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa, and juvenile idiopathic arthritis.

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Antidepressants and suicide risk

The relationship between antidepressant use and suicide risk is the target of medical research.

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Aripiprazole

Aripiprazole, sold under the brand name Abilify among others, is an atypical antipsychotic. It is recommended and primarily used in the treatment of schizophrenia and bipolar disorder. Other uses include as an add-on treatment in major depressive disorder, tic disorders, and irritability associated with autism. According to a Cochrane review, evidence for the oral form in schizophrenia is not sufficient to determine effects on general functioning. Additionally, because many people dropped out of the medication trials before they were completed, the overall strength of the conclusions is low. Side effects include neuroleptic malignant syndrome, a movement disorder known as tardive dyskinesia, and high blood sugar in those with diabetes. In the elderly there is an increased risk of death. It is thus not recommended for use in those with psychosis due to dementia. It is pregnancy category C in the United States and category C in Australia, meaning there is possible evidence of harm to the fetus. It is not recommended for women who are breastfeeding. It is unclear whether it is safe or effective in people less than 18 years old. It is a partial dopamine agonist. Aripiprazole was developed by Otsuka in Japan. In the United States, Otsuka America markets it jointly with Bristol-Myers Squibb. From April 2013 to March 2014, sales of Abilify amounted to almost $6.9 billion.

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Atomoxetine

Atomoxetine, sold under the brand name Strattera among others, is a norepinephrine (noradrenaline) reuptake inhibitor which is approved for the treatment of attention deficit hyperactivity disorder (ADHD).

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Attention deficit hyperactivity disorder management

Attention deficit hyperactivity disorder management options are evidence-based practices with established treatment efficacy for ADHD.

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Becaplermin

Becaplermin (brand name Regranex) is a cicatrizant, available as a topical gel.

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Bedaquiline

Bedaquiline, sold under the brand name Sirturo, is a medication used to treat active tuberculosis.

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Bioidentical hormone replacement therapy

Bioidentical hormone replacement therapy (BHRT), also known as bioidentical hormone therapy or natural hormone therapy, is the use of hormones that are identical on a molecular level with endogenous hormones in hormone replacement therapy.

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Black box (disambiguation)

A black box is a device, object, or system whose inner workings are unknown; only the "stimuli inputs" and "output reactions" are known characteristics.

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Boxed

Boxed may refer to.

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Brentuximab vedotin

Brentuximab vedotin (INN, trade name Adcetris) is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL).

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Bupropion

Bupropion, sold under the brand names Wellbutrin and Zyban among others, is a medication primarily used as an antidepressant and smoking cessation aid.

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Bupropion/naltrexone

Bupropion/naltrexone is a combination drug used for weight loss in those that are either obese or overweight with some weight-related illnesses.

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Cabozantinib

Cabozantinib, sold under the brand-name Cabometyx and Cometriq, is a medication used to treat medullary thyroid cancer and a second line treatment for renal cell carcinoma among others.

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Canagliflozin

No description.

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Child and adolescent psychiatry

Child and adolescent psychiatry or pediatric psychiatry is a branch of psychiatry that focuses on the diagnosis, treatment, and prevention of mental disorders in children, adolescents, and their families.

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Ciprofloxacin

Ciprofloxacin is an antibiotic used to treat a number of bacterial infections.

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Citalopram

Citalopram (brand names: Celexa, Cipramil and others) is an antidepressant drug of the selective serotonin reuptake inhibitor (SSRI) class.

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Clozapine

Clozapine, sold under the brand name Clozaril among others, is an atypical antipsychotic medication.

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COX-2 inhibitor

Selective COX-2 inhibitors are a type of nonsteroidal anti-inflammatory drug (NSAID) that directly targets cyclooxygenase-2, COX-2, an enzyme responsible for inflammation and pain.

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Criticism of the Food and Drug Administration

Numerous governmental and non-governmental organizations have criticized the U. S. Food and Drug Administration for alleged excessive and/or insufficient regulation.

