Citing the risk of neonatal abstinence syndrome (NAS), the National Association of Attorneys General (NAAG) has sent a sign-on letter to the Food and Drug Administration (FDA) calling for a “black box” — the most serious — warning label on opioid analgesics — painkillers. Sponsored by Pam Bondi, attorney general of Florida, and Jack Conway, attorney general of Kentucky, the letter said that NAS “caused by maternal opiate use has increased at alarming levels.” NAS is the withdrawal syndrome newborn babies go through when their mothers were taking opioids — methadone or buprenorphine for addiction, or opioid analgesics for pain — on a long-term basis prior to delivery.
The letter includes a description of NAS as a “malfunction of the autonomic nervous system, respiratory system and gastrointestinal tract.” Withdrawal signs “may include: abnormal sleep patterns, tremors, vomiting, high-pitch crying, irritability, hyperactivity, seizures, weight loss and failure to gain weight.” What the letter does not say is that women who are dependent on opioids who go through withdrawal, even medically supervised withdrawal, during pregnancy put their fetus at risk.
Bondi and Conway both take a strong stance against prescription drug abuse, and as attorneys general view the problem more as one of law enforcement than one of public health. They are the co-chairs of the NAAG substance abuse committee and are guiding the association’s substance abuse agenda, in which prescription drug abuse is elevated.
According to the letter, the black box warning “would help ensure that women of childbearing age — as well as their health care providers — are aware of the serious risks associated with narcotic use during pregnancy.” They suggest the following language for the content: “Warning: Use of narcotic analgesics in pregnant women may cause neonatal abstinence syndrome.”
The article cited a 2012 article published in the Journal of the American Medical Association on the costs of NAS — an article that gave rise to a barrage of headlines referring to babies as “addicted” (see ADAW, May 7, 2012). The letter also states that Medicaid paid for 77.6 percent of the costs.
Many studies of methadone
Stating that “there are NAS treatment protocols,” the letter added that data about optimal treatments is “sparse.” In fact, there is a solid body of literature on NAS for babies when the mothers were in methadone treatment for addiction, noted Charles P. O’Brien, M.D., professor of psychiatry at the University of Pennsylvania. “There are many studies of the use of methadone for addiction treatment in pregnant women,” he told ADAW. Methadone is so much safer for the fetus than heroin because it doesn’t have the peaks and valleys, he said. In addition, for women already on opioids, their fetus would go through a very dangerous withdrawal, he said. While there are not many studies on the use of opioids for pain for pregnant women, he said, “I think a pregnant woman in pain should be able to take opioids.”
O’Brien recalled that when he took his boards in neurology, he was given two infants to examine — both of whom had opioids in their system. “Both were being treated and were doing well,” he said.
“When top-ranking law enforcement officials make health care
pronouncements it’s not surprising that they get it wrong,” said Robert Newman,
M.D., director of the Baron Edmond de Rothschild Chemical Dependency
Institute of Beth Israel Medical Center
Noting that addiction is a medical problem, he said that “what should have
been advocated is widespread public service announcements that dependence on opioids
-- prescription painkillers as well as illicit drugs such as heroin – can be
treated with excellent outcomes for both mother and child, and that no
treatment has been found to be as safe and effective as maintenance with
methadone or, more recently, buprenorphine,” he said.
“Furthermore, with regard to the neonatal abstinence syndrome,
the attorneys general seem oblivious to the fact that at the first signs of
occurrence long-standing, evidence-based treatment protocols exist that can
preclude the suffering they spell out in such detail in their letter,” he said.
“When suffering does occur, it generally is an indication of inappropriate
and/or inadequate care of the newborn.”
AGs urge ‘prevention’ of NAS
The AGs’ letter said that the “best course of action” is “prevention” of NAS, implying that pregnant women should not take opioids.
We contacted the press office of New York Attorney General Eric Schneiderman, who did not sign the letter, and the press office of Massachusetts Attorney General Martha Coakley, who did. Schneiderman’s office did not get back to us, and Coakley’s press officer declined to comment, except for saying they would let the letter “speak for itself.”
NAAG Communications Director Marjorie Tharp explained the sign-on process for letters. First, each letter needs two sponsors — a Democrat (Conway) and a Republican (Bondi). The two sponsors, who are also co-chairs of the association’s substance abuse committee, crafted the letter, and then asked NAAG to send it out to all 56 AGs — in all states and territories. “All the AG offices get a cover letter from the two sponsors explaining the topic, and then giving them the deadline by which to sign, or not sign, the actual letter,” Tharp told ADAW. If there are 36 or more signers, the letter is then sent.
There is no significance to an AG not signing a letter, said Tharp. “We don’t know what their reasons are,” she said.
The FDA did not respond to requests for information about their response to the AG letter.
For a copy of the letter, go to http://www.naag.org/assets/files/pdf/signons/Final%20FDA%20NAS%20Warning%20Label%20Letter.pdf.