PedAM
Pediatric Disease Annotations & Medicines
| liver failure, acute | ||||
| Disease ID | 1633 |
|---|---|
| Disease | liver failure, acute |
| Manually Symptom | (Waiting for update.) |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:14) C0085584 | encephalopathy | 29 C0019151 | hepatic encephalopathy | 22 C1527311 | brain edema | 8 C0005779 | coagulopathy | 6 C0019202 | wilson disease | 4 C0019158 | hepatitis | 4 C0948600 | organ failure | 3 C0020672 | hypothermia | 3 C0042769 | virus infection | 2 C0009450 | infection | 2 C0023907 | liver regeneration | 1 C0011847 | diabetes | 1 C0020649 | hypotension | 1 C0019270 | herniation | 1 |
Manually Genotype(Total Text Mining Genotypes:0) |
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| (Waiting for update.) |
All Snps(Total Genotypes:1) | |||||||||||||
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| snpId | pubmedId | geneId | geneSymbol | diseaseId | sourceId | sentence | score | Year | geneSymbol_dbSNP | CHROMOSOME | POS | REF | ALT |
| rs8330 | 23408116 | 54658 | UGT1A1 | umls:C0162557 | BeFree | The UDP-glucuronosyltransferase (UGT) 1A polymorphism c.2042C>G (rs8330) is associated with increased human liver acetaminophen glucuronidation, increased UGT1A exon 5a/5b splice variant mRNA ratio, and decreased risk of unintentional acetaminophen-induced acute liver failure. | 0.000271442 | 2013 | UGT1A10;UGT1A8;UGT1A7;UGT1A6;UGT1A5;UGT1A9;UGT1A4;UGT1A1;UGT1A3 | 2 | 233772999 | G | 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:49) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0162557 | acarbose | D020909 | 56180-94-0 | liver failure, acute | MESH:D017114 | marker/mechanism | 18648179 | ||
| C0162557 | acetaminophen | D000082 | 103-90-2 | liver failure, acute | MESH:D017114 | marker/mechanism | 10212046 | ||
| C0162557 | acetylcysteine | D000111 | 616-91-1 | liver failure, acute | MESH:D017114 | therapeutic | 10919033 | ||
| C0162557 | caffeine | D002110 | 1958/8/2 | liver failure, acute | MESH:D017114 | therapeutic | 22154906 | ||
| C0162557 | carbamazepine | D002220 | 298-46-4 | liver failure, acute | MESH:D017114 | marker/mechanism | 16033627 | ||
| C0162557 | celecoxib | D000068579 | - | liver failure, acute | MESH:D017114 | marker/mechanism | 19701976 | ||
| C0162557 | chlorambucil | D002699 | 305-03-3 | liver failure, acute | MESH:D017114 | marker/mechanism | 10922320 | ||
| C0162557 | chlorzoxazone | D002753 | 95-25-0 | liver failure, acute | MESH:D017114 | marker/mechanism | 17390222 | ||
| C0162557 | ciprofloxacin | D002939 | 85721-33-1 | liver failure, acute | MESH:D017114 | marker/mechanism | 12399240 | ||
| C0162557 | clozapine | D003024 | 5786-21-0 | liver failure, acute | MESH:D017114 | marker/mechanism | 10950478 | ||
| C0162557 | colchicine | D003078 | 64-86-8 | liver failure, acute | MESH:D017114 | marker/mechanism | 15088997 | ||
| C0162557 | cyclophosphamide | D003520 | 50-18-0 | liver failure, acute | MESH:D017114 | marker/mechanism | 19008178 | ||
| C0162557 | cyclosporine | D016572 | 59865-13-3 | liver failure, acute | MESH:D017114 | marker/mechanism | 11757752 | ||
| C0162557 | diclofenac | D004008 | 15307-86-5 | liver failure, acute | MESH:D017114 | marker/mechanism | 11204815 | ||
| C0162557 | doxycycline | D004318 | 564-25-0 | liver failure, acute | MESH:D017114 | marker/mechanism | 19539102 | ||
| C0162557 | enalapril | D004656 | 75847-73-3 | liver failure, acute | MESH:D017114 | marker/mechanism | 11141678 | ||
| C0162557 | entecavir | C413685 | - | liver failure, acute | MESH:D017114 | therapeutic | 21186528 | ||
| C0162557 | flutamide | D005485 | 13311-84-7 | liver failure, acute | MESH:D017114 | marker/mechanism | 10215102 | ||
| C0162557 | imatinib mesylate | D000068877 | - | liver failure, acute | MESH:D017114 | marker/mechanism | 18161937 | ||
| C0162557 | imipramine | D007099 | 50-49-7 | liver failure, acute | MESH:D017114 | marker/mechanism | 2315196 | ||
| C0162557 | lamotrigine | C047781 | 84057-84-1 | liver failure, acute | MESH:D017114 | marker/mechanism | 17923349 | ||
| C0162557 | lenalidomide | C467567 | - | liver failure, acute | MESH:D017114 | marker/mechanism | 20011646 | ||
| C0162557 | metformin | D008687 | 657-24-9 | liver failure, acute | MESH:D017114 | marker/mechanism | 12639207 | ||
| C0162557 | methotrexate | D008727 | 1959/5/2 | liver failure, acute | MESH:D017114 | marker/mechanism | 20141060 | ||
| C0162557 | methoxsalen | D008730 | 298-81-7 | liver failure, acute | MESH:D017114 | marker/mechanism | 8308218 | ||
