PedAM
Pediatric Disease Annotations & Medicines
| eosinophilia | ||||
| Disease ID | 361 |
|---|---|
| Disease | eosinophilia |
| Manually Symptom | UMLS | Name(Total Manually Symptoms:57) C2697391 | rheumatoid arthritis C2364118 | weakness C1963274 | vasculitis C1963178 | myelitis C1963084 | colitis C1961102 | lymphoblastic lymphoma C1961102 | acute lymphoblastic leukemia C1801950 | g syndrome C1546654 | granuloma C0947961 | atopic disorders C0796110 | w syndrome C0752303 | urological manifestations C0699791 | gastric carcinoma C0684249 | lung cancer C0520463 | chronic active hepatitis C0497156 | lymphadenopathy C0334463 | malignant fibrous histiocytoma C0264666 | endomyocardial disease C0262988 | cutaneous vasculitis C0238462 | medullary thyroid carcinoma C0235896 | pulmonary infiltration C0235896 | pulmonary infiltrates C0221013 | systemic mastocytosis C0221013 | systemic mast cell disease C0155686 | acute myocarditis C0152013 | adenocarcinoma of the lung C0085669 | acute leukemia C0079731 | b-cell lymphoma C0040053 | thrombosis C0039070 | syncope C0037284 | skin lesions C0037274 | skin disease C0034150 | purpura C0030499 | parasitic diseases C0027022 | myeloproliferative disorder C0027022 | myeloid neoplasm C0026986 | myelodysplastic syndrome C0026848 | muscle disorders C0026764 | plasma cell myeloma C0024305 | non-hodgkin's lymphoma C0024115 | lung diseases C0023493 | adult t cell leukemia C0023467 | acute myeloid leukemia C0023467 | acute myelogenous leukaemia C0023449 | acute lymphocytic leukemia (all) C0022660 | acute renal failure C0019618 | histiocytosis C0019214 | hepatosplenomegaly C0018916 | hemangioma C0015230 | skin rash C0013604 | oedema C0010073 | coronary vasospasm C0010073 | coronary artery spasm C0009324 | ulcerative colitis C0005424 | biliary tract disease C0002963 | variant angina C0002940 | aneurysms |
| Text Mined Symptom | UMLS | Name | Sentences' Count(Total Symptoms:24) C0027022 | myeloid neoplasm | 15 C0018188 | granuloma | 11 C0235896 | pulmonary infiltrates | 9 C0042384 | vasculitis | 8 C0023467 | acute myeloid leukemia | 5 C0018916 | hemangioma | 4 C0023449 | acute lymphoblastic leukemia | 4 C0037284 | skin lesions | 2 C0235896 | pulmonary infiltration | 2 C0009319 | colitis | 2 C0040053 | thrombosis | 2 C0221013 | systemic mastocytosis | 2 C0015230 | skin rash | 2 C0022660 | acute renal failure | 2 C0027022 | myeloproliferative disorder | 1 C0079748 | lymphoblastic lymphoma | 1 C0003873 | rheumatoid arthritis | 1 C0030499 | parasitic diseases | 1 C0010073 | coronary vasospasm | 1 C0242379 | lung cancer | 1 C0023467 | acute myelogenous leukaemia | 1 C0024228 | lymphadenopathy | 1 C0026975 | myelitis | 1 C0026986 | myelodysplastic syndrome | 1 |
Manually Genotype(Total Text Mining Genotypes:0) |
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| (Waiting for update.) |
All Snps(Total Genotypes:19) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| snpId | pubmedId | geneId | geneSymbol | diseaseId | sourceId | sentence | score | Year | geneSymbol_dbSNP | CHROMOSOME | POS | REF | ALT |
| rs121913507 | 26017288 | 3717 | JAK2 | umls:C0014457 | BeFree | Thus, there is a clear prognostic and therapeutic rationale for detection of KIT D816V and JAK2 V617F in the diagnostic work up of eosinophilia. | 0.001085767 | 2015 | KIT | 4 | 54733155 | A | T |
| rs121913507 | 26017288 | 3815 | KIT | umls:C0014457 | BeFree | Thus, there is a clear prognostic and therapeutic rationale for detection of KIT D816V and JAK2 V617F in the diagnostic work up of eosinophilia. | 0.001085767 | 2015 | KIT | 4 | 54733155 | A | T |
| rs121913507 | 17628645 | 3815 | KIT | umls:C0014457 | BeFree | KIT D816V-associated systemic mastocytosis with eosinophilia and FIP1L1/PDGFRA-associated chronic eosinophilic leukemia are distinct entities. | 0.001085767 | 2007 | KIT | 4 | 54733155 | A | T |
| rs121917894 | 17476358 | 5897 | RAG2 | umls:C0014457 | BeFree | These Rag2(R229Q/R229Q) mice showed oligoclonal T cells, absence of circulating B cells, and peripheral eosinophilia. | 0.000271442 | 2007 | RAG2;C11orf74 | 11 | 36593483 | C | T,A |
