Editing Valproate (section)

===Approval status===
{{update section|date=February 2024}}
{| class = wikitable
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! Indications
! {{flagicon|USA}}<br />[[Food and Drug Administration|FDA]]-labelled indication?<ref name = MSR/>
! {{flagicon|AUS}}<br />[[Therapeutic Goods Administration|TGA]]-labelled indication?<ref name = AMH>{{cite book | title = Australian Medicines Handbook | year = 2013 | publisher = The Australian Medicines Handbook Unit Trust | isbn = 978-0-9805790-9-3 | edition = 2013 | place = Adelaide | editor = Rossi, S }}</ref>
! scope="col" |{{flagicon|GBR}}<br />[[Medicines and Healthcare products Regulatory Agency|MHRA]]-labelled indication?<ref name = BNF>{{cite book | author = Joint Formulary Committee | title = British National Formulary (BNF) | isbn = 978-0-85711-084-8 | edition = 65 | location = London, UK | publisher = Pharmaceutical Press | year = 2013 | url-access = registration | url = https://archive.org/details/bnf65britishnati0000unse }}</ref>
! Literature support
|-
| Epilepsy || {{yes}} || {{yes}} || {{yes}} || Limited (depends on the seizure type; it can help with certain kinds of seizures: drug-resistant epilepsy, partial and absence seizures, can be used against [[glioblastoma]] and other tumors both to improve survival and treat seizures, and against [[tonic–clonic seizures]] and status epilepticus).<ref>{{cite journal | vauthors = Rimmer EM, Richens A | title = An update on sodium valproate | journal = Pharmacotherapy | volume = 5 | issue = 3 | pages = 171–184 | date = May–June 1985 | pmid = 3927267 | doi = 10.1002/j.1875-9114.1985.tb03413.x | s2cid = 7700266 }}</ref><ref>{{cite journal | vauthors = Glauser TA, Cnaan A, Shinnar S, Hirtz DG, Dlugos D, Masur D, Clark PO, Capparelli EV, Adamson PC | title = Ethosuximide, valproic acid, and lamotrigine in childhood absence epilepsy | journal = The New England Journal of Medicine | volume = 362 | issue = 9 | pages = 790–799 | date = March 2010 | pmid = 20200383 | pmc = 2924476 | doi = 10.1056/NEJMoa0902014 }}</ref><ref>{{cite journal|url=http://www.neurology.org/content/84/14_Supplement/P1.238|title=Co-Administration of Valproic Acid and Lamotrigine in the Treatment of Refractory Epilepsy (P1.238)|vauthors=Jiang M|date=6 April 2015|journal=Neurology|volume=84|issue=14 Supplement|pages=P1.238|doi=10.1212/WNL.84.14_supplement.P1.238|s2cid=74543829|via=www.neurology.org|access-date=4 May 2015|archive-date=27 August 2021|archive-url=https://web.archive.org/web/20210827175359/https://n.neurology.org/content/84/14_Supplement/P1.238|url-status=live|url-access=subscription}}</ref><ref>{{cite journal| vauthors = Berendsen S, Kroonen J, Seute T, Snijders T, Broekman ML, Spliet WG, Artesi M, Bours V, Robe PA  |title= O9.06 * Prognostic Relevance and Oncogenic Correlates of Epilepsy in Glioblastoma Patients |date=1 September 2014|journal=Neuro-Oncology|volume=16|issue=suppl_2|pages=ii21|doi=10.1093/neuonc/nou174.77|pmc=4185847}}</ref>
|-
| Bipolar mania || {{yes}} || {{yes}} || {{yes}} || Limited.<ref>{{cite journal | vauthors = Vasudev K, Mead A, Macritchie K, Young AH | title = Valproate in acute mania: is our practice evidence based? | journal = International Journal of Health Care Quality Assurance | volume = 25 | issue = 1 | pages = 41–52 | year = 2012 | pmid = 22455007 | doi = 10.1108/09526861211192395 }}</ref>{{Failed verification|date=November 2023|reason=Cited source contains "Design/methodology/approach: Case notes from 43 (42 percent male) patients" which does not support the claim that there is limited literature support.}}
|-
| Bipolar depression || {{no}} || {{no}} || {{no}} || Moderate.<ref>{{cite journal | vauthors = Bond DJ, Lam RW, Yatham LN | title = Divalproex sodium versus placebo in the treatment of acute bipolar depression: a systematic review and meta-analysis | journal = Journal of Affective Disorders | volume = 124 | issue = 3 | pages = 228–234 | date = August 2010 | pmid = 20044142 | doi = 10.1016/j.jad.2009.11.008 }}</ref>
|-
| Bipolar maintenance || {{no}} || {{no}} || {{no}} || Limited.<ref>{{cite journal | vauthors = Haddad PM, Das A, Ashfaq M, Wieck A | title = A review of valproate in psychiatric practice | journal = Expert Opinion on Drug Metabolism & Toxicology | volume = 5 | issue = 5 | pages = 539–551 | date = May 2009 | pmid = 19409030 | doi = 10.1517/17425250902911455 | s2cid = 74028228 }}</ref>
|-
| Migraine prophylaxis || {{yes}} || {{Yes}} (accepted) || {{no}} || Limited.
