PedAM

Pediatric Disease Annotations & Medicines


	myoclonus

Disease ID	1123
Disease	myoclonus
Definition	Involuntary shock-like contractions, irregular in rhythm and amplitude, followed by relaxation, of a muscle or a group of muscles. This condition may be a feature of some CENTRAL NERVOUS SYSTEM DISEASES; (e.g., EPILEPSY, MYOCLONIC). Nocturnal myoclonus is the principal feature of the NOCTURNAL MYOCLONUS SYNDROME. (From Adams et al., Principles of Neurology, 6th ed, pp102-3).
Synonym	disorder characterised by myoclonus disorder characterized by myoclonus involuntary muscle jerking jerk, myoclonic jerking, myoclonic jerks - myoclonic jerks, myoclonic myoclonic disorder myoclonic disorder (disorder) myoclonic jerk myoclonic jerking myoclonic jerks myoclonus (finding) myoclonus [disease/finding] myoclonus disorder myoclonus disorder &/or observation myoclonus disorder &/or observation (disorder) myoclonus nos myoclonus nos (disorder)
ICD10	ICD10CM:G25.3
UMLS	C0027066
MeSH	D009207
SNOMED-CT	SNOMEDCT_US_2016_09_01:127324008;SNOMEDCT_US_2016_09_01:17450006
Comorbidity	UMLS \| Disease \| Sentences' Count(Total Sentences:82) C0014070 \| encephalomyelitis \| 23 C0004134 \| ataxia \| 9 C0497327 \| dementia \| 8 C0014544 \| epilepsy \| 6 C0027819 \| neuroblastoma \| 6 C0743039 \| progressive dementia \| 4 C0042769 \| virus infection \| 3 C0002395 \| alzheimer disease \| 2 C0014544 \| epilepsia \| 2 C0035078 \| renal failure \| 2 C0026934 \| mycoplasma \| 2 C0014038 \| encephalitis \| 2 C0007758 \| cerebellar ataxia \| 2 C0026884 \| mutism \| 2 C0085543 \| epilepsia partialis continua \| 2 C0013421 \| dystonia \| 2 C0030567 \| parkinson's disease \| 2 C0032302 \| mycoplasma pneumonia \| 2 C0032285 \| pneumoniae \| 2 C0751583 \| west nile encephalitis \| 1 C0018552 \| hamartoma \| 1 C0003635 \| apraxia \| 1 C0027819 \| neuroblastomas \| 1 C0007570 \| celiac disease \| 1 C0242379 \| lung cancer \| 1 C0752120 \| spinocerebellar ataxia type 1 \| 1 C0006142 \| breast cancer \| 1 C0022658 \| nephropathy \| 1 C0024408 \| machado-joseph disease \| 1 C0013384 \| abnormal movements \| 1 C0017205 \| gaucher disease \| 1 C0023788 \| whipple's disease \| 1 C0023264 \| leigh syndrome \| 1 C0162283 \| nephrogenic diabetes insipidus \| 1 C0014547 \| focal epilepsy \| 1 C0206716 \| ganglioglioma \| 1 C0026780 \| mumps \| 1 C0878544 \| cardiomyopathy \| 1 C0270853 \| juvenile myoclonic epilepsy \| 1 C0014544 \| epilepsies \| 1 C0003537 \| aphasia \| 1 C0162635 \| angelman syndrome \| 1 C0016037 \| fibrodysplasia ossificans progressiva \| 1 C0019196 \| hepatitis c infection \| 1 C0752347 \| dementia with lewy bodies \| 1 C0270855 \| early myoclonic encephalopathy \| 1 C0007193 \| dilated cardiomyopathy \| 1 C0002395 \| alzheimer dementia \| 1 C0022336 \| creutzfeldt-jakob disease \| 1 C0007131 \| non-small cell lung cancer \| 1 C0011570 \| depression \| 1 C0019196 \| hepatitis c \| 1 C0038868 \| progressive supranuclear palsy \| 1 C0024408 \| joseph disease \| 1 C0432442 \| 18p deletion syndrome \| 1 C0149782 \| squamous cell lung carcinoma \| 1 C0027404 \| narcolepsy \| 1 C0027765 \| neurological disorder \| 1 C0751778 \| progressive myoclonic epilepsy \| 1 C0393571 \| multiple system atrophy \| 1 C0040100 \| thymoma \| 1 C0013384 \| dyskinesia \| 1 C0007131 \| non-small-cell lung carcinoma \| 1 C0751651 \| mitochondrial disorder \| 1 C0024523 \| malabsorption \| 