| rs12619285 | 19860791 | 9173 | IL1RL1 | umls:C0014457 | BeFree | We recruited 284 patients with NP in four participating hospitals in Belgium and 427 healthy controls, and genotyped 10 SNPs affecting eosinophilia (rs1420101 in IL1RL1, rs12619285 in IKZF2, rs4431128 in GATA2, rs4143832 in IL5, rs3184504 in SH2B3, rs2416257 in WDR36, rs2269426 in MHC, rs9494145 in MYB, rs748065 in GFRA2, and rs3939286 in IL33) using MALDI-TOF. | 0.000814326 | 2010 | LOC102725082 | 2 | 212959321 | A | G |
| rs1420101 | 19860791 | 9173 | IL1RL1 | umls:C0014457 | BeFree | We recruited 284 patients with NP in four participating hospitals in Belgium and 427 healthy controls, and genotyped 10 SNPs affecting eosinophilia (rs1420101 in IL1RL1, rs12619285 in IKZF2, rs4431128 in GATA2, rs4143832 in IL5, rs3184504 in SH2B3, rs2416257 in WDR36, rs2269426 in MHC, rs9494145 in MYB, rs748065 in GFRA2, and rs3939286 in IL33) using MALDI-TOF. | 0.000814326 | 2010 | IL1RL1 | 2 | 102341256 | C | T |
| rs2269426 | 19860791 | 9173 | IL1RL1 | umls:C0014457 | BeFree | We recruited 284 patients with NP in four participating hospitals in Belgium and 427 healthy controls, and genotyped 10 SNPs affecting eosinophilia (rs1420101 in IL1RL1, rs12619285 in IKZF2, rs4431128 in GATA2, rs4143832 in IL5, rs3184504 in SH2B3, rs2416257 in WDR36, rs2269426 in MHC, rs9494145 in MYB, rs748065 in GFRA2, and rs3939286 in IL33) using MALDI-TOF. | 0.000814326 | 2010 | TNXB | 6 | 32108722 | G | A |
| rs2416257 | 19860791 | 9173 | IL1RL1 | umls:C0014457 | BeFree | We recruited 284 patients with NP in four participating hospitals in Belgium and 427 healthy controls, and genotyped 10 SNPs affecting eosinophilia (rs1420101 in IL1RL1, rs12619285 in IKZF2, rs4431128 in GATA2, rs4143832 in IL5, rs3184504 in SH2B3, rs2416257 in WDR36, rs2269426 in MHC, rs9494145 in MYB, rs748065 in GFRA2, and rs3939286 in IL33) using MALDI-TOF. | 0.000814326 | 2010 | WDR36 | 5 | 111099792 | C | T |
| rs3184504 | 19860791 | 9173 | IL1RL1 | umls:C0014457 | BeFree | We recruited 284 patients with NP in four participating hospitals in Belgium and 427 healthy controls, and genotyped 10 SNPs affecting eosinophilia (rs1420101 in IL1RL1, rs12619285 in IKZF2, rs4431128 in GATA2, rs4143832 in IL5, rs3184504 in SH2B3, rs2416257 in WDR36, rs2269426 in MHC, rs9494145 in MYB, rs748065 in GFRA2, and rs3939286 in IL33) using MALDI-TOF. | 0.000814326 | 2010 | SH2B3 | 12 | 111446804 | T | C |
| rs376562815 | 23446743 | 4790 | NFKB1 | umls:C0014457 | BeFree | Recombinant IL-33 isoform with the G171S substitution had approximately 50% of activity of normal isoform in NF-κB-dependent reporter assay, and reduced bioactivity (∼65% of normal) to provoke eosinophilia when injected into mice. | 0.000271442 | 2013 | NFKB1;LOC101929401 | 4 | 102576961 | G | A |
| rs386626619 | 26017288 | 3717 | JAK2 | umls:C0014457 | BeFree | Thus, there is a clear prognostic and therapeutic rationale for detection of KIT D816V and JAK2 V617F in the diagnostic work up of eosinophilia. | 0.001085767 | 2015 | NA | NA | NA | NA | NA |
| rs386626619 | 26017288 | 3815 | KIT | umls:C0014457 | BeFree | Thus, there is a clear prognostic and therapeutic rationale for detection of KIT D816V and JAK2 V617F in the diagnostic work up of eosinophilia. | 0.001085767 | 2015 | NA | NA | NA | NA | NA |
| rs3939286 | 19860791 | 9173 | IL1RL1 | umls:C0014457 | BeFree | We recruited 284 patients with NP in four participating hospitals in Belgium and 427 healthy controls, and genotyped 10 SNPs affecting eosinophilia (rs1420101 in IL1RL1, rs12619285 in IKZF2, rs4431128 in GATA2, rs4143832 in IL5, rs3184504 in SH2B3, rs2416257 in WDR36, rs2269426 in MHC, rs9494145 in MYB, rs748065 in GFRA2, and rs3939286 in IL33) using MALDI-TOF. | 0.000814326 | 2010 | NA | 9 | 6210099 | T | C |
| rs4143832 | 19860791 | 9173 | IL1RL1 | umls:C0014457 | BeFree | We recruited 284 patients with NP in four participating hospitals in Belgium and 427 healthy controls, and genotyped 10 SNPs affecting eosinophilia (rs1420101 in IL1RL1, rs12619285 in IKZF2, rs4431128 in GATA2, rs4143832 in IL5, rs3184504 in SH2B3, rs2416257 in WDR36, rs2269426 in MHC, rs9494145 in MYB, rs748065 in GFRA2, and rs3939286 in IL33) using MALDI-TOF. | 0.000814326 | 2010 | NA | 5 | 132527285 | T | G |