|-
| Acute migraine management || {{no}} || {{no}} || {{no}} || Only negative results.<ref>{{cite journal | vauthors = Frazee LA, Foraker KC | title = Use of intravenous valproic acid for acute migraine | journal = The Annals of Pharmacotherapy | volume = 42 | issue = 3 | pages = 403–407 | date = March 2008 | pmid = 18303140 | doi = 10.1345/aph.1K531 | s2cid = 207263036 }}</ref>
|-
| Schizophrenia || {{no}} || {{no}} || {{no}} || Weak evidence.<ref>{{cite journal | vauthors = Wang Y, Xia J, Helfer B, Li C, Leucht S | title = Valproate for schizophrenia | journal = The Cochrane Database of Systematic Reviews | volume = 2016 | issue = 11 | pages = CD004028 | date = November 2016 | pmid = 27884042 | pmc = 6734130 | doi = 10.1002/14651858.CD004028.pub4 }}</ref>

|-
| Agitation in dementia || {{no}} || {{no}} || {{no}} || Weak evidence. Not recommended for agitation in people with dementia.<ref name=":2">{{cite journal | vauthors = Baillon SF, Narayana U, Luxenberg JS, Clifton AV | title = Valproate preparations for agitation in dementia | journal = The Cochrane Database of Systematic Reviews | volume = 2018 | issue = 10 | pages = CD003945 | date = October 2018 | pmid = 30293233 | pmc = 6516950 | doi = 10.1002/14651858.CD003945.pub4 }}</ref> Increased rate of adverse effects, including a risk of serious adverse effects.<ref name=":2" />
|-
| [[Fragile X syndrome]] || {{yes}} (orphan) || {{no}} || {{no}} || Limited.<ref name="Therapeutic potential of mood stabi"/>
|-
| [[Familial adenomatous polyposis]] || {{yes}} (orphan) || {{no}} || {{no}} || Limited.
|-
| Chronic pain & fibromyalgia || {{no}} || {{no}} || {{no}} || Limited.<ref>{{cite journal | vauthors = Gill D, Derry S, Wiffen PJ, Moore RA | title = Valproic acid and sodium valproate for neuropathic pain and fibromyalgia in adults | journal = The Cochrane Database of Systematic Reviews | volume = 2011 | issue = 10 | pages = CD009183 | date = October 2011 | pmid = 21975791 | pmc = 6540387 | doi = 10.1002/14651858.CD009183.pub2 }}</ref>
|-
| Alcohol hallucinosis || {{no}} || {{no}} || {{no}} || One randomised double-blind placebo-controlled trial.<ref>{{cite journal | vauthors = Aliyev ZN, Aliyev NA | title = Valproate treatment of acute alcohol hallucinosis: a double-blind, placebo-controlled study | journal = Alcohol and Alcoholism | volume = 43 | issue = 4 | pages = 456–459 | date = July–August 2008 | pmid = 18495806 | doi = 10.1093/alcalc/agn043 | doi-access = free }}</ref>
|-
| Intractable hiccups || {{no}} || {{no}} || {{no}} || Limited, five case reports support its efficacy, however.<ref>{{cite journal | vauthors = Jacobson PL, Messenheimer JA, Farmer TW | title = Treatment of intractable hiccups with valproic acid | journal = Neurology | volume = 31 | issue = 11 | pages = 1458–1460 | date = November 1981 | pmid = 6796902 | doi = 10.1212/WNL.31.11.1458 | s2cid = 1578958 }}</ref>
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| Non-epileptic myoclonus || {{no}} || {{no}} || {{no}} || Limited, three case reports support its efficacy, however.<ref>{{cite journal | vauthors = Sotaniemi K | title = Valproic acid in the treatment of nonepileptic myoclonus | journal = Archives of Neurology | volume = 39 | issue = 7 | pages = 448–449 | date = July 1982 | pmid = 6808975 | doi = 10.1001/archneur.1982.00510190066025 }}</ref>
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| Cluster headaches || {{no}} || {{no}} || {{no}} || Limited, two case reports support its efficacy.<ref>{{cite journal | vauthors = Wheeler SD | title = Significance of migrainous features in cluster headache: divalproex responsiveness | journal = Headache | volume = 38 | issue = 7 | pages = 547–551 | date = July–August 1998 | pmid = 15613172 | doi = 10.1046/j.1526-4610.1998.3807547.x | s2cid = 27948702 | doi-access = free }}</ref>
|-
