PedAM
Pediatric Disease Annotations & Medicines
| neuroleptic malignant syndrome | ||||
| Disease ID | 273 |
|---|---|
| Disease | neuroleptic malignant syndrome |
| Definition | A potentially fatal syndrome associated primarily with the use of neuroleptic agents (see ANTIPSYCHOTIC AGENTS) which are in turn associated with dopaminergic receptor blockade (see RECEPTORS, DOPAMINE) in the BASAL GANGLIA and HYPOTHALAMUS, and sympathetic dysregulation. Clinical features include diffuse MUSCLE RIGIDITY; TREMOR; high FEVER; diaphoresis; labile blood pressure; cognitive dysfunction; and autonomic disturbances. Serum CPK level elevation and a leukocytosis may also be present. (From Adams et al., Principles of Neurology, 6th ed, p1199; Psychiatr Serv 1998 Sep;49(9):1163-72) |
| Synonym | malignant neuroleptic malignant neuroleptic syndrome neuroleptic malgnt synd neuroleptic malignant neuroleptic malignant syndrome (disorder) neuroleptic malignant syndrome -retired- neuroleptic malignant syndrome [disease/finding] neuroleptic malignant syndromes nms nms (neuroleptic malignant syndrome) nms - neuroleptic malignant syndrome nmss (neuroleptic malignant syndrome) syndrome, neuroleptic malignant syndromes, neuroleptic malignant |
| Orphanet | |
| DOID | |
| ICD10 | |
| UMLS | C0027849 |
| MeSH | |
| SNOMED-CT | |
| Comorbidity | UMLS | Disease | Sentences' Count(Total Sentences:10) C0024591 | malignant hyperthermia | 1 C0497327 | dementia | 1 C0011570 | depression | 1 C0014038 | encephalitis | 1 C0752347 | dementia with lewy bodies | 1 C0153349 | tongue cancer | 1 C0027145 | myxedema | 1 C0024586 | serotonin syndrome | 1 C0005586 | bipolar affective disorder | 1 C0020179 | huntington's disease | 1 |
| Curated Gene | (Waiting for update.) |
| Inferring Gene | Entrez_id | Symbol | Resource(Total Genes:5) |
| Text Mined Gene | Entrez_id | Symbol | Score | Resource(Total Genes:46) 2775 | GNAO1 | DISEASES 23476 | BRD4 | DISEASES 5286 | PIK3C2A | DISEASES 6531 | SLC6A3 | DISEASES 25953 | PNKD | DISEASES 2904 | GRIN2B | DISEASES 6571 | SLC18A2 | DISEASES 5617 | PRL | DISEASES 6504 | SLAMF1 | DISEASES 1128 | CHRM1 | DISEASES 3642 | INSM1 | DISEASES 3350 | HTR1A | DISEASES 3418 | IDH2 | DISEASES 2903 | GRIN2A | DISEASES 3363 | HTR7 | DISEASES 4128 | MAOA | DISEASES 1544 | CYP1A2 | DISEASES 378884 | NHLRC1 | DISEASES 4698 | NDUFA5 | DISEASES 112476 | PRRT2 | DISEASES 5294 | PIK3CG | DISEASES 6261 | RYR1 | DISEASES 4151 | MB | DISEASES 1565 | CYP2D6 | DISEASES 1312 | COMT | DISEASES 1813 | DRD2 | DISEASES 2058 | EPRS | DISEASES 4720 | NDUFS2 | DISEASES 1376 | CPT2 | DISEASES 4958 | OMD | DISEASES 3397 | ID1 | DISEASES 7056 | THBD | DISEASES 5293 | PIK3CD | DISEASES 3356 | HTR2A | DISEASES 551 | AVP | DISEASES 1814 | DRD3 | DISEASES 6263 | RYR3 | DISEASES 2643 | GCH1 | DISEASES 64223 | MLST8 | DISEASES 4988 | OPRM1 | DISEASES 3712 | IVD | DISEASES 3347 | HTN3 | DISEASES 246744 | STH | DISEASES 102723508 | KANTR | DISEASES 104564225 | MHRT | DISEASES 4566 | MT-TK | DISEASES |
| Locus | (Waiting for update.) |
| Disease ID | 273 |
|---|---|
| Disease | neuroleptic malignant syndrome |
| Integrated Phenotype | (Waiting for update.) |
| Text Mined Phenotype | HPO | Name | Sentences' Count(Total Phenotypes:13) HP:0001945 | Fever | 3 HP:0001259 | Coma | 2 HP:0002047 | Malignant hyperthermia | 1 HP:0001907 | Thromboembolic disease | 1 HP:0003201 | Rhabdomyolysis | 1 HP:0001249 | Mental retardation | 1 HP:0007302 | Bipolar disorder | 1 HP:0000716 | Depression | 1 HP:0008942 | Rhabdomyolysis, acute | 1 HP:0001649 | Tachycardia | 1 HP:0002383 | Encephalitis | 1 HP:0002185 | Paired helical filaments | 1 HP:0000726 | Dementia | 1 |
| Disease ID | 273 |
|---|---|
| Disease | neuroleptic malignant syndrome |
| Manually Symptom | UMLS | Name(Total Manually Symptoms:11) C0752335 | neuropsychiatric systemic lupus erythematosus C0262404 | cerebellar degeneration C0241831 | cerebral salt-wasting syndrome C0162557 | fulminant liver failure C0040034 | thrombocytopenia C0038868 | progressive supranuclear palsy C0038454 | cerebral infarction C0022660 | acute renal failure C0020625 | hyponatremia C0018801 | cardiac failure C0007459 | neurogenic bladder |
| Text Mined Symptom | (Waiting for update.) |
Manually Genotype(Total Text Mining Genotypes:0) |
|---|
| (Waiting for update.) |
All Snps(Total Genotypes:1) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| snpId | pubmedId | geneId | geneSymbol | diseaseId | sourceId | sentence | score | Year | geneSymbol_dbSNP | CHROMOSOME | POS | REF | ALT |
