As more hospitals and clinics adopt ketamine therapy for treating severe depression, post-traumatic stress disorder (PTSD), and other mental health conditions that have proven resistant to traditional treatments, a new study raises concerns about the inconsistent practices related to pregnancy and contraception among these facilities.
While ketamine is deemed safe under medical supervision, it poses significant risks to a developing fetus and is contraindicated during pregnancy. However, researchers from the University of Michigan’s Michigan Medicine have found that many ketamine prescribers are not adequately addressing these risks. Their findings suggest a pressing need for clinics to ensure that patients receiving ketamine therapy are not pregnant and are informed about the necessity of using contraception throughout their treatment, which may extend over several months.
The study, published in the Journal of Clinical Psychiatry, involved a nationwide survey and document review of ketamine clinics, as well as an analysis of records from the U-M Health ketamine clinic for depression. The results revealed a troubling variability in policies and practices regarding ketamine use in relation to pregnancy and reproductive health.
These findings are particularly concerning given that over 80% of clinics prescribe long-term maintenance ketamine, with nearly 70% reporting that patients receive treatment for six months or longer.
A review of records from 24 patients treated at U-M’s clinic revealed that while all had undergone pregnancy testing prior to and during treatment, only half had documented evidence of contraception use.
Lead author Dr. Rachel Pacilio, a psychiatrist at Michigan Medicine, was inspired to conduct this study during her rotation in a perinatal psychiatry clinic, where she encountered patients who were either pregnant or recently postpartum and inquiring about ketamine for treatment-resistant depression. The lack of clear guidance for prescribers regarding the use of ketamine in pregnant patients prompted her to investigate how clinics manage these risks.
The study highlights significant differences in oversight among clinics. Intravenous ketamine administration requires specialized staff and monitoring, as mandated by the FDA, while other forms of ketamine can be prescribed for at-home use with minimal supervision. The study did not include online ketamine providers that operate through telehealth, leaving a gap in understanding how these services address reproductive safety concerns.
Dr. Pacilio emphasized the risk that patients could become pregnant while undergoing ketamine treatment, especially considering that many individuals may not realize they are pregnant in the early weeks. She noted that while some psychotropic medications have been studied extensively for safety during pregnancy, there is no data supporting the use of ketamine in this context.
Following the study’s findings, the U-M Health ketamine clinic began recommending reliable contraception methods for patients who could potentially become pregnant during treatment. The authors argue that standardized guidelines for reproductive counseling, pregnancy testing, and contraception recommendations are essential, particularly for smaller clinics that may lack the resources of larger institutions.
Dr. Pacilio stated, “Ketamine is a highly effective, potentially lifesaving treatment for the right patients, but it is crucial that it is administered in a manner that maximizes benefits while minimizing risks.”
In a related commentary, psychiatrist and journal editor Dr. Marlene Freeman emphasized the urgent need to establish best practices for the use of ketamine and esketamine in women of reproductive age, especially in light of evolving abortion-related laws. She also encouraged those who have used ketamine during pregnancy to participate in the National Pregnancy Registry for Psychiatric Medications to help gather important data on the effects of these medications.
The study was funded by the University of Michigan Department of Psychiatry and includes contributions from several faculty members and fellows at Michigan Medicine.
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