Ketamine Poses Serious Risks for Pregnant Women, But Providers Often Fail to Warn Them
Clinics that administer ketamine for mental health issues often fail to adequately warn patients of the serious risk ketamine poses for pregnant women, according to a new study from the University of Michigan.
It has long been known that ketamine — which can be addictive — “readily and rapidly” crosses the placental barrier.
Research on animals has shown serious neurotoxic effects in offspring exposed to ketamine in utero. These effects include neuronal cell death, abnormal brain development and serious behavioral, cognitive and affective abnormalities that mirror schizophrenia, among other issues.
The authors of the study said ketamine should not be used during pregnancy. They recommend pregnancy testing before treatment and the use of contraception during treatment, and said treatment should end if a woman becomes pregnant.
The National Institutes of Health (NIH) reports that nearly half of the pregnancies in the U.S. are unplanned. Many people who are treated with ketamine for psychiatric illness are women who may become pregnant.
The study, published in the Journal of Clinical Psychiatry, found that ketamine prescribers aren’t paying enough attention to this risk. The authors concluded that more needs to be done to ensure that patients taking ketamine are not pregnant and won’t become pregnant during their treatment.
The researchers surveyed ketamine clinics across the country and analyzed informed consent documents found online.
They also examined the medical records of patients from a University of Michigan medical clinic to determine whether women there who were given ketamine were taking pregnancy tests and using contraception during their treatment.
The study authors found a wide variation in policies, practices and warnings about ketamine and pregnancy among the 119 clinics that responded to their survey. Collectively, the clinics treat more than 7,000 patients per month, about a third of whom are women of childbearing age.
Lead author Dr. Rachel Pacilio told Science Daily :
“These data suggest that a large population of patients could be pregnant, or could become pregnant, while receiving ketamine treatment via multiple routes of administration. This risk increases with the duration of therapy which can last weeks for the initial course and a year or more for maintenance. …
“Many patients do not know that they’re pregnant in the first weeks, and animal studies of ketamine are very concerning for potential harm to the fetus during this time.”
Ketamine use on the rise
In recent years, ketamine has gained traction as a promising alternative therapy for treatment-resistant depression, post-traumatic stress disorder and other mental health conditions that haven’t responded to other treatments.
The drug is “generally considered safe,” according to the paper, but there are “significant gaps in knowledge” about its effects in “special patient populations,” such as pregnant women.
But the therapy is very new, as is the scientific data supporting its safety and efficacy.
The 119 responding clinics in the study comprise a small percentage of the 500-700 ketamine clinics KFF Health News reported have recently “cropped up” across the U.S. The industry, valued at $3.1 billion in 2022, is projected to more than double to $6.9 billion by 2030.
Ketamine is a Schedule III drug, making it about as easy to access as Tylenol with codeine.
The U.S. Food and Drug Administration (FDA) approved the drug for general anesthesia during surgery and as a sedative in some settings.
Only one formulation — the intranasal esketamine, sold under the brand name Spravato — is approved for treatment-resistant depression. However generic forms of the drug are commonly used off-label to treat psychiatric disorders.
The common off-label use means there aren’t standard protocols for how to safely administer the drug. Evidence-based guidelines are limited and treatment can vary significantly in terms of the dose, frequency, method of administration and duration of treatment, according to the paper.
Clinics that offer intravenous ketamine or the FDA-approved nasal version often require in-person monitoring post-administration to monitor for safety and prevent the patient from driving after administration.
However, other clinics prescribe sublingual ketamine for at-home use and safety protocols are unknown. Online services like Mindbloom and Nue Life also offer the drug at home, without an in-person visit to a prescriber, often in the form of lozenges shipped from compounding pharmacies, MedPage Today reported. These types of prescribers were not included in the study.
The FDA’s risk mitigation program, meant to ensure that benefits outweigh risks for drugs with serious safety concerns, has no provisions for the use of Spravato during pregnancy, according to Pacilio.
The agency last year issued a warning about the dangers of compounded ketamine, but said nothing about pregnancy.
Prescribing information for the approved form of the drug indicates that prescribers should specifically advise patients about the potential risk of fetal harm resulting from in utero ketamine exposure. However, prescribers are not provided with information about how to effectively counsel women, the study found.
Recent controversy around the death of actor Matthew Perry has also revealed that the addictive potential of ketamine is unknown and more people are also abusing the drug as it becomes more widely available.
‘The field is really in need of standardization’
Over 75% of the clinics that responded to the survey, said they have a formal pregnancy screening process, but only about 20% required a pregnancy test.
However, less than 50% of the clinics warned patients to avoid pregnancy during treatment or explained the specific risks related to pregnancy exposure to patients. Informed consent documents at those clinics had a pregnancy warning only about half the time.
In their examination of informed consent documents on the websites of 70 other ketamine clinics, the researchers found that 39% did not include language about pregnancy in their documents, and those that did were generally vague.
Regarding contraception counseling, only 26% of responding clinics said they discuss the need for contraception and less than 15% of clinics recommend contraception during treatment.
These findings were particularly concerning, according to the researchers, because most clinics prescribed long-term courses of ketamine treatment, ranging from six months to more than a year.
Their review of patient records from 24 women treated with ketamine at the University of Michigan clinic showed that all of them had taken a pregnancy test before treatment, but only half had documentation of contraception in their medical records.
The study concluded that as ketamine treatment becomes more widely available and prescribed, there is a growing need to inform women about the serious risks during pregnancy.
“The variability in practice that we see among clinics in the community in this study is stark,” said Pacilio.
“The field is really in need of standardization around reproductive counseling, pregnancy testing and the recommendation for contraception during ketamine treatment.”
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
September 8, 2024 -
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