PedAM
Pediatric Disease Annotations & Medicines
| hyperprolactinemia | ||||
| Disease ID | 189 |
|---|---|
| Disease | hyperprolactinemia |
| Manually Symptom | UMLS | Name(Total Manually Symptoms:44) C2678504 | osteoporosis C2364072 | depression C2219717 | amenorrhea C2186538 | thyroid disease C2048468 | male infertility C2004489 | regurgitation C1458155 | breast tumors C1300347 | atypical polypoid adenomyoma C0877018 | pituitary gland enlargement C0877018 | pituitary enlargement C0853662 | estrogen deficiency C0700361 | distress C0678222 | mammary carcinoma C0554471 | disorder of hair growth C0554400 | galactorrhea C0553573 | primary infertility C0549622 | sexual dysfunction C0334403 | juvenile granulosa cell tumor C0278488 | metastatic breast cancer C0271737 | autoimmune addison's disease C0271623 | secondary hypogonadism C0271556 | amenorrhea-galactorrhea syndrome C0232940 | secondary amenorrhea C0232939 | primary amenorrhea C0206713 | intraductal papilloma C0206660 | germinoma C0206633 | angiomyolipoma C0154208 | ovarian dysfunction C0034013 | precocious puberty C0034012 | delayed puberty C0032460 | polycystic ovary syndrome C0032460 | polycystic ovarian disease C0032019 | pituitary tumors C0032019 | pituitary tumor C0032000 | pituitary adenomas C0032000 | pituitary adenoma C0021361 | female infertility C0021359 | infertility C0020619 | hypogonadism C0010276 | craniopharyngioma C0004364 | autoimmune disease C0003128 | anovulations C0003128 | anovulation C0001207 | acromegalic gigantism |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:11) C0002453 | amenorrhea | 6 C0020619 | hypogonadism | 5 C0235660 | galactorrhea | 5 C0021359 | infertility | 4 C0032000 | pituitary adenoma | 3 C0033953 | sexual dysfunction | 1 C0232940 | secondary amenorrhea | 1 C0271623 | secondary hypogonadism | 1 C0877018 | pituitary enlargement | 1 C0032019 | pituitary tumor | 1 C0003128 | anovulation | 1 |
Manually Genotype(Total Text Mining Genotypes:0) |
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| (Waiting for update.) |
All Snps(Total Genotypes:1) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| snpId | pubmedId | geneId | geneSymbol | diseaseId | sourceId | sentence | score | Year | geneSymbol_dbSNP | CHROMOSOME | POS | REF | ALT |
| rs398122522 | NA | 5618 | PRLR | umls:C0020514 | CLINVAR | NA | 0.360542884 | NA | PRLR | 5 | 35070174 | T | C |
GWASdb Annotation(Total Genotypes:0) | |
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| (Waiting for update.) | |
GWASdb Snp Trait(Total Genotypes:0) | |
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| (Waiting for update.) | |
Mapped by lexical matching(Total Items:0) |
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| (Waiting for update.) |
Mapped by homologous gene(Total Items:0) |
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| (Waiting for update.) |
Chemical(Total Drugs:24) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0020514 | alprazolam | D000525 | 28981-97-7 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 8803653 | ||
| C0020514 | aripiprazole | D000068180 | - | hyperprolactinemia | MESH:D006966 | marker/mechanism | 16965214 | ||
| C0020514 | aripiprazole | D000068180 | - | hyperprolactinemia | MESH:D006966 | therapeutic | 16055781 | ||
| C0020514 | cabergoline | C047047 | 81409-90-7 | hyperprolactinemia | MESH:D006966 | therapeutic | 11194712 | ||
| C0020514 | chlorpromazine | D002746 | 50-53-3 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 564936 | ||
| C0020514 | chlorpromazine | D002746 | 50-53-3 | hyperprolactinemia | MESH:D006966 | therapeutic | 718334 | ||
| C0020514 | cimetidine | D002927 | 51481-61-9 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 9037573 | ||
| C0020514 | clonidine | D003000 | 4205-90-7 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 16401171 | ||
| C0020514 | clozapine | D003024 | 5786-21-0 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 15243877 | ||
| C0020514 | cyclosporine | D016572 | 59865-13-3 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 11924803 | ||
| C0020514 | cisplatin | D002945 | 15663-27-1 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 8312290 | ||
| C0020514 | diethylstilbestrol | D004054 | 56-53-1 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 1678068 | ||
| C0020514 | fenfluramine | D005277 | 458-24-2 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 1678730 | ||
| C0020514 | fluoxetine | D005473 | 54910-89-3 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 16848655 | ||
| C0020514 | haloperidol | D006220 | 52-86-8 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 10661492 | ||
| C0020514 | labetalol | D007741 | 36894-69-6 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 7105431 | ||
| C0020514 | lisuride | D008090 | 18016-80-3 | hyperprolactinemia | MESH:D006966 | therapeutic | 386688 | ||
| C0020514 | methadone | D008691 | 76-99-3 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 21094671 | ||
| C0020514 | mifepristone | D015735 | 84371-65-3 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 2159045 | ||
| C0020514 | olanzapine | C076029 | 132539-06-1 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 16085789 | ||
| C0020514 | progesterone | D011374 | 57-83-0 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 2105248 | ||
| C0020514 | reserpine | D012110 | 50-55-5 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 6492995 | ||
| C0020514 | sulpiride | D013469 | 15676-16-1 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 18082301 | ||
| C0020514 | ziprasidone | C092292 | 146939-27-7 | hyperprolactinemia | MESH:D006966 | marker/mechanism | 15243877 | ||
FDA approved drug and dosage information(Total Drugs:36) | ||||||||
|---|---|---|---|---|---|---|---|---|
| DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
| MESH:D006966 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D006966 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D006966 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D006966 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D006966 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D006966 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D006966 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D006966 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D006966 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D006966 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D006966 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D006966 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D006966 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D006966 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D006966 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D006966 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
FDA labeling changes(Total Drugs:36) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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:D006966 | 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' |