| C0162557 | mirtazapine | C035133 | - | liver failure, acute | MESH:D017114 | marker/mechanism | 16797245 | ||
| C0162557 | modafinil | C048833 | 68693-11-8 | liver failure, acute | MESH:D017114 | marker/mechanism | 16045030 | ||
| C0162557 | nevirapine | D019829 | 129618-40-2 | liver failure, acute | MESH:D017114 | marker/mechanism | 15213559 | ||
| C0162557 | nortriptyline | D009661 | 72-69-5 | liver failure, acute | MESH:D017114 | marker/mechanism | 7884180 | ||
| C0162557 | ofloxacin | D015242 | 82419-36-1 | liver failure, acute | MESH:D017114 | marker/mechanism | 11580158 | ||
| C0162557 | omeprazole | D009853 | 73590-58-6 | liver failure, acute | MESH:D017114 | marker/mechanism | 1553942 | ||
| C0162557 | phenytoin | D010672 | 57-41-0 | liver failure, acute | MESH:D017114 | marker/mechanism | 10915174 | ||
| C0162557 | piroxicam | D010894 | 36322-90-4 | liver failure, acute | MESH:D017114 | marker/mechanism | 12185885 | ||
| C0162557 | propylthiouracil | D011441 | 51-52-5 | liver failure, acute | MESH:D017114 | marker/mechanism | 12645809 | ||
| C0162557 | epoprostenol | D011464 | 35121-78-9 | liver failure, acute | MESH:D017114 | therapeutic | 15633222 | ||
| C0162557 | pyrazinamide | D011718 | 98-96-4 | liver failure, acute | MESH:D017114 | marker/mechanism | 12006469 | ||
| C0162557 | rifampin | D012293 | 13292-46-1 | liver failure, acute | MESH:D017114 | marker/mechanism | 12006469 | ||
| C0162557 | ritonavir | D019438 | - | liver failure, acute | MESH:D017114 | marker/mechanism | 9786823 | ||
| C0162557 | rosiglitazone | C089730 | - | liver failure, acute | MESH:D017114 | marker/mechanism | 18397974 | ||
| C0162557 | sorafenib | C471405 | - | liver failure, acute | MESH:D017114 | marker/mechanism | 18796127 | ||
| C0162557 | tenofovir | D000068698 | - | liver failure, acute | MESH:D017114 | marker/mechanism | 16176639 | ||
| C0162557 | thalidomide | D013792 | 50-35-1 | liver failure, acute | MESH:D017114 | marker/mechanism | 17493431 | ||
| C0162557 | thiopental | D013874 | 76-75-5 | liver failure, acute | MESH:D017114 | marker/mechanism | 16116121 | ||
| C0162557 | tolcapone | C066340 | 134308-13-7 | liver failure, acute | MESH:D017114 | marker/mechanism | 11052337 | ||
| C0162557 | topiramate | C052342 | 97240-79-4 | liver failure, acute | MESH:D017114 | marker/mechanism | 10915174 | ||
| C0162557 | tramadol | D014147 | 27203-92-5 | liver failure, acute | MESH:D017114 | marker/mechanism | 12850423 | ||
| C0162557 | troglitazone | C057693 | 97322-87-7 | liver failure, acute | MESH:D017114 | marker/mechanism | 10685776 | ||
| C0162557 | valproic acid | D014635 | 99-66-1 | liver failure, acute | MESH:D017114 | marker/mechanism | 10403231 | ||
| C0162557 | vancomycin | D014640 | 1404-90-6 | liver failure, acute | MESH:D017114 | marker/mechanism | 19706026 | ||
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:D017114 | prilosec | omeprazole | 20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | Yes | No |
| MESH:D017114 | prilosec | omeprazole | 20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | Yes | No |
| MESH:D017114 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| MESH:D017114 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| MESH:D017114 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D017114 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D017114 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D017114 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D017114 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D017114 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D017114 | cipro | ciprofloxacin | 400MG/40ML (10MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| MESH:D017114 | cipro | ciprofloxacin | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | No |
| MESH:D017114 | remeron | mirtazapine | 15MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D017114 | norvir | ritonavir | 80MG/ML | SOLUTION;ORAL | Prescription | None | Yes | Yes |
| MESH:D017114 | norvir | ritonavir | 100MG | CAPSULE;ORAL | Discontinued | None | No | No |
| MESH:D017114 | norvir | ritonavir | 100MG | CAPSULE;ORAL | Prescription | None | Yes | Yes |
| MESH:D017114 | norvir | ritonavir | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D017114 | gleevec | imatinib mesylate | EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | CAPSULE;ORAL | Discontinued | None | Yes | No |
