Sen. Charles E. Schumer on Monday proposed three steps the federal government should take to stem the growing problem of newborns born addicted to prescription painkillers.
He called on the Food and Drug Administration to put into place proposed new rules for medication labels given to pregnant and breast-feeding women; the Substance Abuse and Mental Health Services Administration to educate doctors about opioid addiction in babies; and the National Institutes of Health and Centers for Disease Control and Prevention to conduct more research on women and newborns addicted to pain pills.
"Babies are the innocent victims of a prescription drug abuse epidemic," Schumer said at a news conference in the neonatal intensive care unit at Sisters Hospital.
The Buffalo News last year published a series, "Rx for Danger," that explored the spread of prescription painkillers into the illegal drug market, leading to drug abuse, addiction and death. A separate story detailed the growing concern in the Buffalo area over babies born with withdrawal symptoms, a condition known as neonatal abstinence syndrome.
The number of infants born addicted to opioid painkillers increased nearly threefold between 2000 and 2009, according to a study published in May in the Journal of the American Medical Association.
Schumer highlighted the study, which also found that the number of pregnant women addicted to prescription painkillers increased fivefold during the same period.
The rate of babies diagnosed with drug withdrawal symptoms increased from 1.2 per 1,000 infants born in the U.S. in 2000 to 3.4 per 1,000 in 2009, according to the study. In addition, the average cost of treating the infants rose from $39,400 to $53,400.
The research is the first to document the national incidence of the problem. It was based on billing data, which is subject to errors, and some of the increase may be the result of greater awareness by physicians of the problem of neonatal abstinence syndrome, the researchers noted.
Schumer said the new statistics suggest that one baby per hour is born addicted to prescription painkillers.
"Our society has an obligation to make sure every child has a chance to grow up healthy and succeed," he said.
In the early 2000s, staff at Sisters Hospital, a part of the Catholic Health System, might see two or three cases of neonatal abstinence syndrome a year, said Dr. Kamal Singhal, a neonatalogist. The hospital delivered more than 100 babies with the condition last year and treated about half of them, he said.
The symptoms of opioid withdrawal can vary depending on the drug but might include excessive crying, fever, hyperactive reflexes, irritability, poor feeding and slow weight gain.
Treatment includes small, tapering doses of morphine over a hospital stay of about one month, as well as such supportive care as swaddling the newborn and providing a quiet environment, Singhal said.
"We've seen a big increase in cases almost to epidemic proportions," he said.
The medical community, government and pharmaceutical industry are starting to grapple with the alarming rise in hospitalizations, deaths and illegal street sales from prescription painkillers. But the scope of the problem is enormous.
Americans comprise about 4.6 percent of the world's population, yet consume 80 percent of the supply of pain pills.
On medicine labeling, Schumer was referring to implementation of the FDA's 2008 proposed rules for labels that encourage informed counseling about the medications prescribed to women who are pregnant, breast-feeding or of child-bearing age. He wants the FDA to put new rules into effect.
His educational component calls on the federal Substance Abuse and Mental Health Services Administration to encourage more physicians to seek waivers to practice medication-assisted opioid therapy, an application that includes a requirement for training on painkiller use.
Finally, Schumer noted that little research has been done on addiction among pregnant women and their babies, largely because it is what he termed a "new and disturbing trend." He called on federal agencies that fund research to focus on the issue to learn more about it.