To the Editor
We read with great interest the article by S. Thippaiah and colleagues in a recent issue of the journal.1 The authors reported the interesting case of a 19-year-old woman who presented with cyclical changes in mood and behavior, alternating between depression and mania, and a correlation with her menstrual cycle was made.
Despite the fact that the menstrual psychoses have been described for two centuries, the knowledge and familiarity about the disorder remain poor, leading to inaccurate diagnoses and suboptimal treatment and prognosis. The authors should be congratulated for identifying this correlation of the patient’s symptoms and her hormonal cycles and raising awareness for such an important entity that often goes undetected.
Although the case report is absolutely relevant and informative, there is a crucial point that we would like to address, i.e., the choice of valproic acid as the mood stabilizer for a 19-year old woman. In women of reproductive age, valproic acid should perhaps be among the last options to be considered given its teratogenic potential and neurocognitive effects in the developing fetus. When alternative drugs are not an option, the clinician must extensively review and discuss the risks with the patient and concurrently offer contraception and start her on 4 mg of folic acid to reduce those risks.2 Careful documentation about that discussion, with an individual risk/benefit analysis, should be made.
This approach has been endorsed by several organizations: in 2009, the American Academy of Neurology and the American Epilepsy Society recommended against the use of valproic acid in women of childbearing age,3 a decision that was followed in 2014 by the European Medicine Agency (EMA)’s Pharmacovigilance and Risk Assessment Committee; last summer, the French National Agency for the Safety of Medicines and Health Products (ANSM) issued a ban4 on the use of valproate by women of childbearing age with bipolar disorder if there is no efficient contraceptive method in place, and approximately 30 other European countries are expected to implement similar regulations. In the UK, the National institute for Health and Care Excellence (NICE) recently issued a new regulatory position5 for valproate stating it may no longer be prescribed to women or girls of childbearing potential unless they are on the pregnancy prevention programme (PPP).
This long-standing concern is based on numerous studies, including one by French National Health Insurance Information System with 2323 mothers who used valproic acid during pregnancy and found that the risk for major malformations in children born to women treated with valproic acid for was 46.5/1000 compared to 10.2/1000 in the general population.6 It is believed that the risk for a major malformation is even higher (twofold) for women with bipolar disorder, which is the case on this report.
We would like to emphasize these issues as they were not discussed by the authors and may be help guide the psychotropic choice for women of reproductive age.
Footnotes
Conflicts of Interest
The authors have no conflict of interest.
References
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