1 C0026709 \| mps vi \| 1 C0038220 \| status epilepticus \| 1 C0684249 \| lung carcinoma \| 1 C0013384 \| abnormal movement \| 1 C0019158 \| hepatitis \| 1 C1096063 \| intractable epilepsy \| 1 C0018378 \| guillain-barre syndrome \| 1 C0751651 \| mitochondrial disorders \| 1 C0270612 \| leukoencephalopathy \| 1 C0751785 \| unverricht-lundborg disease \| 1 C0019151 \| hepatic encephalopathy \| 1 C0149925 \| small cell lung cancer \| 1 C0206718 \| ganglioneuroblastoma \| 1 C0030783 \| pellagra \| 1 C1261175 \| pontocerebellar hypoplasia \| 1 C0238301 \| nasopharyngeal carcinoma \| 1 C1834580 \| ramsay hunt syndrome \| 1
Curated Gene	Entrez_id \| Symbol \| Resource(Total Genes:1) MECP2 \| 4204 \| CTD_human
Inferring Gene	(Waiting for update.)
Text Mined Gene	(Waiting for update.)
Locus	(Waiting for update.)

Disease ID	1123
Disease	myoclonus
Integrated Phenotype	(Waiting for update.)
Text Mined Phenotype	HPO \| Name \| Sentences' Count(Total Phenotypes:66) HP:0001251 \| Ataxia \| 10 HP:0003200 \| Ragged-red fibers \| 10 HP:0000726 \| Dementia \| 8 HP:0003006 \| Neuroblastoma \| 6 HP:0000360 \| Ringing in the ears \| 6 HP:0001250 \| Seizures \| 5 HP:0001298 \| Encephalopathy \| 4 HP:0002063 \| Muscle rigidity \| 3 HP:0001259 \| Coma \| 2 HP:0001332 \| Dystonia \| 2 HP:0001297 \| Cerebral vascular events \| 2 HP:0001337 \| Tremor \| 2 HP:0002383 \| Encephalitis \| 2 HP:0002664 \| Neoplasia \| 2 HP:0100318 \| Lafora bodies \| 2 HP:0030731 \| Carcinoma \| 2 HP:0000083 \| Renal insufficiency \| 2 HP:0001300 \| Parkinsonism \| 2 HP:0012672 \| Akinetic mutism \| 2 HP:0012847 \| Epilepsia partialis continua \| 2 HP:0000010 \| Frequent urinary tract infections \| 2 HP:0002300 \| Muteness \| 2 HP:0002511 \| Late-onset form of familial Alzheimer disease \| 2 HP:0002024 \| Intestinal malabsorption \| 1 HP:0002380 \| Muscle twitch \| 1 HP:0003324 \| Muscle weakness, diffuse \| 1 HP:0100522 \| Thymoma \| 1 HP:0001945 \| Fever \| 1 HP:0002073 \| Cerebellar ataxia, progressive \| 1 HP:0001638 \| Cardiomyopathy \| 1 HP:0012115 \| Liver inflammation \| 1 HP:0001260 \| Dysarthric speech \| 1 HP:0008629 \| Pulsatile tinnitus \| 1 HP:0012538 \| Gluten sensitivity \| 1 HP:0002480 \| Hepatic encephalopathy \| 1 HP:0030358 \| Non-small cell lung carcinoma \| 1 HP:0030050 \| Narcolepsy \| 1 HP:0002133 \| Status epilepticus \| 1 HP:0001289 \| Confusion \| 1 HP:0000112 \| Nephropathy \| 1 HP:0030692 \| Brain tumor \| 1 HP:0001321 \| Small cerebellum \| 1 HP:0030357 \| Small cell lung carcinoma \| 1 HP:0002381 \| Aphasia \| 1 HP:0009806 \| Nephrogenic diabetes insipidus \| 1 HP:0011675 \| Arrhythmias \| 1 HP:0010543 \| Opsoclonus \| 1 HP:0100660 \| Dyskinesis \| 1 HP:0002080 \| Intention tremor \| 1 HP:0003002 \| Breast carcinoma \| 1 HP:0000734 \| Disinhibition \| 1 HP:0001695 \| Cardiac arrest \| 1 HP:0001644 \| Congestive cardiomyopathy \| 1 HP:0002352 \| Leukoencephalopathy \| 1 HP:0002186 \| Apraxia \| 1 HP:0000716 \| Depression \| 1 HP:0001336 \| Myoclonic jerks \| 1 HP:0100543 \| Cognitive deficits \| 1 HP:0010566 \| Hamartoma \| 1 HP:0012164 \| Asterixis \| 1 HP:0002608 \| Celiac disease \| 1 HP:0100315 \| Lewy bodies \| 1 HP:0006747 \| Ganglioneuroblastoma \| 1 HP:0001268 \| Mental deterioration \| 1 HP:0002015 \| Swallowing difficulty \| 1 HP:0030359 \| Squamous cell lung carcinoma \| 1

Disease ID	1123
Disease	myoclonus
Manually Symptom	(Waiting for update.)
