Last reviewed: June 2018
Last updated: June  2018

European Medicines Agency (EMA) strengthens measures to avoid use of valproate medicines in pregnancy

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 program 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

  • Counseling 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.

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Original source of update

Summary

Definition

History and exam

Key diagnostic factors

  • ≥2-year period of seasonally related changes in mood
  • fall or winter depression
  • spring or summer symptom remission
  • atypical depressive symptoms
  • vegetative depressive symptoms
  • spring or summer manic or hypomanic symptoms
  • spring or summer depression
  • manic/hypomanic symptoms

Other diagnostic factors

  • somatic symptoms
  • behavioral withdrawal
  • functional impairments
  • excessive alcohol use
  • tachycardia
  • increased systolic blood pressure
  • restlessness

Risk factors

  • exposure to diminished light during winter and increased light during summer
  • residing at a northern latitude
  • family history of SAD
  • female gender
  • age 20 to 30 years
  • psychological factors (e.g., high neuroticism)
  • psychiatric comorbidity (e.g., anxiety, ADHD, premenstrual dysphoric disorders)
  • alcohol use

Diagnostic investigations

Investigations to consider

  • blood metabolic panel
  • serum thyroid-stimulating hormone
  • toxicology screen (urine and blood)
Full details

Treatment algorithm

Contributors

Authors VIEW ALL

Craig N. Sawchuk

Associate Professor

Co-Chair, Division of Integrated Behavioral Health

Department of Psychiatry and Psychology

Mayo Clinic

Rochester

MN

Disclosures

CNS declares that he has no competing interests.

Jason P. Veitengruber

Assistant Professor

Department of Psychiatry and Behavioral Sciences

University of Washington School of Medicine

Seattle

WA

Disclosures

JPV declares that he has no competing interests.

Clinical Instructor

Department of Psychiatry and Psychology

Mayo Clinic

Rochester

MN

Disclosures

WBL declares that he has no competing interests.

Peer reviewers VIEW ALL

Director of Assessment

Office of Curriculum and Assessment

University of Rochester School of Medicine and Dentistry

Rochester

NY

Disclosures

SL declares that he has no competing interests.

Department of Psychiatry and Psychotherapy

Medical University of Vienna

Vienna

Austria

Disclosures

DW is an author of a number of references cited in this topic. DW declares that he has no competing interests.

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