PedAM
Pediatric Disease Annotations & Medicines
| huntington disease | ||||
| Disease ID | 3 |
|---|---|
| Disease | huntington disease |
| Integrated Phenotype | HPO | Name(Total Integrated Phenotypes:8) HP:0000726 | Dementia HP:0002376 | Developmental regression HP:0100022 | Abnormality of movement HP:0002120 | Cerebral cortical atrophy HP:0000708 | Behavioral abnormality HP:0001608 | Abnormality of the voice HP:0002353 | EEG abnormality HP:0001257 | Spasticity |
| Text Mined Phenotype | HPO | Name | Sentences' Count(Total Phenotypes:12) HP:0002072 | Chorea | 5 HP:0000716 | Depression | 2 HP:0002354 | Memory loss | 1 HP:0000713 | Agitation | 1 HP:0100543 | Cognitive deficits | 1 HP:0002180 | Neurodegeneration | 1 HP:0040140 | Degeneration of the striatum | 1 HP:0100022 | Movement disorder | 1 HP:0001297 | Cerebral vascular events | 1 HP:0100033 | Tic disorder | 1 HP:0001268 | Mental deterioration | 1 HP:0100512 | Vitamin D deficiency | 1 |
| Disease ID | 3 |
|---|---|
| Disease | huntington disease |
| Manually Symptom | UMLS | Name(Total Manually Symptoms:18) C2364072 | depression C0851578 | sleep disturbances C0686347 | tardive dyskinesia C0575081 | gait abnormalities C0525041 | cognitive symptoms C0525041 | cognitive manifestations C0497327 | dementia C0427086 | involuntary movements C0426980 | motor symptoms C0240805 | prodrome C0235946 | brain atrophy C0235031 | neurological symptoms C0233401 | psychiatric symptoms C0028768 | obsessive compulsive disorder C0026650 | movement disorder C0023015 | language disorders C0011849 | diabetes mellitus C0008489 | chorea |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:6) C0008489 | chorea | 3 C0426980 | motor symptoms | 2 C0011570 | depression | 2 C0233401 | psychiatric symptoms | 2 C0026650 | movement disorder | 1 C0235031 | neurological symptoms | 1 |
Manually Genotype(Total Text Mining Genotypes:0) |
|---|
| (Waiting for update.) |
All Snps(Total Genotypes:26) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| snpId | pubmedId | geneId | geneSymbol | diseaseId | sourceId | sentence | score | Year | geneSymbol_dbSNP | CHROMOSOME | POS | REF | ALT |
| rs1042522 | 16202123 | 7157 | TP53 | umls:C0020179 | BeFree | Age at onset of Huntington disease is not modulated by the R72P variation in TP53 and the R196K variation in the gene coding for the human caspase activated DNase (hCAD). | 0.003538676 | 2005 | TP53 | 17 | 7676154 | G | T,C |
| rs1052133 | 19857538 | 4968 | OGG1 | umls:C0020179 | BeFree | In the present study, performed on blood DNA from 91 HD subjects, we observed that bearers of the mutant Cys326 allele (Ser326Cys+Cys326Cys) tend to have an increased number of CAG repeats of the expanded HD allele (P=0.049); moreover bearers of at least one copy of the mutant Cys326 allele, mainly heterozygous subjects, showed a significant (P=0.041) earlier disease onset than Ser326Ser wild-type individuals, suggesting a possible role of the hOGG1 Ser326Cys polymorphism in HD phenotype. | 0.123181358 | 2010 | OGG1;CAMK1 | 3 | 9757089 | C | G |
| rs11540654 | 16202123 | 7157 | TP53 | umls:C0020179 | BeFree | Age at onset of Huntington disease is not modulated by the R72P variation in TP53 and the R196K variation in the gene coding for the human caspase activated DNase (hCAD). | 0.003538676 | 2005 | TP53 | 17 | 7676040 | C | T,G,A |
| rs1207568 | 19119257 | 9365 | KL | umls:C0020179 | BeFree | We investigated the relationship between the klotho G-395A polymorphism and early dysfunction in vascular access in HD patients. | 0.000542884 | 2008 | KL;LOC101927403 | 13 | 33016046 | G | A |
| rs1207568 | 19690404 | 9365 | KL | umls:C0020179 | BeFree | KLOTHO gene SNPs G-395A and C1818T are associated with low-density lipoprotein cholesterol and uric acid in HD patients. | 0.000542884 | 2009 | KL;LOC101927403 | 13 | 33016046 | G | A |