| rs1801028 | 15094790 | 1813 | DRD2 | umls:C0027849 | BeFree | We therefore investigated the association between NMS and three functional polymorphisms of the dopamine D(2) receptor (DRD(2)) gene: TaqI A, -141C Ins/Del, and Ser311Cys. | 0.01444989 | 2004 | DRD2 | 11 | 113412762 | G | C |
GWASdb Annotation(Total Genotypes:0) | |
|---|---|
| (Waiting for update.) | |
GWASdb Snp Trait(Total Genotypes:0) | |
|---|---|
| (Waiting for update.) | |
Mapped by lexical matching(Total Items:0) |
|---|
| (Waiting for update.) |
Mapped by homologous gene(Total Items:0) |
|---|
| (Waiting for update.) |
Chemical(Total Drugs:23) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0027849 | acetaminophen | D000082 | 103-90-2 | neuroleptic malignant syndrome | MESH:D009459 | therapeutic | 1590507 | ||
| C0027849 | alprazolam | D000525 | 28981-97-7 | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 16720068 | ||
| C0027849 | amoxapine | D000657 | 14028-44-5 | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 10710250 | ||
| C0027849 | amphetamine | D000661 | 300-62-9 | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 8801378 | ||
| C0027849 | aripiprazole | D000068180 | - | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 17272970 | ||
| C0027849 | baclofen | D001418 | 1134-47-0 | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 11277611 | ||
| C0027849 | carbamazepine | D002220 | 298-46-4 | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 1948228 | ||
| C0027849 | chlorpromazine | D002746 | 50-53-3 | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 1485575 | ||
| C0027849 | clozapine | D003024 | 5786-21-0 | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 10085753 | ||
| C0027849 | droperidol | D004329 | 548-73-2 | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 11406684 | ||
| C0027849 | fluvoxamine | D016666 | 54739-18-3 | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 15800166 | ||
| C0027849 | haloperidol | D006220 | 52-86-8 | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 10628507 | ||
| C0027849 | lorazepam | D008140 | 846-49-1 | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 11282706 | ||
| C0027849 | lorazepam | D008140 | 846-49-1 | neuroleptic malignant syndrome | MESH:D009459 | therapeutic | 15362259 | ||
| C0027849 | loxapine | D008152 | 1977/10/2 | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 6822486 | ||
| C0027849 | methylphenidate | D008774 | 113-45-1 | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 9831002 | ||
| C0027849 | olanzapine | C076029 | 132539-06-1 | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 10085753 | ||
| C0027849 | olanzapine | C076029 | 132539-06-1 | neuroleptic malignant syndrome | MESH:D009459 | therapeutic | 11074330 | ||
| C0027849 | phenytoin | D010672 | 57-41-0 | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 17156702 | ||
| C0027849 | procyclidine | D011352 | 77-37-2 | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 6407647 | ||
| C0027849 | propranolol | D011433 | 525-66-6 | neuroleptic malignant syndrome | MESH:D009459 | therapeutic | 10628507 | ||
| C0027849 | tetrabenazine | D013747 | 58-46-8 | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 24881749 | ||
| C0027849 | ziprasidone | C092292 | 146939-27-7 | neuroleptic malignant syndrome | MESH:D009459 | marker/mechanism | 16352776 | ||
FDA approved drug and dosage information(Total Drugs:31) | ||||||||
|---|---|---|---|---|---|---|---|---|
| DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
| MESH:D009459 | daytrana | methylphenidate | 10MG/9HR (1.1MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | No |
| MESH:D009459 | daytrana | methylphenidate | 10MG/9HR (1.1MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | No |
| MESH:D009459 | daytrana | methylphenidate | 10MG/9HR (1.1MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | No |
| MESH:D009459 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D009459 | abilify | aripiprazole | 1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | SOLUTION;ORAL | Discontinued | None | Yes | No |
| MESH:D009459 | abilify | aripiprazole | 10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
| MESH:D009459 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D009459 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D009459 | abilify | aripiprazole | 1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | SOLUTION;ORAL | Discontinued | None | Yes | No |
| MESH:D009459 | abilify | aripiprazole | 10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
