Attorneys General Seek Warning Label Cautioning Pregnant Women Against Using Pain Pills

Forty-threestate attorneys general are calling for new “black box” warning labels on prescriptionpainkillers that can harm unborn children.

Ina letter sent Monday to the U.S. Food and Drug Administration, the attorneysgeneral point to an alarming spike in the number of babies born with “neonatalabstinence syndrome,” or drug withdrawal symptoms experienced by babies whenthey are cut off from the opioid drugs ingested by their mothers. The symptomsinclude tremors, seizures, poor weight gain and fever.

“Webelieve that a ‘black box warning’ for these medications would help ensure thatwomen of childbearing age – as well as their health care providers – are awareof the serious risks associated with narcotic use during pregnancy,” theattorneys general wrotein the letter addressed to FDA Commissioner Margaret Hamburg. The targetedmedications include popular painkillers such as OxyContin, Vicodin, codeine,morphine and methadone, which are part of the same opioid family of drugs asthe illegal drug heroin.

Nationally,about 13,500 infants were born with drug withdrawal symptoms in 2009, about onebaby each hour, according to a 2012 studyfrom the Journal of the American Medical Association.

Theproblem is particularly pronounced in certain states. In Kentucky, for example,instances of neonatal abstinence syndrome have increased 2500 percent over 10years, from 29 cases in 2001 to 730 cases in 2011, according to the attorneygeneral’s office in that state. 

Babiesborn with neonatal abstinence syndrome require more care and risk lifelonghealth problems. Medicaid, a joint state-federal program, bears much of thecost: In Florida, where seven of every 1,000 infants born in 2011 experiencedopioid withdrawal symptoms, Medicaid paid for treatment for 77 percent of thosebabies, at a total cost of about $32 million, according to a report on prescriptiondrug abuse and newborns. The rate of opioid-exposed babies born in Florida morethan tripled between 2007 and 2011, from 2.3 to 7.5 per 1,000 live births.

In Tennessee, theaverage cost to the state Medicaidprogram of a baby born with neonatal abstinence syndrome was $40,931 in 2010.That compares with $7,258 in Medicaid benefits for a healthy birth, accordingto the Tennessee Department of Health. The state rankedsecond in the country for number of retail prescriptions filled per person, at17.6 prescriptions filled per person in 2011.

The black box labels theattorneys general are calling for are found on prescriptions which cause themost serious side effects, including anti-depressants or heart medications. Thenew warning labels would be added to any existing black box labels on thedrugs. For instance, OxyContin already comes with a black box label warningabout its potential for abuse.