Text Mined Symptom	UMLS \| Name \| Sentences' Count(Total Symptoms:4) C0497327 \| dementia \| 8 C0743039 \| progressive dementia \| 4 C0232766 \| asterixis \| 1 C0235169 \| excitability \| 1

Manually Genotype(Total Text Mining Genotypes:0)
(Waiting for update.)

All Snps(Total Genotypes:3)
snpId	pubmedId	geneId	geneSymbol	diseaseId	sourceId	sentence	score	Year	geneSymbol_dbSNP	CHROMOSOME	POS	REF	ALT
rs387906881	24458321	9570	GOSR2	umls:C0027066	BeFree	Recently, a mutation in the GOSR2 gene (c.430G>T, p.Gly144Trp) was reported in 6 patients with childhood-onset progressive ataxia and myoclonus.	0.000271442	2013	GOSR2	17	46935122	G	T
rs63750634	12686406	5663	PSEN1	umls:C0027066	BeFree	A novel mutation (L250V) in the presenilin 1 gene in a Japanese familial Alzheimer's disease with myoclonus and generalized convulsion.	0.003810118	2003	PSEN1	14	73192843	T	G
rs63751210	11764087	5663	PSEN1	umls:C0027066	BeFree	Ectopic white matter neurons, a developmental abnormality that may be caused by the PSEN1 S169L mutation in a case of familial AD with myoclonus and seizures.	0.003810118	2001	PSEN1	14	73186878	C	T

GWASdb Annotation(Total Genotypes:0)
(Waiting for update.)

GWASdb Snp Trait(Total Genotypes:0)
(Waiting for update.)

Mapped by lexical matching(Total Items:0)
(Waiting for update.)

Mapped by homologous gene(Total Items:0)
(Waiting for update.)

