Every year in the United States, thousands of infants are born who have been exposed to illicit or prescription drugs prenatally, especially the abuse of pain-killing opiates like Oxycontin and Vicodin.
U.S. Senator Charles E. Schumer is calling for the FDA to change prescription drug labels to better warn pregnant women about their dangers to their unborn babies.
The troubling fact is one baby, per hour, is born addicted to prescription drugs and other opiates.
According to a study published in June 2012 in the Journal of the American Medical Association (JAMA), approximately 3.4 of every 1,000 infants born in 2009 suffered from NAS or Neonatal Abstinence Syndrome. NAS has increased 500% in the past 2.5 years.
Outcomes are staggering for innocent babies.
Senator Schumer is offering a three-point plan to address this crisis:
–The FDA must do a better job to inform patients about the dangers of abuse of prescription opiate use during pregnancy and to provide clear labels so that women and doctors know the potential dangers of the medication, particularly painkillers.
–The Substance Abuse and Mental Health Services Administration (SAMHSA) must do a better job to educate doctors so that they’re better able to identify the symptoms of prescription drug abuse in pregnant mothers.
–The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) must do more research in order to help future mothers avoid addiction.
Schumer is also asking the FDA to finalize a long-stalled 2008 rule that made much-needed revisions to prescription drug labels for pregnant women. The FDA’s 2008 Proposed Rule on Requirements for Pregnancy and Lactation Labeling is designed to facilitate informed counseling about the prescribing of medicines for women who are pregnant, breastfeeding, or of child-bearing age.
According to Schumer, the FDA has proposed much needed changes to the current pregnancy labeling system of categories A, B, C, D, and X but he is deeply concerned that four years have passed and still the rule is not final.
We thank Senator Schumer for his aggressive stance in trying to change the lax status quo by educating doctors and pregnant women about the harmful and life threatening side effects prescription painkillers on their babies.