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Dacarbazine

Dacarbazine (DTIC), also known as imidazole carboxamide, is a chemotherapy medication used in the treatment of melanoma and Hodgkin's lymphoma.

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Darbepoetin alfa

Darbepoetin alfa (INN) is a re-engineered form of erythropoietin containing 5 amino acid changes (N30, T32, V87, N88, T90) resulting in the creation of 2 new sites for N-linked carbohydrate addition.

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Death of Conrad Roy

Conrad Henri Roy III (September 12, 1995 July 13, 2014) was an American marine salvage captain.

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Delafloxacin

Delafloxacin (INN) (trade name Baxdela) is a fluoroquinolone antibiotic used to treat acute bacterial skin and skin structure infections.

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Denileukin diftitox

Denileukin diftitox (trade name Ontak) was an antineoplastic agent, an engineered protein combining Interleukin-2 and Diphtheria toxin.

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Dextropropoxyphene

Dextropropoxyphene is an analgesic in the opioid category, patented in 1955 and manufactured by Eli Lilly and Company.

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Didanosine

Didanosine (ddI, DDI), marketed under the trade names Videx, is a medication used to treat HIV/AIDS.

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Dronedarone

Dronedarone (development codename SR33589 and marketed as Multaq) is a drug by Sanofi-Aventis, mainly for the indication of cardiac arrhythmias.

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Duloxetine

Duloxetine, sold under the brand name Cymbalta among others, is a medication mostly used for major depressive disorder, generalized anxiety disorder, fibromyalgia and neuropathic pain.

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Ecallantide

Ecallantide (trade name Kalbitor) is a drug used for the treatment of hereditary angioedema (HAE) and in the prevention of blood loss in cardiothoracic surgery.

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Eculizumab

Eculizumab, sold under the trade name Soliris, is a medication used to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

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Electronic Saviors Volume 2: Recurrence

Electronic Saviors Volume 2: Recurrence is the second Electronic Saviors cancer charity compilation compiled by Jim Semonik of Rein, a cancer survivor.

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Enoxaparin sodium

Enoxaparin sodium, sold under the brand name Lovenox among others, is an anticoagulant medication (blood thinner).

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Epoetin alfa

Epoetin alfa (rINN) is a human erythropoietin produced in cell culture using recombinant DNA technology.

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Erythropoietin

Erythropoietin (EPO), also known as hematopoietin or hemopoietin, is a glycoprotein cytokine secreted by the kidney in response to cellular hypoxia; it stimulates red blood cell production (erythropoiesis) in the bone marrow.

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Etanercept

Etanercept (trade name Enbrel) is a biopharmaceutical that treats autoimmune diseases by interfering with tumor necrosis factor (TNF, a soluble inflammatory cytokine) by acting as a TNF inhibitor.

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Fenfluramine/phentermine

The drug combination fenfluramine/phentermine, usually called fen-phen, was an anti-obesity treatment that utilized two anorectics.

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Fluoxetine

Fluoxetine, also known by trade names Prozac and Sarafem, among others, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class.

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Fluvoxamine

Fluvoxamine, sold under the brand name Luvox among others, is a medication which is used primarily for the treatment of obsessive–compulsive disorder (OCD), and is also used to treat major depressive disorder and anxiety disorders such as panic disorder and post-traumatic stress disorder.

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Gabapentin

Gabapentin, sold under the brand name Neurontin among others, is a medication which is used to treat epilepsy (specifically partial seizures), neuropathic pain, hot flashes, and restless legs syndrome.

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Gatifloxacin

Gatifloxacin sold under the brand names Gatiflo, Tequin and Zymar, is an antibiotic of the fourth-generation fluoroquinolone family, that like other members of that family, inhibits the bacterial enzymes DNA gyrase and topoisomerase IV.

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Gemifloxacin

Gemifloxacin mesylate (trade name Factive, Oscient Pharmaceuticals) is an oral broad-spectrum quinolone antibacterial agent used in the treatment of acute bacterial exacerbation of chronic bronchitis and mild-to-moderate pneumonia.