Chemical(Total Drugs:92)
CUI	ChemicalName	ChemicalID	CasRN	DiseaseName	DiseaseID	DirectEvidence	PubMedIDs
C0027066	acetaminophen	D000082	103-90-2	myoclonus	MESH:D009207	marker/mechanism	15459624
C0027066	acetylcysteine	D000111	616-91-1	myoclonus	MESH:D009207	marker/mechanism	15459624
C0027066	amitriptyline	D000639	50-48-6	myoclonus	MESH:D009207	marker/mechanism	3827519
C0027066	amlodipine	D017311	88150-42-9	myoclonus	MESH:D009207	marker/mechanism	19332219
C0027066	atenolol	D001262	29122-68-7	myoclonus	MESH:D009207	marker/mechanism	11160978
C0027066	atropine	D001285	51-55-8	myoclonus	MESH:D009207	therapeutic	1620139
C0027066	baclofen	D001418	1134-47-0	myoclonus	MESH:D009207	marker/mechanism	1874611
C0027066	baclofen	D001418	1134-47-0	myoclonus	MESH:D009207	therapeutic	6118280
C0027066	betamethasone	D001623	378-44-9	myoclonus	MESH:D009207	marker/mechanism	10955182
C0027066	bupivacaine	D002045	2180-92-9	myoclonus	MESH:D009207	marker/mechanism	14597801
C0027066	buspirone	D002065	36505-84-7	myoclonus	MESH:D009207	marker/mechanism	10928399
C0027066	busulfan	D002066	55-98-1	myoclonus	MESH:D009207	marker/mechanism	2596777
C0027066	carbachol	D002217	-	myoclonus	MESH:D009207	marker/mechanism	7078834
C0027066	carbamazepine	D002220	298-46-4	myoclonus	MESH:D009207	marker/mechanism	16116141
C0027066	carbamazepine	D002220	298-46-4	myoclonus	MESH:D009207	therapeutic	7665541
C0027066	carbidopa	D002230	38821-49-7	myoclonus	MESH:D009207	marker/mechanism	2986413
C0027066	carbidopa	D002230	38821-49-7	myoclonus	MESH:D009207	therapeutic	6997735
C0027066	cefmetazole	D015311	56796-20-4	myoclonus	MESH:D009207	marker/mechanism	3233864
C0027066	cefotiam	D015310	61622-34-2	myoclonus	MESH:D009207	marker/mechanism	15221158
C0027066	ceftazidime	D002442	78439-06-2	myoclonus	MESH:D009207	marker/mechanism	14671069
C0027066	chlorambucil	D002699	305-03-3	myoclonus	MESH:D009207	marker/mechanism	12755202
C0027066	chlorpromazine	D002746	50-53-3	myoclonus	MESH:D009207	marker/mechanism	2860211
C0027066	cimetidine	D002927	51481-61-9	myoclonus	MESH:D009207	marker/mechanism	2860211
C0027066	ciprofloxacin	D002939	85721-33-1	myoclonus	MESH:D009207	marker/mechanism	15133830
C0027066	citalopram	D015283	59729-33-8	myoclonus	MESH:D009207	marker/mechanism	16702909
C0027066	clobazam	C012255	22316-47-8	myoclonus	MESH:D009207	therapeutic	98317
C0027066	clonidine	D003000	4205-90-7	myoclonus	MESH:D009207	therapeutic	11506132
C0027066	clozapine	D003024	5786-21-0	myoclonus	MESH:D009207	marker/mechanism	10435384
C0027066	codeine	D003061	76-57-3	myoclonus	MESH:D009207	marker/mechanism	5284823
C0027066	cycloserine	D003523	68-41-7	myoclonus	MESH:D009207	marker/mechanism	943260
C0027066	cysteamine	D003543	60-23-1	myoclonus	MESH:D009207	marker/mechanism	3110644
C0027066	diclofenac	D004008	15307-86-5	myoclonus	MESH:D009207	marker/mechanism	224483
C0027066	droperidol	D004329	548-73-2	myoclonus	MESH:D009207	therapeutic	7027723
C0027066	enflurane	D004737	13838-16-9	myoclonus	MESH:D009207	marker/mechanism	7448613
C0027066	erythromycin	D004917	114-07-8	myoclonus	MESH:D009207	marker/mechanism	5284823
C0027066	etomidate	D005045	33125-97-2	myoclonus	MESH:D009207	marker/mechanism	1015219
C0027066	floxuridine	D005467	50-91-9	myoclonus	MESH:D009207	marker/mechanism	2943526
C0027066	fluoxetine	D005473	54910-89-3	myoclonus	MESH:D009207	marker/mechanism	10928399
C0027066	fluoxetine	D005473	54910-89-3	myoclonus	MESH:D009207	therapeutic	520416
C0027066	fluvoxamine	D016666	54739-18-3	myoclonus	MESH:D009207	marker/mechanism	19050415
C0027066	gadodiamide	C064925	-	myoclonus	MESH:D009207	marker/mechanism	9763378
