Product News and Recalls

Lawmaker warns of crisis for newborns

U.S. Senator Charles Schumer of New York is calling for a nationwide effort to combat the problem of babies born addicted to prescription painkillers or other opiates, known as Neonatal Abstinence Syndrome (NAS).

In a news release on the issue, Schumer cites a study published in the Journal of the American Medical Association (JAMA), which found that approximately 3.4 of every 1,000 infants born in 2009 suffered from NAS. That amounts to roughly one infant born with the syndrome every hour.

One of the policy initiatives Schumer wants is for the U.S. Food and Drug Administration (FDA) to finalize a long-stalled 2008 rule providing more information for pregnant women on prescription drug labels. 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.

The possibility of women unknowingly harming their newborns by taking prescription drugs has been a concern for other types of medication as well. A number of studies have linked certain antidepressants known as selective serotonin reuptake inhibitors with birth defects in newborns, including potentially deadly heart and lung conditions.

SSRI antidepressants include Zoloft and Prozac.

Schumer’s news release quotes Philip Roth, M.D., PhD., Director of Neonatology and Chairman of the Department of Pediatrics at Staten Island University Hospital, as saying there’s been a steady increase in the frequency of neonatal abstinence syndrome from 1.3 to 3.0 to 8.0 cases per 1,000 live births from 2010 to 2012. And while previous cases were primarily babies born to mothers on methadone, more than 50% of the current cases are born to mothers on prescription opiates.

Health problems associated with NAS include low birth weight, birth defects and even long-term learning impairments.

Schumer’s other proposed initiatives include:

  • The Substance Abuse and Mental Health Services Administration (SAMHSA) educating doctors so 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) doing more research that will help future mothers avoid addiction.

Patients should consult their doctors before making any changes in their medication. A consultation with an SSRI lawyer is also important if there are significant injuries from SSRIs.

See Schumer’s news release here:

https://www.schumer.senate.gov/record.cfm?id=337167&