| rs1801131 | 16372906 | 4524 | MTHFR | umls:C0020179 | BeFree | Recently, suggestive association has been reported between a single nucleotide polymorphism (SNP; rs1801131, also known as A1298C) in the methyltetrahydrofolate reductase (MTHFR) gene and AO of HD. | 0.00827274 | 2005 | MTHFR | 1 | 11794419 | T | G |
| rs1805015 | 23462527 | 3596 | IL13 | umls:C0020179 | BeFree | We searched for an association between the interleukin 4 receptor gene (IL4R) rs1805015 and interleukin 13 gene (IL13) rs20541 polymorphisms and the development of antibodies to hepatitis B surface antigen (anti-HBs) in the case of hepatitis B virus (HBV) vaccination or infection in hemodialysis (HD) patients. | 0.000542884 | 2013 | IL4R | 16 | 27362859 | T | C |
| rs1805015 | 23462527 | 3566 | IL4R | umls:C0020179 | BeFree | We searched for an association between the interleukin 4 receptor gene (IL4R) rs1805015 and interleukin 13 gene (IL13) rs20541 polymorphisms and the development of antibodies to hepatitis B surface antigen (anti-HBs) in the case of hepatitis B virus (HBV) vaccination or infection in hemodialysis (HD) patients. | 0.000271442 | 2013 | IL4R | 16 | 27362859 | T | C |
| rs193922950 | NA | 3064 | HTT | umls:C0020179 | CLINVAR | NA | 0.703824291 | NA | NA | NA | NA | NA | NA |
| rs193922951 | NA | 3064 | HTT | umls:C0020179 | CLINVAR | NA | 0.703824291 | NA | NA | NA | NA | NA | NA |
| rs20541 | 23462527 | 3566 | IL4R | umls:C0020179 | BeFree | We searched for an association between the interleukin 4 receptor gene (IL4R) rs1805015 and interleukin 13 gene (IL13) rs20541 polymorphisms and the development of antibodies to hepatitis B surface antigen (anti-HBs) in the case of hepatitis B virus (HBV) vaccination or infection in hemodialysis (HD) patients. | 0.000271442 | 2013 | IL13 | 5 | 132660272 | A | G |
| rs20541 | 23462527 | 3596 | IL13 | umls:C0020179 | BeFree | We searched for an association between the interleukin 4 receptor gene (IL4R) rs1805015 and interleukin 13 gene (IL13) rs20541 polymorphisms and the development of antibodies to hepatitis B surface antigen (anti-HBs) in the case of hepatitis B virus (HBV) vaccination or infection in hemodialysis (HD) patients. | 0.000542884 | 2013 | IL13 | 5 | 132660272 | A | G |
| rs2273773 | 22200427 | 23411 | SIRT1 | umls:C0020179 | BeFree | This study aimed to investigate the association of SIRT 1 gene single-nucleotide polymorphisms, namely, rs7895833, rs7069102, and rs2273773 with lipid profiles and coronary artery calcification score in 219 Japanese hemodialysis (HD) patients. | 0.000542884 | 2012 | SIRT1 | 10 | 67906841 | T | C |
| rs35652124 | 24904228 | 4780 | NFE2L2 | umls:C0020179 | BeFree | This study aimed to investigate the association of Nrf2 gene single nucleotide polymorphisms (SNPs), rs35652124 (-653A/G) and rs6721961 (-617C/A), with laboratory data and mortality in hemodialysis (HD) patients. | 0.080542884 | 2014 | NFE2L2 | 2 | 177265345 | T | C |
| rs386572987 | 20185929 | 2739 | GLO1 | umls:C0020179 | BeFree | The A419C (E111A) polymorphism of the GLO I gene is associated with vascular disease in hemodialysis (HD) patients and some RAGE gene polymorphisms are implicated in various pathological states. | 0.000542884 | 2010 | NA | NA | NA | NA | NA |
| rs386572987 | 20185929 | 177 | AGER | umls:C0020179 | BeFree | The A419C (E111A) polymorphism of the GLO I gene is associated with vascular disease in hemodialysis (HD) patients and some RAGE gene polymorphisms are implicated in various pathological states. | 0.000542884 | 2010 | NA | NA | NA | NA | NA |
| rs386572987 | 20185929 | 5891 | MOK | umls:C0020179 | BeFree | The A419C (E111A) polymorphism of the GLO I gene is associated with vascular disease in hemodialysis (HD) patients and some RAGE gene polymorphisms are implicated in various pathological states. | 0.000542884 | 2010 | NA | NA | NA | NA | NA |