| rs4431128 | 19860791 | 9173 | IL1RL1 | umls:C0014457 | BeFree | We recruited 284 patients with NP in four participating hospitals in Belgium and 427 healthy controls, and genotyped 10 SNPs affecting eosinophilia (rs1420101 in IL1RL1, rs12619285 in IKZF2, rs4431128 in GATA2, rs4143832 in IL5, rs3184504 in SH2B3, rs2416257 in WDR36, rs2269426 in MHC, rs9494145 in MYB, rs748065 in GFRA2, and rs3939286 in IL33) using MALDI-TOF. | 0.000814326 | 2010 | NA | 3 | 128532835 | C | T |
| rs748065 | 19860791 | 9173 | IL1RL1 | umls:C0014457 | BeFree | We recruited 284 patients with NP in four participating hospitals in Belgium and 427 healthy controls, and genotyped 10 SNPs affecting eosinophilia (rs1420101 in IL1RL1, rs12619285 in IKZF2, rs4431128 in GATA2, rs4143832 in IL5, rs3184504 in SH2B3, rs2416257 in WDR36, rs2269426 in MHC, rs9494145 in MYB, rs748065 in GFRA2, and rs3939286 in IL33) using MALDI-TOF. | 0.000814326 | 2010 | NA | 8 | 21820591 | A | G |
| rs77375493 | 26017288 | 3815 | KIT | umls:C0014457 | BeFree | Thus, there is a clear prognostic and therapeutic rationale for detection of KIT D816V and JAK2 V617F in the diagnostic work up of eosinophilia. | 0.001085767 | 2015 | JAK2;INSL6 | 9 | 5073770 | G | A,T |
| rs77375493 | 26017288 | 3717 | JAK2 | umls:C0014457 | BeFree | Thus, there is a clear prognostic and therapeutic rationale for detection of KIT D816V and JAK2 V617F in the diagnostic work up of eosinophilia. | 0.001085767 | 2015 | JAK2;INSL6 | 9 | 5073770 | G | A,T |
| rs9494145 | 19860791 | 9173 | IL1RL1 | umls:C0014457 | BeFree | We recruited 284 patients with NP in four participating hospitals in Belgium and 427 healthy controls, and genotyped 10 SNPs affecting eosinophilia (rs1420101 in IL1RL1, rs12619285 in IKZF2, rs4431128 in GATA2, rs4143832 in IL5, rs3184504 in SH2B3, rs2416257 in WDR36, rs2269426 in MHC, rs9494145 in MYB, rs748065 in GFRA2, and rs3939286 in IL33) using MALDI-TOF. | 0.000814326 | 2010 | NA | 6 | 135111414 | 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:52) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| CUI | ChemicalName | ChemicalID | CasRN | DiseaseName | DiseaseID | DirectEvidence | PubMedIDs | ||
| C0014457 | acetaminophen | D000082 | 103-90-2 | eosinophilia | MESH:D004802 | marker/mechanism | 23411599 | ||
| C0014457 | acetohexamide | D000092 | 968-81-0 | eosinophilia | MESH:D004802 | marker/mechanism | 2714585 | ||
| C0014457 | allopurinol | D000493 | 315-30-0 | eosinophilia | MESH:D004802 | marker/mechanism | 11450872 | ||
| C0014457 | aminoglutethimide | D000616 | 125-84-8 | eosinophilia | MESH:D004802 | marker/mechanism | 7091987 | ||
| C0014457 | amitriptyline | D000639 | 50-48-6 | eosinophilia | MESH:D004802 | therapeutic | 690091 | ||
| C0014457 | ampicillin | D000667 | 69-53-4 | eosinophilia | MESH:D004802 | marker/mechanism | 636917 | ||
| C0014457 | aztreonam | D001398 | 78110-38-0 | eosinophilia | MESH:D004802 | marker/mechanism | 2967033 | ||
| C0014457 | betamethasone | D001623 | 378-44-9 | eosinophilia | MESH:D004802 | therapeutic | 8535097 | ||
| C0014457 | carbamazepine | D002220 | 298-46-4 | eosinophilia | MESH:D004802 | marker/mechanism | 12005248 | ||
| C0014457 | celecoxib | D000068579 | - | eosinophilia | MESH:D004802 | marker/mechanism | 11177350 | ||
| C0014457 | cephalexin | D002506 | 15686-71-2 | eosinophilia | MESH:D004802 | marker/mechanism | 1242194 | ||
| C0014457 | cetirizine | D017332 | 83881-51-0 | eosinophilia | MESH:D004802 | therapeutic | 12689652 | ||
| C0014457 | chlorambucil | D002699 | 305-03-3 | eosinophilia | MESH:D004802 | marker/mechanism | 19122478 | ||
| C0014457 | chloramphenicol | D002701 | 56-75-7 | eosinophilia | MESH:D004802 | marker/mechanism | 4800729 | ||
| C0014457 | cimetidine | D002927 | 51481-61-9 | eosinophilia | MESH:D004802 | marker/mechanism | 1480549 | ||
| C0014457 | ciprofloxacin | D002939 | 85721-33-1 | eosinophilia | MESH:D004802 | marker/mechanism | 11476450 | ||
| C0014457 | clozapine | D003024 | 5786-21-0 | eosinophilia | MESH:D004802 | marker/mechanism | 11307364 | ||
