U.S. Senator Charles E. Schumer today, joined by doctors from Staten Island University Hospital, New York University School of Medicine, and Lutheran Medical Center called for a nationwide plan to combat the alarming trend in New York and across the nation of infants being born addicted to prescription painkillers or other opiates, known as Neonatal Abstinence Syndrome (NAS). According to a study published in the Journal of the American Medical Association (JAMA) last month, approximately 3.4 of every 1,000 infants born in 2009 suffered from NAS, roughly one infant born with the syndrome every hour. In previous years, only a handful of babies were born addicted to painkillers -- now that number has skyrocketed in New York and around the country: at Staten Island University Hospital, the number of babies born with Neonatal Abstinence Syndrome has increased 500% in the last two and a half years. The study comes on the heels of an epidemic of prescription drug abuse in New York and across the country, much of which has resulted in violent crime.
"It's become a sad fact that the latest victims of the prescription drug crisis in this country are the most vulnerable in our society, innocent babies," said Schumer. "About one baby per hour is born addicted to prescription drugs or other opiates, and we must act now to reduce that alarming statistic and prevent this growing trend from spiraling out of control."
"There are approximately 3,000 babies born at Staten Island University Hospital every year - this has been stable for the last three years. In this borough, there is a high rate of use and abuse of prescription opiates like oxycontin and vicodin. From 2010 to 2012 (YTD), there has been a steady increase in the frequency of neonatal abstinence syndrome from 1.3 to 3.0 to 8.0 cases per 1,000 livebirths. While previous cases were primarily babies born to mothers on methadone maintenance, the present cohort consist of greater than 50% born to mothers on prescription opiate," said Philip Roth, M.D., PhD., Director of Neonatology and Chairman of the Department of Pediatrics at Staten Island University Hospital.
"Thousands of infants are born each year in the United States who were exposed to illicit or prescription drugs prenatally. While we have not conducted formal studies as of yet, this is a serious problem that we confront on a regular basis in New York City. I applaud Senator Schumer's efforts to help combat this issue that affects not only babies and their families, but the entire health care system as a whole," said Sean Bailey, Director of the Neonatal Simulation Training Program, and Tisch Hospital Site Director of the NYU Pediatric Residency Program at the New York University School of Medicine.
"Lutheran Medical Center, in partnership with the American College of Ob/Gyn, is proud to stand beside U.S. Senator Charles E. Schumer as he fights against the recent increase in Neonatal Abstinence Syndrome (NAS). By addressing addiction in pregnant mothers, increasing training of doctors to recognize this condition, revising medication labeling, and expanding the funding for research and data collection, we can help to decrease the number of innocent lives that are affected by NAS," said Dr. Hoskins, Chair and Residency Director, Department of Ob/GYN at Lutheran Medical Center in Brooklyn.
In the face of this new report, Schumer is offering a three-point plan to address the crisis. First, he is calling on the Food and Drug Administration (FDA) to do a better job informing patients of the dangers of prescription drug use during pregnancy and to provide clear labels so that women and doctors know the potential dangers of the medication they're taking, particularly for painkillers. Secondly, Schumer is pushing the Substance Abuse and Mental Health Services Administration (SAMHSA) to educate doctors so that they're better able to identify the symptoms of prescription drug abuse in pregnant mothers. Lastly, he is asking the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) to do more research that will help future mothers avoid addiction.
Neonatal Abstinence Syndrome can lead to a number of disturbing health problems in children, such as low birth weight, birth defects and even long-term impairments in the way children learn. Schumer highlighted that the number of babies born addicted to prescription opiates has nearly tripled in the past decade, according to the latest data. In the Journal of the American Medical Association (JAMA) study published in May, it was revealed that approximately 3.4 of every 1,000 infants born in 2009 suffered from NAS -- roughly one infant born with the syndrome every hour. New York hospitals, including Staten Island University Hospital have already stated they have seen an uptick in cases on babies born to prescription drugs.