| [[West syndrome]] || {{no}} || {{no}} || {{no}} || A prospective clinical trial supported its efficacy in treating infantile spasms.<ref>{{cite journal | vauthors = Siemes H, Spohr HL, Michael T, Nau H | title = Therapy of infantile spasms with valproate: results of a prospective study | journal = Epilepsia | volume = 29 | issue = 5 | pages = 553–560 | date = September–October 1988 | pmid = 2842127 | doi = 10.1111/j.1528-1157.1988.tb03760.x | s2cid = 23789333 }}</ref>
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| HIV infection eradication || {{no}} || {{no}} || {{no}} || Double-blind placebo-controlled trials have been negative.<ref>{{cite journal | vauthors = Smith SM | title = Valproic acid and HIV-1 latency: beyond the sound bite | journal = Retrovirology | volume = 2 | issue = 1 | pages = 56 | date = September 2005 | pmid = 16168066 | pmc = 1242254 | doi = 10.1186/1742-4690-2-56 | doi-access = free }}</ref><ref>{{cite journal | vauthors = Routy JP, Tremblay CL, Angel JB, Trottier B, Rouleau D, Baril JG, Harris M, Trottier S, Singer J, Chomont N, Sékaly RP, Boulassel MR | title = Valproic acid in association with highly active antiretroviral therapy for reducing systemic HIV-1 reservoirs: results from a multicentre randomized clinical study | journal = HIV Medicine | volume = 13 | issue = 5 | pages = 291–296 | date = May 2012 | pmid = 22276680 | doi = 10.1111/j.1468-1293.2011.00975.x | s2cid = 27571864 | doi-access = free }}</ref><ref>{{cite journal | vauthors = Archin NM, Cheema M, Parker D, Wiegand A, Bosch RJ, Coffin JM, Eron J, Cohen M, Margolis DM | title = Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection | journal = PLOS ONE | volume = 5 | issue = 2 | pages = e9390 | date = February 2010 | pmid = 20186346 | pmc = 2826423 | doi = 10.1371/journal.pone.0009390 | doi-access = free | bibcode = 2010PLoSO...5.9390A }}</ref>
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| [[Myelodysplastic syndrome]] || {{no}} || {{no}} || {{no}} || Several clinical trials have confirmed its efficacy as a monotherapy,<ref name = m2001>{{cite journal | vauthors = Hardy JR, Rees EA, Gwilliam B, Ling J, Broadley K, A'Hern R | title = A phase II study to establish the efficacy and toxicity of sodium valproate in patients with cancer-related neuropathic pain | journal = Journal of Pain and Symptom Management | volume = 21 | issue = 3 | pages = 204–209 | date = March 2001 | pmid = 11239739 | doi = 10.1016/S0885-3924(00)00266-9 | doi-access = free }}{{Dead link|date=October 2019 |bot=InternetArchiveBot |fix-attempted=yes }}</ref> as an adjunct to [[tretinoin]]<ref name = m2001/> and as an adjunct to hydralazine.<ref>{{cite journal | vauthors = Candelaria M, Herrera A, Labardini J, González-Fierro A, Trejo-Becerril C, Taja-Chayeb L, Pérez-Cárdenas E, de la Cruz-Hernández E, Arias-Bofill D, Vidal S, Cervera E, Dueñas-Gonzalez A | title = Hydralazine and magnesium valproate as epigenetic treatment for myelodysplastic syndrome. Preliminary results of a phase-II trial | journal = Annals of Hematology | volume = 90 | issue = 4 | pages = 379–387 | date = April 2011 | pmid = 20922525 | doi = 10.1007/s00277-010-1090-2 | s2cid = 13437134 }}</ref>
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| [[Acute myeloid leukaemia]] || {{no}} || {{no}} || {{no}} || Two clinical trials have confirmed its efficacy in this indication as both a monotherapy and as an adjunct to [[tretinoin]].