| MESH:D017114 | gleevec | imatinib mesylate | EQ 100MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D017114 | celebrex | celecoxib | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D017114 | celebrex | celecoxib | 100MG | CAPSULE;ORAL | Prescription | None | No | No |
| MESH:D017114 | provigil | modafinil | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D017114 | topamax | topiramate | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D017114 | topamax | topiramate | 15MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D017114 | topamax | topiramate | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D017114 | topamax | topiramate | 15MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D017114 | topamax | topiramate | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D017114 | topamax | topiramate | 15MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D017114 | topamax | topiramate | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| MESH:D017114 | topamax | topiramate | 15MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D017114 | ofirmev | acetaminophen | 1GM/100ML (10MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | Yes |
| MESH:D017114 | ofirmev | acetaminophen | 1GM/100ML (10MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | Yes |
| MESH:D017114 | acetaminophen | acetaminophen | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | None | Yes | Yes |
| MESH:D017114 | acetaminophen | acetaminophen | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | None | Yes | Yes |
| MESH:D017114 | baraclude | entecavir | 0.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D017114 | baraclude | entecavir | 0.05MG/ML | SOLUTION;ORAL | Prescription | None | 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:D017114 | 12/7/2002 | prilosec | omeprazole | Gastroesophageal reflux and erosive esophagitis | Safety and effectiveness established in pediatric patients 2-16 years of age Information on dose, PK parameters, exposure/response and AE profile | Labeling | B | - | - | - | AstraZeneca | - | FALSE' |
| MESH:D017114 | 03/20/2008 | prilosec | omeprazole | Maintenance healing of erosive esophagitis | Efficacy was extrapolated from adults and older children to 1 to 2 year olds and supported with an open-label trial Unique adverse reactions in pediatric patients included increased respiratory system adverse events and fever. Safety and effectiveness in children less than 1 year of age have not been established Dosing and administration information provided for patients 1 year and older weighing at least 5 kg. New dosage form | Labeling | - | - | B, P | - | AstraZeneca | 1/5/2001 | FALSE' |
| MESH:D017114 | 12/7/2002 | prilosec | omeprazole | Gastroesophageal reflux and erosive esophagitis | Safety and effectiveness established in pediatric patients 2-16 years of age Information on dose, PK parameters, exposure/response and AE profile | Labeling | B | - | - | - | AstraZeneca | - | FALSE' |
| MESH:D017114 | 03/20/2008 | prilosec | omeprazole | Maintenance healing of erosive esophagitis | Efficacy was extrapolated from adults and older children to 1 to 2 year olds and supported with an open-label trial Unique adverse reactions in pediatric patients included increased respiratory system adverse events and fever. Safety and effectiveness in children less than 1 year of age have not been established Dosing and administration information provided for patients 1 year and older weighing at least 5 kg. New dosage form | Labeling | - | - | B, P | - | AstraZeneca | 1/5/2001 | FALSE' |
| MESH:D017114 | 01/17/2003 | lamictal | lamotrigine | Adjunctive therapy for partial seizures | Extended indication from adults to pediatric patients e 2 years Patients aged 2 - 18 years had clearance influenced predominantly by total body weight and concurrent antiepileptic drug (AED) therapy. The oral clearance was higher, on a body weight basis, in pediatric patients than in adults Because of increased clearance in pediatrics, maintenance doses in patients weighing < 30 kg may need an increase of as much as 50% based upon clinical response Evidence shows that the inclusion of VPA in a multi-drug regimen increases the risk of serious, potentially life-threatening rash in pediatric patients Approximately 11.5% of the 1,081 pediatric patients who received the drug as adjunctive therapy in clinical trials discontinued treatment because of an AE | Labeling | B | - | - | - | GlaxoSmithKline | 02/14/2007 | FALSE' |