NAS is the withdrawal response that occurs when an infant is exposed, in utero, to addictive drugs being taken by the mother. NAS symptoms are characterized by irritability, tremors, hypertonicity, vomiting, and diarrhea. Schumer noted the devastating impact that NAS has on babies and their development. Drug exposure in utero has been shown to reduce birth weight and head circumference in infants. There are also long-term cognitive and behavioral problems associated with infants who have NAS. Beyond the devastating personal toll, the AMA study showed that the public cost of NAS is growing exponentially. In 2000, total hospital charges associated with NAS amounted to $190 million; by 2009, they had risen to $720 million, and about three quarters of these costs are financed through Medicaid.
As part of his plan to address NAS, Schumer called on the Food and Drug Administration, in conjunction with the Substance Abuse & Mental Health Services Administration, to implement a three point plan to reverse the trend.
First, Schumer is calling for the U.S. Food and Drug Administration (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 childbearing potential. Schumer noted in a letter to the FDA that finalization of this rule is long overdue and implementation would play an significant role in helping pregnant women and their health care providers avoid taking and prescribing medications that may increase the risk of dependence during pregnancy. A 2011 study of all medications approved by the FDA from 1980 to 2010 found that 91% of medications approved for use by adults had insufficient data to determine the risk of using the medication during pregnancy.
Second, Schumer called on the Substance Abuse and Mental Health Services Administration (SAMHSA) to provide more adequate information and provide greater training to doctors to properly identify and treat cases of babies born. Specifically, SAMSHA's Center for Substance Abuse Treatment (CSAT) plays a critical role in the fight against prescription drug abuse, and Schumer is urging the CSAT to work to find ways of increasing knowledge about treatment available to opioid-addicted pregnant women to minimize damage to both mother and child.
Under the Data Addiction Treatment Act of 2000, physicians are eligible to receive a waiver to administer narcotic drugs to treat opiate addiction. Prior to the Data Addiction Treatment Act of 2000, physicians seeking to treat opiate addiction with narcotic drugs like Soboxone or Methodone were required to obtain separate registration. Schumer is urging SAMHSA to do more to encourage physicians to sign up for the waiver to increase the number of available physicians to treat addicted pregnant women.
Lastly, Schumer urged the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) to extend and expand their research into NAS. While the CDC has flagged prescription-painkiller abuse as a major health threat to pregnant mothers and their children, Schumer pointed to a chronic information deficit involving NAS. Exposure to painkillers in utero can have a devastating impact on babies in the short and long-term, and Schumer is urging more research to increase awareness of the issue and to allow health providers and officials develop to powerful plans to combat this growing trend.
A copy of Schumer's letters appears below:
June 11, 2012
The Honorable Margaret Hamburg, M.D.
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Dear Commissioner Hamburg:
I write today to urge the Food and Drug Administration (FDA) to finalize the May 29, 2008 Proposed Rule on Requirements for Pregnancy and Lactation Labeling. A 2011 study of all medications approved by FDA from 1980 through 2010 found that 91% of the medications approved for use by adults had insufficient data to determine the risk of using the medication during pregnancy. Data suggest that women receive an average of 3 to 5 prescriptions during each pregnancy and that 64% of pregnant women use at least 1 prescription drug.
While FDA is to be applauded for proposing much needed changes to the current pregnancy labeling system of categories A, B, C, D, and X, I am concerned that four years have passed and still the rule is not final.
I am particularly concerned about the delay because of recent published research that has found that every hour one baby is born suffering from drug withdrawal. A study published in May in the Journal of the American Medical Association estimated that in 2009 more than 13,000 babies were born with neonatal abstinence syndrome (NAS), a withdrawal syndrome that occurs in some babies after being exposed to a class of opiates, while in utero.
As you know, prescription drug abuse is a terrible epidemic in the U.S. and I believe we need to do everything possible to combat this issue, including helping pregnant women and their health care providers to avoid medications that may increase risk of dependence during pregnancy. It is also critically important to help addicted pregnant women to seek medical care that will reduce the risk of NAS.
Thank you for your consideration.
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