| MESH:D009459 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D009459 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D009459 | abilify | aripiprazole | 1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | SOLUTION;ORAL | Discontinued | None | Yes | No |
| MESH:D009459 | abilify | aripiprazole | 10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
| MESH:D009459 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D009459 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D009459 | abilify | aripiprazole | 1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | SOLUTION;ORAL | Discontinued | None | Yes | No |
| MESH:D009459 | abilify | aripiprazole | 10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
| MESH:D009459 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D009459 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D009459 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D009459 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D009459 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D009459 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D009459 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D009459 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D009459 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D009459 | ofirmev | acetaminophen | 1GM/100ML (10MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | Yes |
| MESH:D009459 | ofirmev | acetaminophen | 1GM/100ML (10MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | Yes |
| MESH:D009459 | acetaminophen | acetaminophen | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | None | Yes | Yes |
| MESH:D009459 | acetaminophen | acetaminophen | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | None | Yes | Yes |
FDA labeling changes(Total Drugs:31) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DiseaseID | Pediatric_Labeling_Date | Trade_Name | Generic_Name_or_Proper_Name | Indications Studied | Label Changes Summary | Product Labeling | BPCA(B) | PREA(P) | BPCA(B) and PREA(P) | Pediatric Rule (R) | Sponsor | Pediatric Exclusivity Granted Date | NNPS |
| MESH:D009459 | 6/4/2006 | daytrana | methylphenidate | ADHD | Summary is pending | Labeling | - | P | - | - | Shire | - | FALSE' |
| MESH:D009459 | 12/14/2009 | daytrana | methylphenidate | Postmarketing safety study | Information added to Warnings and Adverse Reactions on skin reactions observed in a postmarketing dermal study in pediatric patients | Labeling | - | P | - | - | Shire | - | FALSE' |
| MESH:D009459 | 06/29/2010 | daytrana | methylphenidate | ADHD | Expanded pediatric indication to include adolescent patients ages13-17 years The most commonly reported adverse reactions in a trial in patients 13-17 years included appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia. The majority of patients had erythema at the application site Information on PK parameters, Adverse Event profile and clinical studies | Labeling | - | P | - | - | Shire | - | FALSE' |
| MESH:D009459 | 10/29/2007 | abilify | aripiprazole | Schizophrenia | Extended schizophrenia indication from adults to adolescents 1317 years Safety and effectiveness in pediatric patients with bipolar mania or agitation associated with schizophrenia or bipolar mania have not been established Efficacy for the maintenance treatment of schizophrenia in the pediatric population has not been evaluated In 6-week placebo controlled efficacy trial in patients 13 17 years with Schizophrenia 30 mg/day was not shown to be more efficacious than 10 mg/day Common adverse events observed were extrapyramidal disorder, somnolence, and tremor; these 3 AEs appear to have a possible dose response relationship Information on dose, AEs, clinical studies | Labeling | B | - | - | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D009459 | 10/29/2007 | abilify | aripiprazole | Schizophrenia | Extended schizophrenia indication from adults to adolescents 1317 years Safety and effectiveness in pediatric patients with bipolar mania or agitation associated with schizophrenia or bipolar mania have not been established Efficacy for the maintenance treatment of schizophrenia in the pediatric population has not been evaluated In 6-week placebo controlled efficacy trial in patients 13 17 years with Schizophrenia 30 mg/day was not shown to be more efficacious than 10 mg/day Common adverse events observed were extrapyramidal disorder, somnolence, and tremor; these 3 AEs appear to have a possible dose response relationship Information on dose, AEs, clinical studies | Labeling | B | - | - | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D009459 | 10/29/2007 | abilify | aripiprazole | Schizophrenia | Extended schizophrenia indication from adults to adolescents 1317 years Safety and effectiveness in pediatric patients with bipolar mania or agitation associated with schizophrenia or bipolar mania have not been established Efficacy for the maintenance treatment of schizophrenia in the pediatric population has not been evaluated In 6-week placebo controlled efficacy trial in patients 13 17 years with Schizophrenia 30 mg/day was not shown to be more efficacious than 10 mg/day Common adverse events observed were extrapyramidal disorder, somnolence, and tremor; these 3 AEs appear to have a possible dose response relationship Information on dose, AEs, clinical studies | Labeling | B | - | - | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D009459 | 10/29/2007 | abilify | aripiprazole | Schizophrenia | Extended schizophrenia indication from adults to adolescents 1317 years Safety and effectiveness in pediatric patients with bipolar mania or agitation associated with schizophrenia or bipolar mania have not been established Efficacy for the maintenance treatment of schizophrenia in the pediatric population has not been evaluated In 6-week placebo controlled efficacy trial in patients 13 17 years with Schizophrenia 30 mg/day was not shown to be more efficacious than 10 mg/day Common adverse events observed were extrapyramidal disorder, somnolence, and tremor; these 3 AEs appear to have a possible dose response relationship Information on dose, AEs, clinical studies | Labeling | B | - | - | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D009459 | 02/27/2008 | abilify | aripiprazole | Bipolar I Disorder | Extended treatment of acute Bipolar Disorder indication from adults to pediatrics 1017 years The efficacy for the maintenance treatment of Bipolar Disorder in the pediatric population has not been evaluated The recommended target dose in Bipolar Disorder is 10 mg/day. In the study of pediatric patients 10 17 years with Bipolar Mania, 4 common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder, somnolence, akathisia and salivary hypersecretion Information on dose, AEs, clinical studies | Labeling | - | - | B, P | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D009459 | 02/27/2008 | abilify | aripiprazole | Bipolar I Disorder | Extended treatment of acute Bipolar Disorder indication from adults to pediatrics 1017 years The efficacy for the maintenance treatment of Bipolar Disorder in the pediatric population has not been evaluated The recommended target dose in Bipolar Disorder is 10 mg/day. In the study of pediatric patients 10 17 years with Bipolar Mania, 4 common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder, somnolence, akathisia and salivary hypersecretion Information on dose, AEs, clinical studies | Labeling | - | - | B, P | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D009459 | 02/27/2008 | abilify | aripiprazole | Bipolar I Disorder | Extended treatment of acute Bipolar Disorder indication from adults to pediatrics 1017 years The efficacy for the maintenance treatment of Bipolar Disorder in the pediatric population has not been evaluated The recommended target dose in Bipolar Disorder is 10 mg/day. In the study of pediatric patients 10 17 years with Bipolar Mania, 4 common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder, somnolence, akathisia and salivary hypersecretion Information on dose, AEs, clinical studies | Labeling | - | - | B, P | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D009459 | 02/27/2008 | abilify | aripiprazole | Bipolar I Disorder | Extended treatment of acute Bipolar Disorder indication from adults to pediatrics 1017 years The efficacy for the maintenance treatment of Bipolar Disorder in the pediatric population has not been evaluated The recommended target dose in Bipolar Disorder is 10 mg/day. In the study of pediatric patients 10 17 years with Bipolar Mania, 4 common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder, somnolence, akathisia and salivary hypersecretion Information on dose, AEs, clinical studies | Labeling | - | - | B, P | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D009459 | 11/19/2009 | abilify | aripiprazole | Irritability associated with autistic disorder | Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two placebo-controlled clinical trials in pediatric patients 6 - 17 years of age Most common adverse reactions observed