| MESH:D017114 | 8/5/2009 | lamictal | lamotrigine | Adjunctive treatment for partial seizures in pediatric patients 1 24 months | Safety and effectiveness as adjunctive treatment for partial seizures were not demonstrated in a small randomized, double-blind, placebo-controlled, withdrawal study in pediatric patients 1 - 24 months Immediate release tablets were associated with an increased risk for infectious adverse reactions including bronchiolitis, bronchitis, ear infection, eye infection, otitis externa, pharyngitis, urinary tract infection, and viral infection (Lamictal 37%, Placebo 5%), and respiratory adverse reactions including nasal congestion, cough, and apnea. (Lamictal 26%, Placebo 5%) | Labeling | B | - | - | - | GlaxoSmithKline | 02/14/2007 | FALSE' |
| MESH:D017114 | 05/18/2015 | lamictal | lamotrigine | Maintenance treatment of bipolar disorder | Safety and efficacy for the maintenance treatment of bipolar disorder were not established in a double-blind, placebo-controlled trial that evaluated 301 pediatric patients aged 10 to 17 Information on clinical trial and adverse reactions Postmarketing study | Labeling | - | P | - | - | GlaxoSmithKline | - | FALSE |
| MESH:D017114 | 05/29/2009 | lamictal xr | lamotrigine | Adjunctive therapy for partial onset seizures in patients e13 years of age | Extended release tablets are indicated as adjunctive therapy for partial onset seizures with or without secondary generalization in patients e13 years Safety and effectiveness of extended release tablets for any use in patients below the age of 13 have not been established Information on adverse event profile, and clinical studies New dosage form | Labeling | - | P | - | - | GlaxoSmithKline | - | FALSE' |
| MESH:D017114 | 01/29/2010 | lamictal xr | lamotrigine | Adjunctive therapy for Primary Generalized Tonic-Clonic seizures | New indication for adjunctive therapy for primary generalized tonic-clonic seizures in patients e 13 years of age Safety and effectiveness for any use in patients < 13 years have not been established Information on dosing, adverse reactions, and clinical studies | Labeling | - | P | - | - | GlaxoSmithKline | - | FALSE' |
| MESH:D017114 | 04/25/2011 | lamictal xr | lamotrigine | Monotherapy in patients 13 years of age and older with partial seizures who are receiving therapy with a single antiepileptic drug (AED) | Approved for conversion to monotherapy in patients e13 years of age with partial seizures receiving treatment with a single antiepileptic drug (AED).Safety and effectiveness have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from two or more concomitant AEDsInformation on conversion to monotherapy, adverse reactions, clinical trialNew indication | Labeling | - | P | - | - | GlaxoSmithKline | - | FALSE' |
| MESH:D017114 | 03/25/2004 | cipro | ciprofloxacin | Complicated UTI and pyelonephritis | Indicated for the treatment of complicated urinary tract infections (cUTIs) and pyelonephritis in pediatric patients 1 17 years of age Not drug of first choice due to increased adverse events compared to controls including events related to joints and/or surrounding tissues Information on PK and dose in pediatric patients 1 17 years of age The most frequent adverse events observed within 6 weeks of treatment initiation during the cUTI clinical trial were gastrointestinal 15% compared to 9% and musculoskeletal 9.3% compared to 6% in ciprofloxacin-treated compared to control-treated patients, respectively | Labeling | B | - | - | - | Bayer | 12/18/2003 | FALSE' |
| MESH:D017114 | 03/25/2004 | cipro | ciprofloxacin | Complicated UTI and pyelonephritis | Indicated for the treatment of complicated urinary tract infections (cUTIs) and pyelonephritis in pediatric patients 1 17 years of age Not drug of first choice due to increased adverse events compared to controls including events related to joints and/or surrounding tissues Information on PK and dose in pediatric patients 1 17 years of age The most frequent adverse events observed within 6 weeks of treatment initiation during the cUTI clinical trial were gastrointestinal 15% compared to 9% and musculoskeletal 9.3% compared to 6% in ciprofloxacin-treated compared to control-treated patients, respectively | Labeling | B | - | - | - | Bayer | 12/18/2003 | FALSE' |