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GlaxoSmithKline

GlaxoSmithKline plc (GSK) is a British pharmaceutical company headquartered in Brentford, London.

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Haloperidol

Haloperidol, marketed under the trade name Haldol among others, is a typical antipsychotic medication.

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Hydroxyethyl starch

Hydroxyethyl starch (HES/HAES), sold under the brand name Voluven among others, is a nonionic starch derivative, used as a volume expander in intravenous therapy.

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Idelalisib

Idelalisib (trade name Zydelig, codenamed GS-1101 or CAL-101) is a drug used for the treatment of certain hematological malignancies.

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Indoor tanning

Indoor tanning involves using a device that emits ultraviolet radiation to produce a cosmetic tan.

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Inotuzumab ozogamicin

Inotuzumab ozogamicin (trade name Besponsa) is an antibody-drug conjugate used to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

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Isotretinoin

Isotretinoin, also known as 13-cis-retinoic acid (and colloquially referred to by its former brand name Accutane or Roaccutane), is a medication primarily used to treat severe acne.

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Lamotrigine

Lamotrigine, sold as the brand name Lamictal among others, is an anticonvulsant medication used to treat epilepsy and bipolar disorder.

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Leana Wen

Leana Sheryle Wen (born January 27, 1983), --> is a physician, public health advocate, --> and the health commissioner of Baltimore City, Maryland, USA.

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Levofloxacin

Levofloxacin, sold under the trade names Levaquin among others, is an antibiotic.

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Linaclotide

Linaclotide (marketed under the trade name Linzess in the US and Mexico, and as Constella elsewhere) is a drug used to treat irritable bowel syndrome with constipation and chronic constipation with no known cause.

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Lindane

Lindane, also known as gamma-hexachlorocyclohexane (γ-HCCH), gammaxene, Gammallin and sometimes incorrectly called benzene hexachloride (BHC), is an organochlorine chemical variant of hexachlorocyclohexane that has been used both as an agricultural insecticide and as a pharmaceutical treatment for lice and scabies.

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Liothyronine

Liothyronine is a synthetic form of triiodothyronine (T3), a thyroid hormone used to treat hypothyroidism and myxedema coma.

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Lomefloxacin

Lomefloxacin hydrochloride (sold under the following brand names in English speaking countries Maxaquin, Okacyn, Uniquin) is a fluoroquinolone antibiotic used to treat bacterial infections including bronchitis and urinary tract infections.

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Major depressive disorder

Major depressive disorder (MDD), also known simply as depression, is a mental disorder characterized by at least two weeks of low mood that is present across most situations.

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Management of Crohn's disease

Management of Crohn's disease involves first treating the acute symptoms of the disease, then maintaining remission.

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Maraviroc

Maraviroc (INN, brand-named Selzentry, or Celsentri outside the U.S.) is an antiretroviral drug in the CCR5 receptor antagonist class used in the treatment of HIV infection.

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Medroxyprogesterone acetate

Medroxyprogesterone acetate (MPA), sold under the brand name Depo-Provera among others, is a hormonal medication of the progestin type.

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Mefloquine

Mefloquine, sold under the brand names Lariam among others, is a medication used to prevent or treat malaria.

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Methamphetamine

Methamphetamine (contracted from) is a potent central nervous system (CNS) stimulant that is mainly used as a recreational drug and less commonly as a second-line treatment for attention deficit hyperactivity disorder and obesity.

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Metoclopramide

Metoclopramide is a medication used mostly for stomach and esophageal problems.

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Mifepristone

Mifepristone, also known as RU-486, is a medication typically used in combination with misoprostol, to bring about an abortion.

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Mipomersen

Mipomersen (INN; trade name Kynamro) is used to treat homozygous familial hypercholesterolemia and is administered by subcutaneous injection.

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Mirtazapine

Mirtazapine, sold under the brand name Remeron among others, is an atypical antidepressant which is used primarily in the treatment of depression.