| C0014457 | cyclophosphamide | D003520 | 50-18-0 | eosinophilia | MESH:D004802 | marker/mechanism | 11006010 | ||
| C0014457 | diclofenac | D004008 | 15307-86-5 | eosinophilia | MESH:D004802 | marker/mechanism | 16943303 | ||
| C0014457 | doxycycline | D004318 | 564-25-0 | eosinophilia | MESH:D004802 | marker/mechanism | 9145823 | ||
| C0014457 | enalapril | D004656 | 75847-73-3 | eosinophilia | MESH:D004802 | marker/mechanism | 16737005 | ||
| C0014457 | ethambutol | D004977 | 74-55-5 | eosinophilia | MESH:D004802 | marker/mechanism | 18583892 | ||
| C0014457 | fluconazole | D015725 | 86386-73-4 | eosinophilia | MESH:D004802 | marker/mechanism | 9309372 | ||
| C0014457 | flunisolide | C007734 | 3385/3/3 | eosinophilia | MESH:D004802 | therapeutic | 16111148 | ||
| C0014457 | imatinib mesylate | D000068877 | - | eosinophilia | MESH:D004802 | marker/mechanism | 18409077 | ||
| C0014457 | imipramine | D007099 | 50-49-7 | eosinophilia | MESH:D004802 | marker/mechanism | 7751253 | ||
| C0014457 | indomethacin | D007213 | 53-86-1 | eosinophilia | MESH:D004802 | therapeutic | 11298111 | ||
| C0014457 | lamotrigine | C047781 | 84057-84-1 | eosinophilia | MESH:D004802 | marker/mechanism | 19221540 | ||
| C0014457 | linezolid | D000069349 | - | eosinophilia | MESH:D004802 | marker/mechanism | 18044266 | ||
| C0014457 | methylphenidate | D008774 | 113-45-1 | eosinophilia | MESH:D004802 | marker/mechanism | 7751253 | ||
| C0014457 | mexiletine | D008801 | 31828-71-4 | eosinophilia | MESH:D004802 | marker/mechanism | 9414061 | ||
| C0014457 | mitomycin | D016685 | 1950/7/7 | eosinophilia | MESH:D004802 | marker/mechanism | 11912421 | ||
| C0014457 | mitoxantrone | D008942 | 65271-80-9 | eosinophilia | MESH:D004802 | marker/mechanism | 19393848 | ||
| C0014457 | montelukast | C093875 | 158966-92-8 | eosinophilia | MESH:D004802 | marker/mechanism | 10335014 | ||
| C0014457 | nevirapine | D019829 | 129618-40-2 | eosinophilia | MESH:D004802 | marker/mechanism | 11450872 | ||
| C0014457 | nicotine | D009538 | - | eosinophilia | MESH:D004802 | marker/mechanism | 12575837 | ||
| C0014457 | olanzapine | C076029 | 132539-06-1 | eosinophilia | MESH:D004802 | marker/mechanism | 11217818 | ||
| C0014457 | omeprazole | D009853 | 73590-58-6 | eosinophilia | MESH:D004802 | marker/mechanism | 10566755 | ||
| C0014457 | phenindione | D010630 | 1983/12/5 | eosinophilia | MESH:D004802 | marker/mechanism | 139882 | ||
| C0014457 | phenytoin | D010672 | 57-41-0 | eosinophilia | MESH:D004802 | marker/mechanism | 10698845 | ||
| C0014457 | piperacillin | D010878 | 61477-96-1 | eosinophilia | MESH:D004802 | marker/mechanism | 8413777 | ||
| C0014457 | ramipril | D017257 | 87333-19-5 | eosinophilia | MESH:D004802 | marker/mechanism | 17351545 | ||
| C0014457 | rofecoxib | C116926 | - | eosinophilia | MESH:D004802 | marker/mechanism | 15892770 | ||
| C0014457 | sulindac | D013467 | 38194-50-2 | eosinophilia | MESH:D004802 | marker/mechanism | 20013860 | ||
| C0014457 | thiotepa | D013852 | 52-24-4 | eosinophilia | MESH:D004802 | marker/mechanism | 7495132 | ||
| C0014457 | valproic acid | D014635 | 99-66-1 | eosinophilia | MESH:D004802 | marker/mechanism | 14515923 | ||
| C0014457 | vancomycin | D014640 | 1404-90-6 | eosinophilia | MESH:D004802 | marker/mechanism | 18607115 | ||
| C0014457 | vincristine | D014750 | - | eosinophilia | MESH:D004802 | marker/mechanism | 4551437 | ||
| C0014457 | vitamin e | D014810 | 1406-18-4 | eosinophilia | MESH:D004802 | marker/mechanism | 11913585 | ||
| C0014457 | zafirlukast | C062735 | 107753-78-6 | eosinophilia | MESH:D004802 | marker/mechanism | 12189465 | ||
| C0014457 | zafirlukast | C062735 | 107753-78-6 | eosinophilia | MESH:D004802 | therapeutic | 12689652 | ||
| C0014457 | zidovudine | D015215 | 30516-87-1 | eosinophilia | MESH:D004802 | marker/mechanism | 11434632 | ||
FDA approved drug and dosage information(Total Drugs:42) | ||||||||
|---|---|---|---|---|---|---|---|---|
| DiseaseID | Drug_name | active_ingredients | strength | Dosage Form/Route | Marketing Status | TE code | RLD | RS |