| MESH:D017114 | 12/1/2005 | remeron | mirtazapine | Major Depressive Disorder | Safety and effectiveness in the pediatric population have not been established FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Remeron or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Remeron is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials Two placebo-controlled trials in 258 pediatric patients with MDD have been conducted with Remeron and the data were not sufficient to support a claim for use in pediatric patients | Labeling | B | - | - | - | Organon | - | FALSE' |
| MESH:D017114 | 6/10/2005 | norvir | ritonavir | Treatment of HIV-infection in combination with other antiretroviral agents | Extended age range from 2 years down to 1 month AE profile in the pediatric population was similar to that for adults Information on dose and PK parameters | Labeling | B | - | - | - | Abbott | 06/14/2005 | FALSE' |
| MESH:D017114 | 6/10/2005 | norvir | ritonavir | Treatment of HIV-infection in combination with other antiretroviral agents | Extended age range from 2 years down to 1 month AE profile in the pediatric population was similar to that for adults Information on dose and PK parameters | Labeling | B | - | - | - | Abbott | 06/14/2005 | FALSE' |
| MESH:D017114 | 6/10/2005 | norvir | ritonavir | Treatment of HIV-infection in combination with other antiretroviral agents | Extended age range from 2 years down to 1 month AE profile in the pediatric population was similar to that for adults Information on dose and PK parameters | Labeling | B | - | - | - | Abbott | 06/14/2005 | FALSE' |
| MESH:D017114 | 6/10/2005 | norvir | ritonavir | Treatment of HIV-infection in combination with other antiretroviral agents | Extended age range from 2 years down to 1 month AE profile in the pediatric population was similar to that for adults Information on dose and PK parameters | Labeling | B | - | - | - | Abbott | 06/14/2005 | FALSE' |
| MESH:D017114 | 09/27/2006 | gleevec | imatinib mesylate | Treatment of newly diagnosed pediatric patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase | Extended age range for the treatment of newly diagnosed CML down to pediatric patients There are no data in children < 2 years of age Follow-up in children with newly diagnosed Ph+ chronic phase CML is limited Information on hematologic toxicities, AE profile, clinical studies and dosing guidelines new for newly diagnosed pediatric patients | Labeling | - | - | B, P | - | Novartis | 9/6/2006 | FALSE' |
| MESH:D017114 | 09/27/2006 | gleevec | imatinib mesylate | Treatment of newly diagnosed pediatric patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase | Extended age range for the treatment of newly diagnosed CML down to pediatric patients There are no data in children < 2 years of age Follow-up in children with newly diagnosed Ph+ chronic phase CML is limited Information on hematologic toxicities, AE profile, clinical studies and dosing guidelines new for newly diagnosed pediatric patients | Labeling | - | - | B, P | - | Novartis | 9/6/2006 | FALSE' |
| MESH:D017114 | 12/15/2006 | celebrex | celecoxib | Relief of the signs and symptoms of juvenile rheumatoid arthritis (JRA) | New indication in 2 years and older Has not been studied in patients < 2 years, in patients with body weight < 10 kg, or in patients with active systemic features Celecoxib should be used only with caution in patients with systemic onset JRA due to the risk for serious adverse reactions including the risk of disseminated intravascular coagulation The long-term cardiovascular toxicity in children has not been evaluated; it is unknown if the long-term risk may be similar to that seen in adults New 50 mg capsule developed Information on adding contents of a capsule to applesauce. for patients with difficulty swallowing capsules Information on dose, clinical studies, PK parameters, AEs | Labeling | B | - | - | - | Pfizer | 08/23/2006 | FALSE' |
| MESH:D017114 | 12/15/2006 | celebrex | celecoxib | Relief of the signs and symptoms of juvenile rheumatoid arthritis (JRA) | New indication in 2 years and older Has not been studied in patients < 2 years, in patients with body weight < 10 kg, or in patients with active systemic features Celecoxib should be used only with caution in patients with systemic onset JRA due to the risk for serious adverse reactions including the risk of disseminated intravascular coagulation The long-term cardiovascular toxicity in children has not been evaluated; it is unknown if the long-term risk may be similar to that seen in adults New 50 mg capsule developed Information on adding contents of a capsule to applesauce. for patients with difficulty swallowing capsules Information on dose, clinical studies, PK parameters, AEs | Labeling | B | - | - | - | Pfizer | 08/23/2006 | FALSE' |