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Mometasone/formoterol

Mometasone/formoterol is a combination inhaler containing both an inhaled corticosteroid and long-acting bronchodilator.

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Naproxen

Naproxen (brand names: Aleve, Naprosyn, and many others) is a nonsteroidal anti-inflammatory drug (NSAID) of the propionic acid class (the same class as ibuprofen) that relieves pain, fever, swelling, and stiffness.

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Natalizumab

Natalizumab is a humanized monoclonal antibody against the cell adhesion molecule α4-integrin.

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Nevirapine

Nevirapine (NVP), marketed under the trade name Viramune among others, is a medication used to treat and prevent HIV/AIDS, specifically HIV-1.

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Nilotinib

Nilotinib (AMN107, trade name Tasigna), in the form of the hydrochloride monohydrate salt, is a small-molecule tyrosine kinase inhibitor approved for the treatment of imatinib-resistant chronic myelogenous leukemia.

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Ofatumumab

Ofatumumab (trade name Arzerra, also known as HuMax-CD20) is a fully human monoclonal antibody (for the CD20 protein) which appears to inhibit early-stage B lymphocyte activation.

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Olanzapine

Olanzapine (originally branded Zyprexa) is an antipsychotic medication used to treat schizophrenia and bipolar disorder.

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Olanzapine/fluoxetine

Olanzapine/fluoxetine (trade name Symbyax, created by Eli Lilly and Company) is a single capsule containing the atypical antipsychotic olanzapine and the selective serotonin reuptake inhibitor (SSRI) fluoxetine.

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Ospemifene

Ospemifene (brand name Osphena produced by Shionogi) is an oral medication indicated for the treatment of dyspareuniapain during sexual intercourseencountered by some women, more often in those who are post-menopausal.

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Panitumumab

Panitumumab (INN), formerly ABX-EGF, is a fully human monoclonal antibody specific to the epidermal growth factor receptor (also known as EGF receptor, EGFR, ErbB-1 and HER1 in humans).

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Patiromer

Patiromer (USAN, trade name Veltassa) is a drug used for the treatment of hyperkalemia (elevated blood potassium levels), a condition that may lead to palpitations and arrhythmia (irregular heartbeat).

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Perampanel

Perampanel (sold under the trade name Fycompa) is an antiepileptic drug developed by Eisai Co. that is used in addition to other drugs to treat partial seizures and generalized tonic-clonic seizures for people older than 12 years.

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Peter Breggin

Peter Roger Breggin (born May 11, 1936) is an American psychiatrist and critic of shock treatment and psychiatric medication.

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Pimecrolimus

Pimecrolimus is an immunomodulating agent of the calcineurin inhibitor class used in the treatment of atopic dermatitis (eczema).

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Plague Recordings

Plague Recordings (also known as Plague) is an independent record label formerly operating from Belgium specialising in ambient, industrial and experimental electronic music.

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Ponatinib

Ponatinib (trade name Iclusig, previously AP24534) is an oral drug developed by ARIAD Pharmaceuticals for the treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL).

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Prasugrel

Prasugrel (trade name Effient in the US and India, and Efient in the EU) is a drug used to prevent formation of blood clots.

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Progestin-induced virilization

Maternal use of androgens or high doses of certain weakly androgenic synthetic progestogens (progestins) structurally related to testosterone can masculinize (virilize) the external genitalia of a female fetus during susceptible times in pregnancy.

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Promethazine

Promethazine is a neuroleptic medication and first-generation antihistamine of the phenothiazine family.

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Quinolone antibiotic

A quinolone antibiotic is any member of a large group of broad-spectrum bactericides that share a bicyclic core structure related to the compound 4-quinolone.

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Rivaroxaban

Rivaroxaban, sold under the brand name Xarelto, among others, is an oral anticoagulant medication (blood thinner).

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Rosiglitazone

Rosiglitazone (trade name Avandia) is an antidiabetic drug in the thiazolidinedione class.

