Dozens of state attorney generals are asking the Food and Drug Administration to issue a “black box” warning about the danger of pregnant women using opioid painkillers. A recent study found that opioids can cause neonatal abstinence syndrome, which occurs when infants suddenly lose their opioid drug supply at birth.
“We write to you today out of concern for the health and well-being of newborn children. The opioid epidemic has taken the lives of many of our citizens and has affected nearly everyone in this nation, including newborn children,” the letter from 43 states attorney general to FDA commissioner Margaret Hamburg states.
The primary cause of neonatal abstinence syndrome (NAS) is maternal opiate use during pregnancy.
Symptoms of NAS include the malfunction of the autonomic nervous system, respiratory system and gastrointestinal tract. Signs of withdrawal usually present themselves within 24 hours to several days after delivery and include abnormal sleep patterns, tremors, vomiting, high-pitched crying, irritability, hyperactivity, seizures, weight loss and failure to gain weight.
Onset, duration and severity vary with the painkiller used, the amount and timing of the mother’s last dose, and the rate at which the drug is eliminated from the infant’s body.
“We believe that a black box warning for these medications would help ensure that all women of childbearing age - as well as their health care providers - are aware of the serious risks associated with narcotic use during pregnancy,” the letter states.
A black box warning is the sternest warning by the FDA that a medication can carry and still remain on the market. It is designed to call attention to serious or life-threatening risks of using the drug.
The attorneys general suggested the warning could read: “Use of analgesics in pregnant women may cause neonatal abstinence syndrome.”
“As the use of prescription opioid analgesics increases, so do the instances of neonatal abstinence syndrome (NAS). Both the human and financial costs are alarming,” they write.
In the letter, the attorneys general cite a 2012 study in the Journal of the American Medical Association that found treating a single newborn with NAS in 2009 cost about $53,400, with a total estimated cost of approximately $720 million that year. Medicaid paid for more than 77 percent of the treatment.
The letter comes just two months after most of the same attorneys general wrote the FDA asking the agency to require generic drug makers to produce tamper-resistant versions of medicines that contain opioids.
The FDA has sent mixed signals about tamper-resistant formulations, which are designed to prevent people from crushing and snorting drugs.
Last month the agency approved new labeling for the painkiller OxyContin that allows Purdue Pharma to maintain its monopoly on the drug by blocking cheaper generic versions from entering the market. The new labeling states that a tamper resistant version of OxyContin reduces the chances of abuse. Purdue Pharma began selling the tamper resistant version in 2010.
In January, however, the FDA allowed Impax Laboratories (NASDAQ: IPXL) to begin selling a generic version of Opana, another powerful painkiller, that is not tamper-resistant. That decision was reaffirmed last week when the agency denied a citizens petition from Endo Health Solutions to require generic Opana to be tamper resistant.