| MESH:D017114 | 08/17/2007 | provigil | modafinil | Narcolepsy | Modafinil is not approved for use in pediatric patients for any indication Safety and effectiveness were not demonstrated in a controlled 6-week study in 165 pediatric patients 5-17 years with narcolepsy Serious rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with the use of modafinil In the controlled and open-label clinical studies, treatment emergent adverse events of the psychiatric and nervous system included Tourettes syndrome, insomnia, hostility, increased cataplexy, increased hypnagogic hallucinations and suicidal ideation Information on safety, AEs and clinical study | Labeling | B | - | - | - | Cephalon, Inc | 03/21/2006 | FALSE' |
| MESH:D017114 | 12/22/2009 | topamax | topiramate | Migraine Prophylaxis | Safety and effectiveness for migraine prevention in pediatric patients have not been established Dose-related increased shift in serum creatinine in adolescent patients occurred in a clinical study Information added to Warnings and Precautions and Pediatric Use | Labeling | - | P | - | - | Ortho-McNeil-Janssen | - | FALSE' |
| MESH:D017114 | 12/22/2009 | topamax | topiramate | Migraine Prophylaxis | Safety and effectiveness for migraine prevention in pediatric patients have not been established Dose-related increased shift in serum creatinine in adolescent patients occurred in a clinical study Information added to Warnings and Precautions and Pediatric Use | Labeling | - | P | - | - | Ortho-McNeil-Janssen | - | FALSE' |
| MESH:D017114 | 12/22/2009 | topamax | topiramate | Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 months | Effectiveness was not demonstrated as adjunctive therapy in a randomized, double-blind trial in infants/toddlers 1 to 24 months of age with refractory partial onset seizures Trials in infants/toddlers 1 to 24 months suggested some adverse reactions/toxicities not previously observed in older pediatric patients and adults; i.e, growth/length retardation, certain clinical laboratory abnormalities, and other adverse reactions/toxicities that occurred with a greater frequency and/or greater severity than had been recognized previously from studies in older pediatric patients or adults for various indications. Information added to Warnings and Precautions and Pediatric Use | Labeling | B | - | - | - | Ortho-McNeil-Janssen | 07/24/2008 | FALSE' |
| MESH:D017114 | 12/22/2009 | topamax | topiramate | Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 months | Effectiveness was not demonstrated as adjunctive therapy in a randomized, double-blind trial in infants/toddlers 1 to 24 months of age with refractory partial onset seizures Trials in infants/toddlers 1 to 24 months suggested some adverse reactions/toxicities not previously observed in older pediatric patients and adults; i.e, growth/length retardation, certain clinical laboratory abnormalities, and other adverse reactions/toxicities that occurred with a greater frequency and/or greater severity than had been recognized previously from studies in older pediatric patients or adults for various indications. Information added to Warnings and Precautions and Pediatric Use | Labeling | B | - | - | - | Ortho-McNeil-Janssen | 07/24/2008 | FALSE' |
| MESH:D017114 | 07/15/2011 | topamax | topiramate | Monotherapy for partial onset or primary generalized tonic-clonic seizures | Expanded age range down to 2 years; previously approved for monotherapy for partial onset or primary generalized tonic-clonic seizures in patients10 years and older Information on weight based dosing in 2 to < 10 yearsPostmarketing study | Labeling | - | P | - | - | Janssen | - | FALSE' |
| MESH:D017114 | 07/15/2011 | topamax | topiramate | Monotherapy for partial onset or primary generalized tonic-clonic seizures | Expanded age range down to 2 years; previously approved for monotherapy for partial onset or primary generalized tonic-clonic seizures in patients10 years and older Information on weight based dosing in 2 to < 10 yearsPostmarketing study | Labeling | - | P | - | - | Janssen | - | FALSE' |