in pediatric clinical trials in patients with autistic disorder included sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy. Fatigue was a possible dose-response adverse reaction. Information on dosing, adverse reactions, and clinical studies | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D009459 | 11/19/2009 | abilify | aripiprazole | Irritability associated with autistic disorder | Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two placebo-controlled clinical trials in pediatric patients 6 - 17 years of age Most common adverse reactions observed in pediatric clinical trials in patients with autistic disorder included sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy. Fatigue was a possible dose-response adverse reaction. Information on dosing, adverse reactions, and clinical studies | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D009459 | 11/19/2009 | abilify | aripiprazole | Irritability associated with autistic disorder | Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two placebo-controlled clinical trials in pediatric patients 6 - 17 years of age Most common adverse reactions observed in pediatric clinical trials in patients with autistic disorder included sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy. Fatigue was a possible dose-response adverse reaction. Information on dosing, adverse reactions, and clinical studies | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D009459 | 11/19/2009 | abilify | aripiprazole | Irritability associated with autistic disorder | Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two placebo-controlled clinical trials in pediatric patients 6 - 17 years of age Most common adverse reactions observed in pediatric clinical trials in patients with autistic disorder included sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy. Fatigue was a possible dose-response adverse reaction. Information on dosing, adverse reactions, and clinical studies | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D009459 | 9/6/2014 | abilify | aripiprazole | Maintenance treatment of irritability associated with autistic disorder | Efficacy for the maintenance treatment of irritability associated with autistic disorder was not established in a 12 week clinical trial in 85 pediatric patients 6-17 years Information on clinical trialPostmarketing study | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D009459 | 9/6/2014 | abilify | aripiprazole | Maintenance treatment of irritability associated with autistic disorder | Efficacy for the maintenance treatment of irritability associated with autistic disorder was not established in a 12 week clinical trial in 85 pediatric patients 6-17 years Information on clinical trialPostmarketing study | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D009459 | 9/6/2014 | abilify | aripiprazole | Maintenance treatment of irritability associated with autistic disorder | Efficacy for the maintenance treatment of irritability associated with autistic disorder was not established in a 12 week clinical trial in 85 pediatric patients 6-17 years Information on clinical trialPostmarketing study | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D009459 | 9/6/2014 | abilify | aripiprazole | Maintenance treatment of irritability associated with autistic disorder | Efficacy for the maintenance treatment of irritability associated with autistic disorder was not established in a 12 week clinical trial in 85 pediatric patients 6-17 years Information on clinical trialPostmarketing study | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D009459 | 08/14/2008 | zyprexa | olanzapine | schizophrenia; bipolar disorder | Safety and effectiveness have not been established for patients less than 18 years of age In an analysis of placebo-controlled olanzapine monotherapy studies of adolescent patients, including those with schizophrenia or bipolar disorder, olanzapine was associated with: oHyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo oHyperlipidemia statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol oWeight gain olanzapine treated patients gained an average of 4.6 kg, compared to an average of 0.3 kg in placebo-treated patients with a median exposure of 3 weeks; Average weight gain during long-term therapy was 7.4 kg | - | B | - | - | - | Lilly | 10/1/2007 | FALSE' |