| rs386572987 | 20185929 | 101669765 | LINC00914 | umls:C0020179 | BeFree | The A419C (E111A) polymorphism of the GLO I gene is associated with vascular disease in hemodialysis (HD) patients and some RAGE gene polymorphisms are implicated in various pathological states. | 0.000542884 | 2010 | NA | NA | NA | NA | NA |
| rs397507444 | 16372906 | 4524 | MTHFR | umls:C0020179 | BeFree | Recently, suggestive association has been reported between a single nucleotide polymorphism (SNP; rs1801131, also known as A1298C) in the methyltetrahydrofolate reductase (MTHFR) gene and AO of HD. | 0.00827274 | 2005 | MTHFR | 1 | 11794407 | T | G |
| rs4746 | 20185929 | 5891 | MOK | umls:C0020179 | BeFree | The A419C (E111A) polymorphism of the GLO I gene is associated with vascular disease in hemodialysis (HD) patients and some RAGE gene polymorphisms are implicated in various pathological states. | 0.000542884 | 2010 | GLO1 | 6 | 38682852 | T | G |
| rs4746 | 20185929 | 2739 | GLO1 | umls:C0020179 | BeFree | The A419C (E111A) polymorphism of the GLO I gene is associated with vascular disease in hemodialysis (HD) patients and some RAGE gene polymorphisms are implicated in various pathological states. | 0.000542884 | 2010 | GLO1 | 6 | 38682852 | T | G |
| rs4746 | 20185929 | 101669765 | LINC00914 | umls:C0020179 | BeFree | The A419C (E111A) polymorphism of the GLO I gene is associated with vascular disease in hemodialysis (HD) patients and some RAGE gene polymorphisms are implicated in various pathological states. | 0.000542884 | 2010 | GLO1 | 6 | 38682852 | T | G |
| rs4746 | 20185929 | 177 | AGER | umls:C0020179 | BeFree | The A419C (E111A) polymorphism of the GLO I gene is associated with vascular disease in hemodialysis (HD) patients and some RAGE gene polymorphisms are implicated in various pathological states. | 0.000542884 | 2010 | GLO1 | 6 | 38682852 | T | G |
| rs6721961 | 24904228 | 4780 | NFE2L2 | umls:C0020179 | BeFree | This study aimed to investigate the association of Nrf2 gene single nucleotide polymorphisms (SNPs), rs35652124 (-653A/G) and rs6721961 (-617C/A), with laboratory data and mortality in hemodialysis (HD) patients. | 0.080542884 | 2014 | NFE2L2 | 2 | 177265309 | T | C,G |
| rs7069102 | 22200427 | 23411 | SIRT1 | umls:C0020179 | BeFree | This study aimed to investigate the association of SIRT 1 gene single-nucleotide polymorphisms, namely, rs7895833, rs7069102, and rs2273773 with lipid profiles and coronary artery calcification score in 219 Japanese hemodialysis (HD) patients. | 0.000542884 | 2012 | SIRT1 | 10 | 67903362 | C | G |
| rs7895833 | 22200427 | 23411 | SIRT1 | umls:C0020179 | BeFree | This study aimed to investigate the association of SIRT 1 gene single-nucleotide polymorphisms, namely, rs7895833, rs7069102, and rs2273773 with lipid profiles and coronary artery calcification score in 219 Japanese hemodialysis (HD) patients. | 0.000542884 | 2012 | NA | 10 | 67863299 | G | A |
GWASdb Annotation(Total Genotypes:0) | |
|---|---|
| (Waiting for update.) | |
GWASdb Snp Trait(Total Genotypes:0) | |
|---|---|
| (Waiting for update.) | |
Mapped by lexical matching(Total Items:1) | ||||
|---|---|---|---|---|
| HP ID | HP Name | MP ID | MP Name | Annotation |
| HP:0100022 | Abnormality of movement | MP:0001404 | no spontaneous movement;HP:0001608 | Abnormality of the voice |
Mapped by homologous gene(Total Items:1) | ||||
|---|---|---|---|---|
| HP ID | HP Name | MP ID | MP Name | Annotation |
| HP:0100022 | Abnormality of movement | MP:0005402 | abnormal action potential;HP:0001276 | Hypertonia |
Chemical(Total Drugs:8) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0020179 | aripiprazole | D000068180 | - | huntington disease | MESH:D006816 | therapeutic | 19170197 | ||
| C0020179 | creatine | D003401 | 57-00-1 | huntington disease | MESH:D006816 | therapeutic | 19476553 | ||