| MESH:D004802 | 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:D004802 | 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:D004802 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| MESH:D004802 | omeprazole | omeprazole | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
| MESH:D004802 | zyvox | linezolid | 400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | TABLET;ORAL | Discontinued | None | Yes | No |
| MESH:D004802 | zyvox | linezolid | 200MG/100ML (2MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | No |
| MESH:D004802 | zyvox | linezolid | 100MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
| MESH:D004802 | zyvox | linezolid | 400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons | TABLET;ORAL | Discontinued | None | Yes | No |
| MESH:D004802 | zyvox | linezolid | 200MG/100ML (2MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | No |
| MESH:D004802 | zyvox | linezolid | 100MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | Yes |
| MESH:D004802 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004802 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004802 | lamictal | lamotrigine | 100MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004802 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D004802 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D004802 | lamictal xr | lamotrigine | 25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| MESH:D004802 | cipro | ciprofloxacin | 400MG/40ML (10MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| MESH:D004802 | cipro | ciprofloxacin | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | No |
| MESH:D004802 | vioxx | rofecoxib | 12.5MG | TABLET;ORAL | Discontinued | None | No | No |
| MESH:D004802 | vioxx | rofecoxib | 12.5MG/5ML | SUSPENSION;ORAL | Discontinued | None | No | No |
| MESH:D004802 | vioxx | rofecoxib | 12.5MG | TABLET; ORAL | Discontinued | None | No | No |
| MESH:D004802 | daytrana | methylphenidate | 10MG/9HR (1.1MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | No |
| MESH:D004802 | daytrana | methylphenidate | 10MG/9HR (1.1MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | No |
| MESH:D004802 | daytrana | methylphenidate | 10MG/9HR (1.1MG/HR) | FILM, EXTENDED RELEASE;TRANSDERMAL | Prescription | None | Yes | No |
| MESH:D004802 | 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:D004802 | gleevec | imatinib mesylate | EQ 100MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004802 | celebrex | celecoxib | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MESH:D004802 | celebrex | celecoxib | 100MG | CAPSULE;ORAL | Prescription | None | No | No |
| MESH:D004802 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004802 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D004802 | zyprexa | olanzapine | 2.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| MESH:D004802 | zyprexa | olanzapine | 10MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AP | Yes | Yes |
| MESH:D004802 | retrovir | zidovudine | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| MESH:D004802 | retrovir | zidovudine | 50MG/5ML | SYRUP;ORAL | Prescription | AA | Yes | Yes |
| MESH:D004802 | retrovir | zidovudine | 10MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| MESH:D004802 | retrovir | zidovudine | 200MG | TABLET;ORAL | Discontinued | None | No | No |
| MESH:D004802 | zidovudine | zidovudine | 60MG | TABLET;ORAL | Discontinued | None | No | No |
| MESH:D004802 | zidovudine | zidovudine | 60MG | TABLET;ORAL | Discontinued | None | No | No |
| MESH:D004802 | ofirmev | acetaminophen | 1GM/100ML (10MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | Yes |
| MESH:D004802 | ofirmev | acetaminophen | 1GM/100ML (10MG/ML) | SOLUTION;IV (INFUSION) | Prescription | AP | Yes | Yes |
| MESH:D004802 | acetaminophen | acetaminophen | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | None | Yes | Yes |
| MESH:D004802 | acetaminophen | acetaminophen | 650MG | SUPPOSITORY;RECTAL | Over-the-counter | None | Yes | Yes |