| MESH:D009459 | 08/14/2008 | zyprexa | olanzapine | schizophrenia; bipolar disorder | Safety and effectiveness have not been established for patients less than 18 years of age In an analysis of placebo-controlled olanzapine monotherapy studies of adolescent patients, including those with schizophrenia or bipolar disorder, olanzapine was associated with: oHyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo oHyperlipidemia statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol oWeight gain olanzapine treated patients gained an average of 4.6 kg, compared to an average of 0.3 kg in placebo-treated patients with a median exposure of 3 weeks; Average weight gain during long-term therapy was 7.4 kg | - | B | - | - | - | Lilly | 10/1/2007 | FALSE' |
| MESH:D009459 | 08/14/2008 | zyprexa | olanzapine | schizophrenia; bipolar disorder | Safety and effectiveness have not been established for patients less than 18 years of age In an analysis of placebo-controlled olanzapine monotherapy studies of adolescent patients, including those with schizophrenia or bipolar disorder, olanzapine was associated with: oHyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo oHyperlipidemia statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol oWeight gain olanzapine treated patients gained an average of 4.6 kg, compared to an average of 0.3 kg in placebo-treated patients with a median exposure of 3 weeks; Average weight gain during long-term therapy was 7.4 kg | - | B | - | - | - | Lilly | 10/1/2007 | FALSE' |
| MESH:D009459 | 08/14/2008 | zyprexa | olanzapine | schizophrenia; bipolar disorder | Safety and effectiveness have not been established for patients less than 18 years of age In an analysis of placebo-controlled olanzapine monotherapy studies of adolescent patients, including those with schizophrenia or bipolar disorder, olanzapine was associated with: oHyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo oHyperlipidemia statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol oWeight gain olanzapine treated patients gained an average of 4.6 kg, compared to an average of 0.3 kg in placebo-treated patients with a median exposure of 3 weeks; Average weight gain during long-term therapy was 7.4 kg | - | B | - | - | - | Lilly | 10/1/2007 | FALSE' |
| MESH:D009459 | 4/12/2009 | zyprexa | olanzapine | Treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17 | Extended schizophrenia and manic or mixed episodes of bipolar I disorder indications from adults to adolescents 1317 years of age Safety and effectiveness in children < 13 years of age have not been established Recommended starting dose for adolescents is lower than that for adults Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels Information on dosing, adverse reactions, pharmacokinetics, clinical studies | Labeling | B | - | - | - | Lilly | 10/1/2007 | TRUE' |
| MESH:D009459 | 4/12/2009 | zyprexa | olanzapine | Treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17 | Extended schizophrenia and manic or mixed episodes of bipolar I disorder indications from adults to adolescents 1317 years of age Safety and effectiveness in children < 13 years of age have not been established Recommended starting dose for adolescents is lower than that for adults Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels Information on dosing, adverse reactions, pharmacokinetics, clinical studies | Labeling | B | - | - | - | Lilly | 10/1/2007 | TRUE' |
| MESH:D009459 | 4/12/2009 | zyprexa | olanzapine | Treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17 | Extended schizophrenia and manic or mixed episodes of bipolar I disorder indications from adults to adolescents 1317 years of age Safety and effectiveness in children < 13 years of age have not been established Recommended starting dose for adolescents is lower than that for adults Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels Information on dosing, adverse reactions, pharmacokinetics, clinical studies | Labeling | B | - | - | - | Lilly | 10/1/2007 | TRUE' |
| MESH:D009459 | 4/12/2009 | zyprexa | olanzapine | Treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17 | Extended schizophrenia and manic or mixed episodes of bipolar I disorder indications from adults to adolescents 1317 years of age Safety and effectiveness in children < 13 years of age have not been established Recommended starting dose for adolescents is lower than that for adults Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels Information on dosing, adverse reactions, pharmacokinetics, clinical studies | Labeling | B | - | - | - | Lilly | 10/1/2007 | TRUE' |