| C0020179 | dronabinol | D013759 | - | huntington disease | MESH:D006816 | therapeutic | 20929960 | ||
| C0020179 | methylphenidate | D008774 | 113-45-1 | huntington disease | MESH:D006816 | marker/mechanism | 18658080 | ||
| C0020179 | nortriptyline | D009661 | 72-69-5 | huntington disease | MESH:D006816 | therapeutic | 17686041 | ||
| C0020179 | olanzapine | C076029 | 132539-06-1 | huntington disease | MESH:D006816 | therapeutic | 10751925 | ||
| C0020179 | sirolimus | D020123 | 53123-88-9 | huntington disease | MESH:D006816 | therapeutic | 17921520 | ||
| C0020179 | tetrabenazine | D013747 | 58-46-8 | huntington disease | MESH:D006816 | therapeutic | 132600 | ||
FDA approved drug and dosage information(Total Drugs:25) | ||||||||
|---|---|---|---|---|---|---|---|---|
| DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
| MESH:D006816 | rapamune | sirolimus | 1MG/ML | SOLUTION;ORAL | Prescription | None | Yes | Yes |
| MESH:D006816 | rapamune | sirolimus | 1MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D006816 | daytrana | methylphenidate | 10MG/9HR (1.1MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | No |
| MESH:D006816 | daytrana | methylphenidate | 10MG/9HR (1.1MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | No |
| MESH:D006816 | daytrana | methylphenidate | 10MG/9HR (1.1MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | No |
| MESH:D006816 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D006816 | 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:D006816 | 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:D006816 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D006816 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D006816 | 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:D006816 | 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:D006816 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D006816 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D006816 | 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:D006816 | 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:D006816 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D006816 | abilify | aripiprazole | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D006816 | 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:D006816 | 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:D006816 | abilify | aripiprazole | 9.75MG/1.3ML (7.5MG/ML) | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| MESH:D006816 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D006816 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D006816 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D006816 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
FDA labeling changes(Total Drugs:25) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:D006816 | 11/3/2005 | rapamune | sirolimus | Prophylaxis of organ rejection in patients undergoing renal transplants | Safety and efficacy established in children 13 years or older judged to be at low to moderate immunologic risk Safety was assessed in a controlled clinical trial in pediatric ( | Labeling | B | - | - | - | Wyeth | 11/17/2004 | FALSE' |
| MESH:D006816 | 11/3/2005 | rapamune | sirolimus | Prophylaxis of organ rejection in patients undergoing renal transplants | Safety and efficacy established in children 13 years or older judged to be at low to moderate immunologic risk Safety was assessed in a controlled clinical trial in pediatric ( | Labeling | B | - | - | - | Wyeth | 11/17/2004 | FALSE' |
| MESH:D006816 | 6/4/2006 | daytrana | methylphenidate | ADHD | Summary is pending | Labeling | - | P | - | - | Shire | - | FALSE' |
| MESH:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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:D006816 | 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' |