FDA labeling changes(Total Drugs:42) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:D004802 | 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:D004802 | 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:D004802 | 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:D004802 | 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:D004802 | 12/19/2002 | zyvox | linezolid | Nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant infections caused by susceptible strains | Extended age range down to birth for nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections and vancomycin-resistant infections. Safety and efficacy extrapolated from studies in adults and supported by PK and comparator-controlled studies in patients from birth to 11 years Extended age range down to 5 years of age for uncomplicated skin and skin structure infections based upon a comparator-controlled study in 5 to 17 year olds Clearance of linezolid varies as a function of age; As age of pediatric patients increases, clearance gradually decreases, and by adolescence mean clearance values approach those observed in adults Pediatric patients exhibit wider variability in clearance and systemic exposure (AUC) compared with adults New every 8 hours dosing regimen for pediatric patients birth to 11 years of age and every 12 hours dosing regimen for pediatric patients 12 years and older Information on PK parameters, AE profile, laboratory changes, dosing, and clinical studies | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D004802 | 12/19/2002 | zyvox | linezolid | Nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant infections caused by susceptible strains | Extended age range down to birth for nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections and vancomycin-resistant infections. Safety and efficacy extrapolated from studies in adults and supported by PK and comparator-controlled studies in patients from birth to 11 years Extended age range down to 5 years of age for uncomplicated skin and skin structure infections based upon a comparator-controlled study in 5 to 17 year olds Clearance of linezolid varies as a function of age; As age of pediatric patients increases, clearance gradually decreases, and by adolescence mean clearance values approach those observed in adults Pediatric patients exhibit wider variability in clearance and systemic exposure (AUC) compared with adults New every 8 hours dosing regimen for pediatric patients birth to 11 years of age and every 12 hours dosing regimen for pediatric patients 12 years and older Information on PK parameters, AE profile, laboratory changes, dosing, and clinical studies | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D004802 | 12/19/2002 | zyvox | linezolid | Nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant infections caused by susceptible strains | Extended age range down to birth for nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections and vancomycin-resistant infections. Safety and efficacy extrapolated from studies in adults and supported by PK and comparator-controlled studies in patients from birth to 11 years Extended age range down to 5 years of age for uncomplicated skin and skin structure infections based upon a comparator-controlled study in 5 to 17 year olds Clearance of linezolid varies as a function of age; As age of pediatric patients increases, clearance gradually decreases, and by adolescence mean clearance values approach those observed in adults Pediatric patients exhibit wider variability in clearance and systemic exposure (AUC) compared with adults New every 8 hours dosing regimen for pediatric patients birth to 11 years of age and every 12 hours dosing regimen for pediatric patients 12 years and older Information on PK parameters, AE profile, laboratory changes, dosing, and clinical studies | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D004802 | 12/5/2005 | zyvox | linezolid | Central nervous system infections | PK data in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF) concentrations; therapeutic concentrations were not consistently achieved or maintained in the CSF Use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended Additional information on efficacy in pediatric patients with infectious vancomycin-resistant