She drank kratom tea during her pregnancy. Then his newborn went back

The woman had been using oxycodone for almost ten years but had told her doctors that she had been sober for two years. She never touched narcotics during her pregnancy, she said, and completed her rehabilitation.

But his newborn son was withdrawn: nervous, screaming and needing an infusion of morphine to stay alive. The child was thirsty for drugs, but why?

In the midst of an epidemic of opioids, the young man's doctors have not accused heroin, fentanyl or other illicit substances. Instead, they said, the infant had become addicted to a controversial herbal supplement: kratom.

"A false sense of security"

According to a case report published Wednesday in the journal Pediatrics, the unnamed woman and her baby both took a drug test in urine that specifically looked for oxycodone and other opioids. . But these tests did not seek kratom, a legal drug with effects similar to those of opioids in high doses.

The plant, which is native to Southeast Asia, is generally used to treat pain and reduce cravings for opioids. Acting on the same brain receptors as morphine and similar drugs, some view it as a solution to the epidemic of opioids, but the US Food and Drug Administration considers it a potentially dangerous psychoactive drug.

The mother denied using substances during her pregnancy – legal or otherwise – but her husband told the doctors that she drank kratom tea every day to treat her withdrawal symptoms and facilitate her sleep.

"I'm concerned that women who are sincerely committed to breaking their addiction do not develop a false sense of security by using a substance presented as a non-opioid alternative," said Dr. Whitney Eldridge, neonatologist at BayCare Health System. Florida. lead author of the case report.

The mother may have been well-intentioned, but since the tests did not show any other medications either at home or at the child's, her doctors stated that the kratom was probably at the origin of the condition of his son, known as Neonatal Abstinence Syndrome. On the eighth day of his life, after being weaned off opioids and observed without any medication, the boy was sent home.

This is rare, but Dr. Scott Gottlieb, Commissioner of the FDA, said in a statement that "this case is not unique". He added that the FDA "is aware of four other cases involving neonates exposed to kratom while they were in utero and that they had a neonatal opioid withdrawal syndrome after childbirth. in the future ".

Gottlieb, whose agency has issued various warnings about kratom, described the new report as a "tragic case of harm" and said "this incident further illustrates the FDA's concerns about kratom, including the potential for abuse and dependence ".

And although Eldridge hopes that more research will help legislators better regulate kratom, she thinks that today, doctors "must inform pregnant women of the risk of kratom, just like any other substance. which may have adverse effects on the newborn ".

Experts call for caution and cast doubt

Some experts are reluctant to draw conclusions from the report. They note that, although the use of kratom by the mother may theoretically cause neonatal abstinence syndrome, the case has not explicitly linked kratom to infant withdrawal symptoms.

"I'm not surprised that this is possible," said Dr. Andrew Kruegel, associate researcher at Columbia University, "because kratom has opioid effects and can induce tolerance among users, particularly at higher doses ".

But Kruegel, who has been studying the plant for seven years, noted that doctors were not able to test the so-called kratom. "The main limitation is that we do not know anything about the dosage taken by the mother," he said. "Without this information, you can not really extrapolate too much."

And the mother might not have taken kratom at all, said Dr. Edward W. Boyer, an associate professor at Harvard Medical School and a doctor in the department of emergency medicine. Brigham Hospital and Women & # 39; s.

"It's the husband who reported the use of kratom," he said. "The woman who actually ingested the product, who thought it was kratom, and the authors of the case relate, none of these people actually verified that she was ingesting kratom. "

The rocky past and the uncertain future of kratom

Despite warnings from the FDA, kratom is easy to buy and is sometimes sold as tea in coffee shops. The non-profit American association Kratom estimates that between 3 and 5 million Americans use the substance, and the group says it's open to warning labels on products based on kratom.

"We think that, as in many supplements, it should be warned that pregnant women should not take this," said Dave Herman, president of the association. "It's not because we think it's detrimental, it's because it's a safety measure."

Kratom acts on opioid receptors, which, according to the FDA, is evidence of its potential for abuse. The agency reports 44 deaths related to kratom, but Kruegel said that "if you look at these 44 deaths, the vast majority of them involve other substances, including other opioids strong ".

Boyer said the kratom could carry other risks, such as seizures, but he added that it could be safer than most opioids because "there does not seem to be any respiratory depression when kratom is used alone ".

Respiratory depression – slow and inefficient breathing – is what makes opioid overdose so lethal. That's why Boyer thinks that a well-regulated kratom could one day be used in the fight against opioid addiction, by moving users away from more dangerous drugs.

"If you do the right thing and do the rigorous studies, then there is no reason for that [kratom] should not be a prescription drug product that serves as a gateway to official drug therapy, especially for people who can not take therapy, "said Boyer.

Challenges for the development of kratom medicines

The American Kratom Association says that pharmaceutical companies have little incentive to study kratom as a potential prescription drug, especially because they can not patent the raw plant.

"If I'm a pharmaceutical company, I think launching a new drug on the market costs between $ 1.2 billion and $ 1.8 billion, according to your interlocutors," said Herman. "Who would spend that money when another guy could just get on a boat, go down a river and catch him from a tree?"

Since kratom is considered a dietary supplement, manufacturers do not need the FDA's approval to sell it, provided their products do not claim to cure or treat specific conditions or symptoms.

But some companies did just that, drawing FDA's anger for declaring that their products could "relieve opioid withdrawal" or "treat a myriad of diseases." The association says that these cases are anomalies.

"In fact, we believe it's America," Herman said. "And if a product is useful for your health and well-being, you should have the right to take it, as long as it does not harm you, and we have not seen any evidence of that harm. "

The FDA however continues to warn against kratom, even suggesting that it could worsen the epidemic of opioids.

"Kratom has never been studied in humans," Gottlieb said in a statement. "What consumers and health care providers need to understand is that there is no proven medical use of kratom. Instead, as the FDA has warned, kratom can cause serious damage and contributes to the opioid crisis. "