| MESH:D017114 | 03/28/2014 | topamax | topiramate | Prophylaxis of migraine headache | Approved for use in pediatric patients 12 years and older Safety and effectiveness in pediatric patients less than12 years have not been established for the prophylaxis treatment of migraine headache In the adolescent migraine trials (12 to 17 years), the most commonly observed adverse reactions were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain The most common cognitive adverse reaction in pooled double-blind studies in adolescent patients 12 to 17 years was difficulty with concentration/attention Markedly abnormally low serum bicarbonate values indicative of metabolic acidosis were reported in topiramate-treated adolescent migraine patients In topiramate-treated patients 12 to 17 years compared to placebo-treated patients, abnormally increased results were more frequent for creatinine, BUN, uric acid, chloride, ammonia, total protein, and platelets. Abnormally decreased results were observed with topiramate vs placebo treatment for phosphorus and bicarbonate Notable changes (increases and decreases) from baseline in systolic blood pressure, diastolic blood pressure, and pulse were observed more commonly in adolescents treated with topiramate compared to adolescents treated with placebo Information on dosing, adverse reactions, laboratory abnormalities, and clinical trials Postmarketing study | Labeling | - | P | - | - | Janssen | - | FALSE' |
| MESH:D017114 | 03/28/2014 | topamax | topiramate | Prophylaxis of migraine headache | Approved for use in pediatric patients 12 years and older Safety and effectiveness in pediatric patients less than12 years have not been established for the prophylaxis treatment of migraine headache In the adolescent migraine trials (12 to 17 years), the most commonly observed adverse reactions were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain The most common cognitive adverse reaction in pooled double-blind studies in adolescent patients 12 to 17 years was difficulty with concentration/attention Markedly abnormally low serum bicarbonate values indicative of metabolic acidosis were reported in topiramate-treated adolescent migraine patients In topiramate-treated patients 12 to 17 years compared to placebo-treated patients, abnormally increased results were more frequent for creatinine, BUN, uric acid, chloride, ammonia, total protein, and platelets. Abnormally decreased results were observed with topiramate vs placebo treatment for phosphorus and bicarbonate Notable changes (increases and decreases) from baseline in systolic blood pressure, diastolic blood pressure, and pulse were observed more commonly in adolescents treated with topiramate compared to adolescents treated with placebo Information on dosing, adverse reactions, laboratory abnormalities, and clinical trials Postmarketing study | Labeling | - | P | - | - | Janssen | - | FALSE' |
| MESH:D017114 | 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:D017114 | 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:D017114 | 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:D017114 | 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:D017114 | 03/20/2014 | baraclude | entecavir | Treatment of chronic hepatitis B virus (HBV) infection | Approved for use in pediatric patients 2 years and older Safety and effectiveness have not been established in pediatric patients less than 2 years. Use in this age group has not been evaluated because treatment of HBV in this age group is rarely required There are limited data available on the use of Baraclude in lamivudine-experienced pediatric patients Adverse reactions in clinical trials were similar to those observed in adults Information on dosing in pediatric patients 2 years and weighing at least 10 kg, adverse reactions, PK parameters and clinical trials New dosage form | Labeling | - | - | B,P | - | Bristol-Myers Squibb | - | FALSE' |
| MESH:D017114 | 03/20/2014 | baraclude | entecavir | Treatment of chronic hepatitis B virus (HBV) infection | Approved for use in pediatric patients 2 years and older Safety and effectiveness have not been established in pediatric patients less than 2 years. Use in this age group has not been evaluated because treatment of HBV in this age group is rarely required There are limited data available on the use of Baraclude in lamivudine-experienced pediatric patients Adverse reactions in clinical trials were similar to those observed in adults Information on dosing in pediatric patients 2 years and weighing at least 10 kg, adverse reactions, PK parameters and clinical trials New dosage form | Labeling | - | - | B,P | - | Bristol-Myers Squibb | - | FALSE' |