Enterococcus faecium | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D004802 | 12/5/2005 | zyvox | linezolid | Central nervous system infections | PK data in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF) concentrations; therapeutic concentrations were not consistently achieved or maintained in the CSF Use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended Additional information on efficacy in pediatric patients with infectious vancomycin-resistant Enterococcus faecium | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D004802 | 12/5/2005 | zyvox | linezolid | Central nervous system infections | PK data in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF) concentrations; therapeutic concentrations were not consistently achieved or maintained in the CSF Use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended Additional information on efficacy in pediatric patients with infectious vancomycin-resistant Enterococcus faecium | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D004802 | 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:D004802 | 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:D004802 | 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:D004802 | 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:D004802 | 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:D004802 | 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:D004802 | 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:D004802 | 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:D004802 | 08/19/2004 | vioxx | rofecoxib | Pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis | Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib) due to safety concerns on September 30, 2004. | Labeling | B | - | - | - | Merck | 02/18/2004 | FALSE' |
| MESH:D004802 | 08/19/2004 | vioxx | rofecoxib | Pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis | Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib) due to safety concerns on September 30, 2004. | Labeling | B | - | - | - | Merck | 02/18/2004 | FALSE' |
| MESH:D004802 | 08/19/2004 | vioxx | rofecoxib | Pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis | Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib) due to safety concerns on September 30, 2004. | Labeling | B | - | - | - | Merck | 02/18/2004 | FALSE' |
| MESH:D004802 | 6/4/2006 | daytrana | methylphenidate | ADHD | Summary is pending | Labeling | - | P | - | - | Shire | - | FALSE' |
| MESH:D004802 | 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:D004802 | 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:D004802 | 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:D004802 | 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:D004802 | 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:D004802 | 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:D004802 | 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:D004802 | 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:D004802 | 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:D004802 | 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:D004802 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D004802 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D004802 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D004802 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D004802 | 09/19/2008 | retrovir syrup, capsules and tablets | zidovudine | Used in combination with 18 other antiretroviral agents for the treatment of HIV-1 infection | Dosing and administration information provided to children 6 weeks to less than 18 years of age Macrocytosis was reported in the majority of pediatric patients receiving Retrovir 180 mg/m2 every 6 hours in open-label studies New dosing regimen | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D004802 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D004802 | 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:D004802 | 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:D004802 | 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:D004802 | 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 |