<ref>{{cite journal | vauthors = Bug G, Ritter M, Wassmann B, Schoch C, Heinzel T, Schwarz K, Romanski A, Kramer OH, Kampfmann M, Hoelzer D, Neubauer A, Ruthardt M, Ottmann OG | title = Clinical trial of valproic acid and all-trans retinoic acid in patients with poor-risk acute myeloid leukemia | journal = Cancer | volume = 104 | issue = 12 | pages = 2717–2725 | date = December 2005 | pmid = 16294345 | doi = 10.1002/cncr.21589 | s2cid = 1802132 }}</ref><ref>{{cite journal | vauthors = Kuendgen A, Schmid M, Schlenk R, Knipp S, Hildebrandt B, Steidl C, Germing U, Haas R, Dohner H, Gattermann N | title = The histone deacetylase (HDAC) inhibitor valproic acid as monotherapy or in combination with all-trans retinoic acid in patients with acute myeloid leukemia | journal = Cancer | volume = 106 | issue = 1 | pages = 112–119 | date = January 2006 | pmid = 16323176 | doi = 10.1002/cncr.21552 | s2cid = 43747497 | doi-access = free }}</ref><ref>{{cite journal | vauthors = Fredly H, Gjertsen BT, Bruserud O | title = Histone deacetylase inhibition in the treatment of acute myeloid leukemia: the effects of valproic acid on leukemic cells, and the clinical and experimental evidence for combining valproic acid with other antileukemic agents | journal = Clinical Epigenetics | volume = 5 | issue = 1 | pages = 12 | date = July 2013 | pmid = 23898968 | pmc = 3733883 | doi = 10.1186/1868-7083-5-12 | doi-access = free }}</ref>
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| [[Cervical cancer]] || {{no}} || {{no}} || {{no}} || One clinical trial supports its use here.<ref>{{cite journal | vauthors = Coronel J, Cetina L, Pacheco I, Trejo-Becerril C, González-Fierro A, de la Cruz-Hernandez E, Perez-Cardenas E, Taja-Chayeb L, Arias-Bofill D, Candelaria M, Vidal S, Dueñas-González A | title = A double-blind, placebo-controlled, randomized phase III trial of chemotherapy plus epigenetic therapy with hydralazine valproate for advanced cervical cancer. Preliminary results | journal = Medical Oncology | volume = 28 | issue = Suppl 1 | pages = S540–S546 | date = December 2011 | pmid = 20931299 | doi = 10.1007/s12032-010-9700-3 | s2cid = 207372333 }}</ref>
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| [[Malignant melanoma]] || {{no}} || {{no}} || {{no}} || One phase II study has seemed to discount its efficacy.<ref>{{cite journal | vauthors = Rocca A, Minucci S, Tosti G, Croci D, Contegno F, Ballarini M, Nolè F, Munzone E, Salmaggi A, Goldhirsch A, Pelicci PG, Testori A | title = A phase I-II study of the histone deacetylase inhibitor valproic acid plus chemoimmunotherapy in patients with advanced melanoma | journal = British Journal of Cancer | volume = 100 | issue = 1 | pages = 28–36 | date = January 2009 | pmid = 19127265 | pmc = 2634690 | doi = 10.1038/sj.bjc.6604817 }}</ref>
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| [[Breast cancer]] || {{no}} || {{no}} || {{no}} || A phase II study has supported its efficacy.<ref>{{cite journal | vauthors = Munster P, Marchion D, Bicaku E, Lacevic M, Kim J, Centeno B, Daud A, Neuger A, Minton S, Sullivan D | title = Clinical and biological effects of valproic acid as a histone deacetylase inhibitor on tumor and surrogate tissues: phase I/II trial of valproic acid and epirubicin/FEC | journal = Clinical Cancer Research | volume = 15 | issue = 7 | pages = 2488–2496 | date = April 2009 | pmid = 19318486 | doi = 10.1158/1078-0432.CCR-08-1930 | s2cid = 3230087 }}</ref>
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| [[Impulse control disorder]] || {{no}} || {{no}} || {{no}} || Limited.<ref name=Hicks>{{cite journal | vauthors = Hicks CW, Pandya MM, Itin I, Fernandez HH | title = Valproate for the treatment of medication-induced impulse-control disorders in three patients with Parkinson's disease | journal = Parkinsonism & Related Disorders | volume = 17 | issue = 5 | pages = 379–381 | date = June 2011 | pmid = 21459656 | doi = 10.1016/j.parkreldis.2011.03.003 }}</ref><ref>{{cite journal | vauthors = Sriram A, Ward HE, Hassan A, Iyer S, Foote KD, Rodriguez RL, McFarland NR, Okun MS | title = Valproate as a treatment for dopamine dysregulation syndrome (DDS) in Parkinson's disease | journal = Journal of Neurology | volume = 260 | issue = 2 | pages = 521–527 | date = February 2013 | pmid = 23007193 | doi = 10.1007/s00415-012-6669-1 | s2cid = 21544457 }}</ref>
|}