by Brenda Baletti, Ph.D., Childrens Health Defense:
Ketamine — which can be addictive — “readily and rapidly” crosses the placental barrier, and can cause serious birth defects if taken by pregnant women. Its use is on the rise, but prescribers are failing to warn women of the risks, a new study found.
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.
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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.
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