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Sarilumab

Sarilumab (trade name Kevzara) is a human monoclonal antibody against the interleukin-6 receptor.

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Selegiline

Selegiline, also known as L-deprenyl, is a substituted phenethylamine.

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Sertraline

Sertraline, sold under the trade names Zoloft among others, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class.

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Sodium oxybate

Sodium oxybate is a prescription medication used to treat two symptoms of narcolepsy: sudden muscle weakness and excessive daytime sleepiness.

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Study 329

Study 329 was a clinical trial conducted in North America from 1994 to 1998 to study the efficacy of paroxetine, an SSRI anti-depressant, in treating 12- to 18-year-olds diagnosed with major depressive disorder.

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Stye

A stye, also known as a hordeolum, is a bacterial infection of an oil gland in the eyelid.

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Telaprevir

Telaprevir (VX-950), marketed under the brand names Incivek and Incivo, is a pharmaceutical drug for the treatment of hepatitis C co-developed by Vertex Pharmaceuticals and Johnson & Johnson.

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Telithromycin

Telithromycin is the first ketolide antibiotic to enter clinical use and is sold under the brand name of Ketek.

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Terfenadine

Terfenadine is an antihistamine formerly used for the treatment of allergic conditions.

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Tetrabenazine

Tetrabenazine is a drug for the symptomatic treatment of hyperkinetic movement disorders.

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Tipranavir

Tipranavir (TPV), or tipranavir disodium, is a nonpeptidic protease inhibitor (PI) manufactured by Boehringer Ingelheim under the trade name Aptivus.

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Tofacitinib

Tofacitinib, sold under the brand Xeljanz among others, is a medication used to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.

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Tolcapone

Tolcapone (brand name Tasmar) is a drug used to treat Parkinson's disease (PD).

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Trastuzumab emtansine

Trastuzumab emtansine also known as ado-trastuzumab emtansine and sold under the trade name Kadcyla, is an antibody-drug conjugate consisting of the monoclonal antibody trastuzumab (Herceptin) linked to the cytotoxic agent emtansine (DM1).

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Treatment of Tourette syndrome

Tourette syndrome (also Tourette's syndrome or TS) is an inherited neuropsychiatric disorder with onset in childhood, characterized by the presence of motor and phonic tics.

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Tretinoin

Tretinoin, also known as all-trans retinoic acid (ATRA), is medication used for the treatment of acne and acute promyelocytic leukemia.

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Valganciclovir

Valganciclovir, sold under the brandname Valcyte among others, is an antiviral medication used to treat cytomegalovirus (CMV) infection in those with HIV/AIDS or following organ transplant.

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Valproate

Valproate (VPA), and its valproic acid, sodium valproate, and valproate semisodium forms, are medications primarily used to treat epilepsy and bipolar disorder and to prevent migraine headaches.

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Valsartan

Valsartan (trade name Diovan) is mainly used for treatment of high blood pressure, congestive heart failure, and to increase the chances of living longer after a heart attack.

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Varenicline

Varenicline (trade name Chantix and Champix), is a prescription medication used to treat nicotine addiction.

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Venlafaxine

Venlafaxine, sold under the brand name Effexor among others, is an antidepressant of the selective serotonin-norepinephrine reuptake inhibitor (SNRI) class.

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Wayne Goodman

Wayne Goodman is an American psychiatrist and researcher who specializes in Obsessive-Compulsive Disorder (OCD).

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Ziprasidone

Ziprasidone, sold under the brand name Geodon among others, is an atypical antipsychotic which is used for the treatment of schizophrenia as well as acute mania and mixed states associated with bipolar disorder.

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Zolpidem

Zolpidem, sold under the brand name Ambien, among others, is a sedative primarily used for the treatment of trouble sleeping.

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Redirects here:

Black Box Warning, Black Box Warnings, Black box warning, Black box warnings, Black-box warning.

References

[1] https://en.wikipedia.org/wiki/Boxed_warning

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