C0027066	gemcitabine	C056507	103882-84-4	myoclonus	MESH:D009207	marker/mechanism	15370618
C0027066	haloperidol	D006220	52-86-8	myoclonus	MESH:D009207	marker/mechanism	19526195
C0027066	hydromorphone	D004091	466-99-9	myoclonus	MESH:D009207	marker/mechanism	1376887
C0027066	ifosfamide	D007069	3778-73-2	myoclonus	MESH:D009207	marker/mechanism	12084448
C0027066	imipramine	D007099	50-49-7	myoclonus	MESH:D009207	marker/mechanism	2860211
C0027066	lamotrigine	C047781	84057-84-1	myoclonus	MESH:D009207	marker/mechanism	16157917
C0027066	lansoprazole	D064747	-	myoclonus	MESH:D009207	marker/mechanism	15037850
C0027066	lidocaine	D008012	137-58-6	myoclonus	MESH:D009207	marker/mechanism	18486797
C0027066	lidocaine	D008012	137-58-6	myoclonus	MESH:D009207	therapeutic	20108006
C0027066	linezolid	D000069349	-	myoclonus	MESH:D009207	marker/mechanism	18624020
C0027066	lorazepam	D008140	846-49-1	myoclonus	MESH:D009207	marker/mechanism	7727612
C0027066	lorazepam	D008140	846-49-1	myoclonus	MESH:D009207	therapeutic	17516482
C0027066	mefloquine	D015767	53230-10-7	myoclonus	MESH:D009207	marker/mechanism	12410053
C0027066	metformin	D008687	657-24-9	myoclonus	MESH:D009207	marker/mechanism	14984458
C0027066	methadone	D008691	76-99-3	myoclonus	MESH:D009207	marker/mechanism	11406880
C0027066	methohexital	D008723	18652-93-2	myoclonus	MESH:D009207	marker/mechanism	5774518
C0027066	dextromethorphan	D003915	125-71-3	myoclonus	MESH:D009207	marker/mechanism	21228393
C0027066	methylphenidate	D008774	113-45-1	myoclonus	MESH:D009207	marker/mechanism	7854515
C0027066	methysergide	D008784	361-37-5	myoclonus	MESH:D009207	marker/mechanism	2986413
C0027066	methysergide	D008784	361-37-5	myoclonus	MESH:D009207	therapeutic	1079721
C0027066	mexiletine	D008801	31828-71-4	myoclonus	MESH:D009207	marker/mechanism	8250327
C0027066	morphine	D009020	57-27-2	myoclonus	MESH:D009207	marker/mechanism	10365727
C0027066	nicotine	D009538	-	myoclonus	MESH:D009207	marker/mechanism	1736170
C0027066	nortriptyline	D009661	72-69-5	myoclonus	MESH:D009207	marker/mechanism	1390620
C0027066	olanzapine	C076029	132539-06-1	myoclonus	MESH:D009207	marker/mechanism	10770480
C0027066	olanzapine	C076029	132539-06-1	myoclonus	MESH:D009207	therapeutic	15965316
C0027066	pefloxacin	D015366	70458-92-3	myoclonus	MESH:D009207	marker/mechanism	1299981
C0027066	pentobarbital	D010424	76-74-4	myoclonus	MESH:D009207	therapeutic	12925183
C0027066	phenytoin	D010672	57-41-0	myoclonus	MESH:D009207	marker/mechanism	11310291
C0027066	phenytoin	D010672	57-41-0	myoclonus	MESH:D009207	therapeutic	19448237
C0027066	picrotoxin	D010852	124-87-8	myoclonus	MESH:D009207	marker/mechanism	12459828
C0027066	pilocarpine	D010862	92-13-7	myoclonus	MESH:D009207	marker/mechanism	1324090
C0027066	pravastatin	D017035	81093-37-0	myoclonus	MESH:D009207	marker/mechanism	11160978
C0027066	prazosin	D011224	19216-56-9	myoclonus	MESH:D009207	marker/mechanism	11160978
C0027066	prazosin	D011224	19216-56-9	myoclonus	MESH:D009207	therapeutic	37558
C0027066	propranolol	D011433	525-66-6	myoclonus	MESH:D009207	therapeutic	2347607
C0027066	reserpine	D012110	50-55-5	myoclonus	MESH:D009207	therapeutic	12860512
C0027066	ropivacaine	C037663	84057-95-4	myoclonus	MESH:D009207	marker/mechanism	19837813
C0027066	tacrine	D013619	321-64-2	myoclonus	MESH:D009207	marker/mechanism	9489553
C0027066	tacrolimus	D016559	109581-93-3	myoclonus	MESH:D009207	marker/mechanism	17564783
C0027066	thiethylperazine	D013847	1420-55-9	myoclonus	MESH:D009207	marker/mechanism	2475196
C0027066	thiopental	D013874	76-75-5	myoclonus	MESH:D009207	therapeutic	19448237
C0027066	ticlopidine	D013988	55142-85-3	myoclonus	MESH:D009207	marker/mechanism	11160978
