With the increasing use of ketamine for treating depression and PTSD, there are concerns regarding its effects on pregnancy. A recent study highlights significant discrepancies in how clinics approach pregnancy testing and contraception advice for patients receiving ketamine treatments.
The availability of ketamine therapy is expanding in hospitals and clinics for treating severe depression, PTSD, and other mental health disorders that have not improved with other therapies.
Although ketamine is generally safe when administered under medical supervision, it carries a little-known risk: it can be very detrimental to a fetus. Therefore, it’s not meant for use during pregnancy.
However, a new study indicates that those prescribing ketamine may not sufficiently acknowledge this risk. There is a need for better screening to ensure that women receiving ketamine are not pregnant and are informed about the importance of using birth control throughout their treatment, which might last several months.
This study, published in the Journal of Clinical Psychiatry, involved researchers from Michigan Medicine, part of the University of Michigan’s academic medical center. They conducted surveys and reviewed documents from ketamine clinics across the country, including the depression ketamine clinic at U-M Health.
The findings reveal a considerable inconsistency in the policies and communications regarding ketamine treatment in relation to pregnancy. Out of 119 clinics that participated in the survey, they collectively treat over 7,000 patients with ketamine monthly, with an estimated one-third comprising women of childbearing age.
Key findings
Over 75% of the clinics that responded stated they have a formal process for screening for pregnancy, yet only 20% require a pregnancy test to be conducted at least once prior to or during treatment.
More than 90% of clinics acknowledge that pregnancy is a contraindication for ketamine therapy in their consent forms or during discussions with patients. Nevertheless, less than half actually talk to patients about the specific risks related to ketamine use.
The researchers assessed informed consent documents on the websites of 70 other ketamine clinics. They found that 39% did not include any mention of pregnancy, and those that did often used vague language.
Regarding contraception advice, only 26% of surveyed clinics discuss the potential need for contraception with ketamine patients, and under 15% recommend or require the use of contraception during treatment.
This situation is particularly notable, the authors argue, because over 80% of clinics reported offering long-term ketamine maintenance therapy, with nearly 70% stating that many patients receive care for over six months, with some treated for a year or longer.
Analysis of records from 24 patients treated at U-M’s ketamine clinic indicated that all had taken a pregnancy test before beginning treatment and continued weekly testing, yet documentation showing they were using contraception was only present for half of those patients.
Inspiration for the study
Dr. Rachel Pacilio, the lead author and a psychiatrist at Michigan Medicine, formulated the idea for this study during her rotation in the perinatal psychiatry clinic.
Pregnant patients or those who had recently given birth approached her about ketamine as an option for their treatment-resistant depression after hearing about its potential effectiveness when administered intravenously or as a nasal spray called Spravato, which is FDA approved.
“Guidance for prescribers is minimal, primarily advising to avoid ketamine in pregnant patients due to the uncertain effects on a developing fetus or a breastfeeding newborn,” noted Pacilio. “This prompted us to investigate how clinics manage these considerations in their intake and treatment processes, particularly during maintenance therapy. To our knowledge, this is the first analysis of its kind.”
Variation in oversight
Infusion therapies using ketamine necessitate specialized personnel and monitoring after administration. Additionally, the FDA mandates a minimum of two hours of in-person observation following an intranasal Spravato dose to ensure patient safety and identify any complications.
Conversely, other ketamine treatments may be given in non-clinical settings with much less oversight. Some clinics even reported providing sublingual ketamine for home use.
The study did not include direct-to-consumer ketamine providers who conduct consultations solely via telehealth. The methods these companies use to address reproductive and safety concerns remain largely unexamined, despite their increasing patient appeal.
“Our findings suggest that many patients could be pregnant or may become pregnant while undergoing ketamine treatment through various administration methods. This risk escalates with prolonged therapy that can extend for weeks or even longer for maintenance,” explained Pacilio. “Many women may not realize they are pregnant in the initial weeks, and animal studies raise serious concerns regarding potential fetal harm during this timeframe.”
Pacilio highlighted that while many psychotropic drugs have been thoroughly examined and deemed safe for use during pregnancy—including numerous antidepressants—there is no supporting data for the use of ketamine in treating psychiatric disorders during pregnancy.
She also pointed out that the FDA’s risk mitigation guidelines for Spravato lack any provisions regarding pregnancy. Furthermore, a warning released by the FDA regarding risks associated with compounded ketamine available online also omits any mention of pregnancy precautions.
“The differences in practices among clinics in this study are striking,” stated Pacilio. “There is a clear need for standardization in reproductive counseling, pregnancy screening, and recommendations for contraception usage throughout ketamine treatment.”
If a patient becomes pregnant while receiving ketamine therapy and must discontinue the drug for the duration of their pregnancy, they may face a relapse of depression that could persist postpartum. Both perinatal and postpartum depression pose significant risks for the health of both the mother and infant.
Need for standard guidance
After presenting their findings related to U-M patients in this study to the leadership of U-M Health’s ketamine clinic, Pacilio shared that the clinic started advising patients on using reliable contraception if they were capable of becoming pregnant while on ketamine.
Smaller community clinics offering ketamine treatment might lack the resources of a large institution like U-M’s; therefore, standard guidance could be particularly beneficial for them.
Measures such as enhanced patient education emphasizing the necessity of pregnancy prevention during the entire ketamine treatment, regular pregnancy screening prior to and throughout the treatment for appropriate individuals, and effective contraception counseling are crucial. Many of these could be implemented easily and have a significant positive influence on public health.
“Ketamine is an incredibly effective and potentially life-saving treatment for suitable patients, but it isn’t right for everyone,” she stated. “It’s our responsibility as psychiatrists to ensure the delivery of this treatment is done safely and beneficially for patients.”
In a commentary published in the journal discussing U-M’s findings, psychiatrist and journal editor Marlene Freeman, M.D., emphasized the urgent need to establish and implement best practices regarding ketamine and esketamine for women of reproductive age. She noted this is especially important given the evolving legal landscape regarding abortion.
Freeman also mentioned that individuals who have taken ketamine in any form during pregnancy, alongside other psychiatric medications, can enroll in the National Pregnancy Registry for Psychiatric Medications to help gather critical information regarding the effects of these medications.
Other authors of the study include Dr. Jamarie Geller, a psychiatry fellow at U-M, and faculty members Dr. Juan F. Lopez, Dr. Sagar V. Parikh, and Dr. Paresh D. Patel.
This study received funding from the U-M Department of Psychiatry.