| MESH:D009459 | 2/11/2010 | ofirmev | acetaminophen | Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever | The safety and effectiveness of Ofirmev for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Ofirmev in adults. Additional safety and PK data was collected in 355 from premature neonates to adolescents. The effectiveness of Ofirmev for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.The PK exposure of Ofirmev observed in children and adolescents is similar to adults, but higher in neonates and infants. Dosing simulations from PK data in infants and neonates suggest that dose reductions of 33% in infants 1 month to < 2 years of age, and 50% in neonates up to 28 days, with a minimum dosing interval of 6 hours, will produce a PK exposure similar to that observed in children age 2 years and olderMost common adverse reactions in pediatric patients were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.Information on dosing, clinical studies, adverse reactions and PK parametersNew dosage form and route of administration | Labeling | - | P | - | - | Cadence | - | FALSE' |
| MESH:D009459 | 01/27/2017 | ofirmev | acetaminophen | Treatmeny of pain and fever in pediatric patients birth to 2 years | Treatment of pain Efficacy was not demonstrated in pediatric patients younger than 2 years in a double-blind, placebo-controlled study of 198 pediatric patients younger than 2 years. Pediatric patients less than 2 years of age, including neonates from 28 to 40 weeks gestational age at birth, were randomized to receive opioid plus acetaminophen or opioid plus placebo. No difference in analgesic effect of intravenous acetaminophen, measured by assessment of reduced need for additional opioid treatment for pain control, was observed. Treatment of fever The safety and effectiveness for the treatment of fever in pediatric patients, including premature neonates born at 32 weeks or greater gestation is supported by adequate and well-controlled studies of Ofirmev in adults, clinical studies in 244 pediatric patients 2 years and older, and safety and pharmacokinetic data from 239 patients younger than 2 years including neonates 32 weeks or greater gestational age. Information on dosing, clinical trials. Postmarketing study. | Labeling | - | - | B,P | - | Mallinckrodt | 11/7/2016 | FALSE |
| MESH:D009459 | 2/11/2010 | ofirmev | acetaminophen | Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever | The safety and effectiveness of Ofirmev for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Ofirmev in adults. Additional safety and PK data was collected in 355 from premature neonates to adolescents. The effectiveness of Ofirmev for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.The PK exposure of Ofirmev observed in children and adolescents is similar to adults, but higher in neonates and infants. Dosing simulations from PK data in infants and neonates suggest that dose reductions of 33% in infants 1 month to < 2 years of age, and 50% in neonates up to 28 days, with a minimum dosing interval of 6 hours, will produce a PK exposure similar to that observed in children age 2 years and olderMost common adverse reactions in pediatric patients were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.Information on dosing, clinical studies, adverse reactions and PK parametersNew dosage form and route of administration | Labeling | - | P | - | - | Cadence | - | FALSE' |
| MESH:D009459 | 01/27/2017 | ofirmev | acetaminophen | Treatmeny of pain and fever in pediatric patients birth to 2 years | Treatment of pain Efficacy was not demonstrated in pediatric patients younger than 2 years in a double-blind, placebo-controlled study of 198 pediatric patients younger than 2 years. Pediatric patients less than 2 years of age, including neonates from 28 to 40 weeks gestational age at birth, were randomized to receive opioid plus acetaminophen or opioid plus placebo. No difference in analgesic effect of intravenous acetaminophen, measured by assessment of reduced need for additional opioid treatment for pain control, was observed. Treatment of fever The safety and effectiveness for the treatment of fever in pediatric patients, including premature neonates born at 32 weeks or greater gestation is supported by adequate and well-controlled studies of Ofirmev in adults, clinical studies in 244 pediatric patients 2 years and older, and safety and pharmacokinetic data from 239 patients younger than 2 years including neonates 32 weeks or greater gestational age. Information on dosing, clinical trials. Postmarketing study. | Labeling | - | - | B,P | - | Mallinckrodt | 11/7/2016 | FALSE |