C0027066	topiramate	C052342	97240-79-4	myoclonus	MESH:D009207	marker/mechanism	19050415
C0027066	tramadol	D014147	27203-92-5	myoclonus	MESH:D009207	marker/mechanism	14633768
C0027066	tranexamic acid	D014148	1197-18-8	myoclonus	MESH:D009207	marker/mechanism	12640092
C0027066	trimethoprim	D014295	738-70-5	myoclonus	MESH:D009207	marker/mechanism	18303133
C0027066	triprolidine	D014311	486-12-4	myoclonus	MESH:D009207	marker/mechanism	7110997
C0027066	valproic acid	D014635	99-66-1	myoclonus	MESH:D009207	marker/mechanism	15380868
C0027066	valproic acid	D014635	99-66-1	myoclonus	MESH:D009207	therapeutic	15701074
C0027066	vigabatrin	D020888	60643-86-9	myoclonus	MESH:D009207	marker/mechanism	11143506

FDA approved drug and dosage information(Total Drugs:47)
DiseaseID	Drug_name	active_ingredients	strength	Dosage Form/Route	Marketing Status	TE code	RLD	RS
MESH:D009207	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:D009207	zyvox	linezolid	200MG/100ML (2MG/ML)	SOLUTION;IV (INFUSION)	Prescription	AP	Yes	No
MESH:D009207	zyvox	linezolid	100MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	Yes	Yes
MESH:D009207	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:D009207	zyvox	linezolid	200MG/100ML (2MG/ML)	SOLUTION;IV (INFUSION)	Prescription	AP	Yes	No
MESH:D009207	zyvox	linezolid	100MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	Yes	Yes
MESH:D009207	busulfex	busulfan	6MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
MESH:D009207	lamictal	lamotrigine	100MG	TABLET;ORAL	Prescription	AB	Yes	No
MESH:D009207	lamictal	lamotrigine	100MG	TABLET;ORAL	Prescription	AB	Yes	No
MESH:D009207	lamictal	lamotrigine	100MG	TABLET;ORAL	Prescription	AB	Yes	No
MESH:D009207	lamictal xr	lamotrigine	25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
MESH:D009207	lamictal xr	lamotrigine	25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
MESH:D009207	lamictal xr	lamotrigine	25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
MESH:D009207	cipro	ciprofloxacin	400MG/40ML (10MG/ML)	INJECTABLE;INJECTION	Discontinued	None	Yes	No
MESH:D009207	cipro	ciprofloxacin	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	Yes	No
MESH:D009207	prevacid	lansoprazole	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	AB	Yes	No
MESH:D009207	prevacid	lansoprazole	15MG/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Discontinued	None	No	No
MESH:D009207	prevacid	lansoprazole	15MG	TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL	Prescription	None	Yes	No
MESH:D009207	prevacid	lansoprazole	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	AB	Yes	No
MESH:D009207	prevacid	lansoprazole	15MG/PACKET	FOR SUSPENSION, DELAYED RELEASE;ORAL	Discontinued	None	No	No
MESH:D009207	prevacid	lansoprazole	15MG	TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL	Prescription	None	Yes	No
MESH:D009207	daytrana	methylphenidate	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	Yes	No
MESH:D009207	daytrana	methylphenidate	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	Yes	No
MESH:D009207	daytrana	methylphenidate	10MG/9HR (1.1MG/HR)	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	Yes	No
MESH:D009207	zyprexa	olanzapine	2.5MG	TABLET;ORAL	Prescription	AB	Yes	No
MESH:D009207	zyprexa	olanzapine	2.5MG	TABLET;ORAL	Prescription	AB	Yes	No
MESH:D009207	zyprexa	olanzapine	10MG/VIAL	INJECTABLE;INTRAMUSCULAR	Prescription	AP	Yes	Yes
MESH:D009207	zyprexa	olanzapine	10MG/VIAL	INJECTABLE;INTRAMUSCULAR	Prescription	AP	Yes	Yes
MESH:D009207	zyprexa	olanzapine	2.5MG	TABLET;ORAL	Prescription	AB	Yes	No
MESH:D009207	zyprexa	olanzapine	2.5MG	TABLET;ORAL	Prescription	AB	Yes	No
