In March 2018 the EMA announced stronger measures aimed at avoiding the exposure of babies to valproate medicines in the womb. Under the new restrictions, valproate medicines are contraindicated in bipolar disorder during pregnancy due to the high risk of congenital malformations and developmental problems in the child.
Valproate medicines must not be used in female patients of childbearing potential unless there is a pregnancy prevention programme in place and certain conditions are met. These include:
an assessment of the patient’s potential for becoming pregnant
pregnancy tests before starting and during treatment as needed
counselling about the risks of valproate treatment and the need for effective contraception throughout treatment
a review of ongoing treatment by a specialist at least annually
a risk acknowledgement form that patients and prescribers will go through at each such annual review to confirm that appropriate advice has been given and understood.
The EMA said the new measures were put in place because of evidence suggesting that information on the risks of valproate use in pregnancy was still not getting through to women despite earlier steps aimed at ensuring this.See Management: approach See Management: treatment algorithm
A recurrent and sometimes chronic mental illness marked by alternating periods of abnormal mood elevation and depression associated with a change or impairment in functioning.
The long-term course of illness is characterised by a predominance of depression, although a history of at least one manic, hypomanic, or mixed episode is required to make the diagnosis of a bipolar disorder.
Diagnosis is based on interviews with the patient and family, using diagnostic criteria for bipolar disorder.
Misdiagnosis of bipolar disorder is common, with unipolar major depressive disorder the most frequent diagnostic error made.
The management of acute mania requires the use of mood stabilisers or atypical antipsychotics, as monotherapy or in combination. There are fewer approved treatment options for acute bipolar depression; traditional antidepressants are not indicated.
Bipolar disorder requires individualising a long-term management plan that includes maintenance medication(s), adjunctive psychosocial therapies, and careful monitoring for any treatment-emergent complications.
Bipolar disorder, previously termed manic depression, is a psychiatric diagnosis characterised by abnormally elevated or irritable mood episode(s) accompanied by disruptive symptoms of distractibility, indiscretions, grandiosity, flight of ideas, hyperactivity, decreased need for sleep, and talkativeness.  Manic episodes include a clustering of these symptoms over at least a period of 1 week, and are more disruptive than hypomania (milder symptoms, >4 days' duration). It is marked by alternating mood elevation (mania or hypomania) and depression.
Assistant Professor of Psychiatry
University of Texas Health Science Center
SS has received intravenous citalopram for research from Lundbeck UK and participated as a speaker organised by Global Medical Education. SS has third-party indirect share in the form of convertible note in Flow MedTech, Inc (a medical device start-up company).
Dr Sudhakar Selvaraj would like to gratefully acknowledge Dr Prashant Gajwani and Dr David J. Muzina, previous contributors to this topic. PG has served on the speakers' bureau for Merck and Sunovion. DJM is an author of a number of references cited in this topic. DJM has previously received honoraria for research support from Repligen Co. He has also previously received honoraria as a speaker and/or advisor from AstraZeneca, Pfizer, BMS, Wyeth, Sepracor, and GSK. DJM is a full-time employee of Medco.
Mood Disorders Psychopharmacology Unit
University Health Network
Associate Professor of Psychiatry and Pharmacology
University of Toronto
RM has received research funds from Stanley Medical Research Institute and National Alliance for Research on Schizophrenia and Depression (NARSAD). RM is on the advisory boards for AstraZeneca, Bristol-Myers Squibb, France Foundation, GlaxoSmithKline Janssen-Ortho, Solvay/Wyeth, Eli Lilly, Organon, Lundbeck, Biovail, Pfizer, Shire, and Schering-Plough. RM is on the speakers' bureau for Janssen-Ortho, AstraZeneca, Eli Lilly, Lundbeck, Biovail, and Wyeth. RM has received research grants from Eli Lilly, Janssen-Ortho, and Shire.
Professor of Psychological Medicine
University of Newcastle
Psychological Treatments Research
Institute of Psychiatry
University Department of Psychiatry
Royal Victoria Infirmary
Newcastle upon Tyne
JS has received remuneration for attending advisory boards for AstraZeneca, BSM-Otsuka, Eli Lilly, GSK, and Sanofi-Aventis.
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