The woman had used oxycodone for almost a decade but had her doctor for two years. She never touched narcotics during her pregnancy, she said, and had completed rehab.
Her newborn son was in jittery, screaming and requiring an infusion of morphine to stay alive. The infant craved drugs, but why?
Amid opioid epidemic, the boy's doctors did not blame heroin, fentanyl or other illicit substances. Instead, they said, the infant had grown dependent on a controversial herbal supplement: kratom.
'A false sense of safety'
According to a case report published Wednesday in the Journal Pediatrics, both of which are specifically for urine drug screens and specifically for oxycodone and other opioids. But those tests did not look for kratom, a legal drug that has opioid-like effects at high doses.
The plant, which is native to Southeast Asia, is typically used to treat pain and curb opioid cravings. It is said that it is a potential dangerous psychoactive drug by the US Food and Drug Administration.
The mother denied using any substance during her pregnancy – legal or otherwise – but her husband.
As a non-opioid alternative, "said Dr. Joshua," I fear that women are making a false sense of safety by using a substance that is advertised as a non-opioid alternative. Whitney Eldridge, a neonatologist for Florida's BayCare Health System.
Kratom probably caused her son's condition, known clinically as neonatal abstinence syndrome. On his eighth day of life, after he had been released off opioids and without any medications.
It's rare, but FDA Commissioner Scott Gottlieb said in a statement that "this case is not unique." He said the FDA is "aware of other cases involving neonates exposed to cratom while in utero who has experienced neonatal opioid withdrawal syndrome after term delivery."
Gottlieb, whose agency has published a report on kratom, has published the "a tragic case of harm" report, and said it has published a report on the issue of "kratom, including the potential for abuse and addiction."
Though Eldridge hopes to help lawmakers better regulate kratom, she believes that physicians today "need to find out about the risk of kratom as they would do any other legal substance that can have ill effects on their newborn."
Experts urge caution, cast doubt
Some experts are hesitant to draw any conclusions from the report. They note that although maternal kratom could theoretically cause neonatal abstinence syndrome, the case did not explicitly link to the infant's withdrawal symptoms.
"I'm not surprised that this is possible," Dr. Andrew Kruegel, an associate research scientist at Columbia University, "Because of the opioid effects and tolerance in users, especially at higher doses."
Kruegel, who has studied the plant for seven years, said that doctors were not able to test the purported kratom itself. "The main limitation is that we do not know anything about that." "Without that information, you can not really extrapolate too much."
The mother might not have taken kratom at all, said dr. Edward W. Boyer, an Associate Professor at Harvard Medical School and a Physician at the Department of Emergency Medicine at Brigham and Women's Hospital.
"It's the husband who reported the kratom use," he said. "The wife who actually ingested the product, who thought it was kratom, and the authors of the case report, none of them actually verified that ingesting kratom."
Kratom's rocky past and uncertain future
Despite the FDA's warnings, kratom is easy to buy and sometimes sold as a tea in cafes. The nonprofit American Kratom Association estimates that 3 million to 5 million Americans use the substance, and the group says it's open to warning labels on kratom products.
Dave Herman, the association's chairman, said "We believe that in many supplements, there should be no warning that pregnant women should not take this." "That's not because we think it's detrimental. It's because it's a safety measure. "
Kratom acts on opioid receptors, which the FDA says is its potential for abuse. The agency points to 44 deaths associated with kratom, but Kruegel said that "if you look at those 44 deaths, the vast majority of them involve other substances, including other strong opioids."
Boyer said kratom may have other risks, such as seizures, but he may have said it safer than most opioids because "there does not seem to be respiratory depression when kratom is used alone."
Respiratory depression – slow and ineffective breathing – is what makes opioid overdoses so deadly. That's why Boyer believes well-regulated kratom could one day be used in the fight against opioid addiction, driving users away from more dangerous drugs.
"If you do the right thing and do the rigorous studies, then there is no reason why [kratom] should not be a prescription pharmaceutical that serves as a bridge to formal drug treatment, especially for individuals who can not get into therapy, "Boyer said.
Challenges to developing kratom-based drugs
The American Kratom Association says there's little incentive for pharmaceuticals to study as a potential prescription drug, especially because they can not patent the raw plant.
"If I'm a drug company, I think it's somewhere, depending on who you speak, between $ 1.2 and $ 1.8 billion to bring a new drug to market," Herman said. "Who would spend that kind of money on a boat, ride down a river and grab it off a tree?"
Because kratom is considered a dietary supplement, manufacturers do not need FDA approval.
Some companies have just done that, drawing the FDA's "relieve opioid withdrawal" or "treat a myriad of ailments." The association says these cases are anomalies.
"The reality is, our belief is, this is 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 opioid epidemic.
"Kratom has never been studied in humans," Gottlieb said in the statement. "What consumers and health providers need to understand is that there are no proven medical uses for kratom. Instead, the FDA has warned, kratom can cause serious harm and is contributing to the opioid crisis. "