MESH:D009207	zyprexa	olanzapine	10MG/VIAL	INJECTABLE;INTRAMUSCULAR	Prescription	AP	Yes	Yes
MESH:D009207	zyprexa	olanzapine	10MG/VIAL	INJECTABLE;INTRAMUSCULAR	Prescription	AP	Yes	Yes
MESH:D009207	topamax	topiramate	100MG	TABLET;ORAL	Prescription	AB	Yes	Yes
MESH:D009207	topamax	topiramate	15MG	CAPSULE;ORAL	Prescription	AB	Yes	No
MESH:D009207	topamax	topiramate	100MG	TABLET;ORAL	Prescription	AB	Yes	Yes
MESH:D009207	topamax	topiramate	15MG	CAPSULE;ORAL	Prescription	AB	Yes	No
MESH:D009207	topamax	topiramate	100MG	TABLET;ORAL	Prescription	AB	Yes	Yes
MESH:D009207	topamax	topiramate	15MG	CAPSULE;ORAL	Prescription	AB	Yes	No
MESH:D009207	topamax	topiramate	100MG	TABLET;ORAL	Prescription	AB	Yes	Yes
MESH:D009207	topamax	topiramate	15MG	CAPSULE;ORAL	Prescription	AB	Yes	No
MESH:D009207	ofirmev	acetaminophen	1GM/100ML (10MG/ML)	SOLUTION;IV (INFUSION)	Prescription	AP	Yes	Yes
MESH:D009207	ofirmev	acetaminophen	1GM/100ML (10MG/ML)	SOLUTION;IV (INFUSION)	Prescription	AP	Yes	Yes
MESH:D009207	acetaminophen	acetaminophen	650MG	SUPPOSITORY;RECTAL	Over-the-counter	None	Yes	Yes
MESH:D009207	acetaminophen	acetaminophen	650MG	SUPPOSITORY;RECTAL	Over-the-counter	None	Yes	Yes
MESH:D009207	lysteda	tranexamic acid	650MG	TABLET;ORAL	Prescription	AB	Yes	Yes
MESH:D009207	sabril	vigabatrin	500MG	TABLET;ORAL	Prescription	None	Yes	Yes
MESH:D009207	sabril	vigabatrin	500MG/PACKET	FOR SOLUTION;ORAL	Prescription	AA	Yes	Yes

FDA labeling changes(Total Drugs:47)
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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	01/13/2003	busulfex	busulfan	Part of a conditioning regimen administered prior to hematopoietic progenitor cell transplantation for a variety of malignant hematologic or non-malignant diseases	The population pharmacokinetic estimates of busulfan for clearance and volume of distribution were determined in an open-label, uncontrolled PK study in 24 pediatric patients 5 months to 16 years who received busulfan as part of a conditioning regimen administered prior to hematopoietic progenitor cell transplantation for a variety of malignant hematologic or non-malignant diseases Suggested dosing regimen	Labeling	B	-	-	-	Orphan Medical	12/3/2002	FALSE'
MESH:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	06/17/2004	prevacid	lansoprazole	Short-term treatment of symptomatic GERD and erosive Esophagitis	Expanded age range to include patients 12 -17 years of age; previously labeled only in pediatric patients 1-11 years of age Safety and effectiveness in pediatric patients	Labeling	B	-	-	-	Tap	07/15/2008	FALSE'
MESH:D009207	06/17/2004	prevacid	lansoprazole	Short-term treatment of symptomatic GERD and erosive Esophagitis	Expanded age range to include patients 12 -17 years of age; previously labeled only in pediatric patients 1-11 years of age Safety and effectiveness in pediatric patients	Labeling	B	-	-	-	Tap	07/15/2008	FALSE'
MESH:D009207	06/17/2004	prevacid	lansoprazole	Short-term treatment of symptomatic GERD and erosive Esophagitis	Expanded age range to include patients 12 -17 years of age; previously labeled only in pediatric patients 1-11 years of age Safety and effectiveness in pediatric patients	Labeling	B	-	-	-	Tap	07/15/2008	FALSE'
MESH:D009207	10/28/2008	prevacid	lansoprazole	Symptomatic GERD in infants	Effectiveness was not established in a 4 week multicenter, double-blind, placebo-controlled study of patients 1 month and < 12 months of age AE profile similar to that observed in adultsInformation on PK parameters in neonates to < 1 year, and clinical studies	Labeling	-	-	B, P	-	Takeda	07/15/2008	FALSE'
MESH:D009207	10/28/2008	prevacid	lansoprazole	Symptomatic GERD in infants	Effectiveness was not established in a 4 week multicenter, double-blind, placebo-controlled study of patients 1 month and < 12 months of age AE profile similar to that observed in adultsInformation on PK parameters in neonates to < 1 year, and clinical studies	Labeling	-	-	B, P	-	Takeda	07/15/2008	FALSE'
MESH:D009207	10/28/2008	prevacid	lansoprazole	Symptomatic GERD in infants	Effectiveness was not established in a 4 week multicenter, double-blind, placebo-controlled study of patients 1 month and < 12 months of age AE profile similar to that observed in adultsInformation on PK parameters in neonates to < 1 year, and clinical studies	Labeling	-	-	B, P	-	Takeda	07/15/2008	FALSE'
MESH:D009207	6/4/2006	daytrana	methylphenidate	ADHD	Summary is pending	Labeling	-	P	-	-	Shire	-	FALSE'
MESH:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	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:D009207	08/21/2013	lysteda	tranexamic acid	Treatment of cyclic heavy menstrual bleeding	Indicated for women of reproductive age. It is not intended for use in premenarcheal girls Information on PK studyPostmarketing study	-	P	-	-	Ferring	-	FALSE'	-
MESH:D009207	10/26/2013	sabril	vigabatrin	Refractory complex partial seizures (rCPS)	Approved as adjunctive therapy for pediatric patients 10 years and older with rCPS for whom the potential benefits outweigh the risk of vision loss. Sabril is not a first line agent for rCPS Safety and effectiveness for pediatric patients less than 10 years with refractory rCPS have not been established Pooled data from 3 controlled trials in pediatric patients demonstrated that 6% (10/165) of Sabril patients experienced somnolence compared to 5% (5/104) of placebo patients. In those same studies, 10% (17/165) of Sabril patients experienced fatigue compared to 7% (7/104) of placebo patients; 47% (77/163) of Sabril patients versus 19% (19/102) of placebo patients gained greater than or equal to 7% of baseline body weight Adverse reactions (ARs) in the pediatric population were similar to those reported in adults. Overall, ARs in pediatric patients 10-16 years included increased weight, upper respiratory tract infection, tremor, fatigue, aggression and diplopia Information on weight based dosing, dosing in renal impairment, safety information and clinical trials	Labeling	-	-	B,P	-	Lundbeck LLC	3/10/2013	FALSE'
MESH:D009207	10/26/2013	sabril	vigabatrin	Refractory complex partial seizures (rCPS)	Approved as adjunctive therapy for pediatric patients 10 years and older with rCPS for whom the potential benefits outweigh the risk of vision loss. Sabril is not a first line agent for rCPS Safety and effectiveness for pediatric patients less than 10 years with refractory rCPS have not been established Pooled data from 3 controlled trials in pediatric patients demonstrated that 6% (10/165) of Sabril patients experienced somnolence compared to 5% (5/104) of placebo patients. In those same studies, 10% (17/165) of Sabril patients experienced fatigue compared to 7% (7/104) of placebo patients; 47% (77/163) of Sabril patients versus 19% (19/102) of placebo patients gained greater than or equal to 7% of baseline body weight Adverse reactions (ARs) in the pediatric population were similar to those reported in adults. Overall, ARs in pediatric patients 10-16 years included increased weight, upper respiratory tract infection, tremor, fatigue, aggression and diplopia Information on weight based dosing, dosing in renal impairment, safety information and clinical trials	Labeling	-	-	B,P	-	Lundbeck LLC	3/10/2013	FALSE'