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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

Drug Labels Need to Warn of Risks to Unborn Babies!

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In the United States of America, 3.4 out of every 100 babies, roughly one every hour, is born with one very serious roadblock to a healthy future; they are born addicted to prescription painkillers. For these infants, birth begins the difficult process of detoxification, also called Neonatal Abstinence Syndrome (NAS), characterized by sensitivity to light and noise, chronic crying and agitation, inability to relax muscles and occasionally, seizures. Babies with severe NAS are treated with graduated doses of morphine, decreased over time until the child can be weaned off the drug.

With prescription drug abuse among expectant mothers reaching epidemic proportions in some areas of the country, Senator Chuck Schumer (D- New York) is calling on the Food & Drug Administration (FDA) to place warning labels on prescription drug containers, similar to current cigarette and alcohol warnings, advising women of the potential hazards to their unborn children.

Currently, the FDA classifies opioid drugs, like the widespread oxycodone, as a Class C drug before thirty weeks gestation, and a Class D thereafter. The senator is also requesting cooperation from the medical community, in the form of increased training for doctors and other staff in recognizing the signs of NAS, and in the development and implementation of a national plan to combat the NAS epidemic. The National Institutes of Health (NIH) will also join in the fight for babies, by increasing research into prescription drug abuse and pregnancy.

A good case in point is the many Topamax lawsuits that are currently pending when it was discovered that the anti-seizure drug increases a woman’s chance of having a baby with cleft palate by double. Again, this is a clear indication that drug labels need to clearly warn to-be mothers of the serious and potential health risks associated with use of prescription drugs while pregnant so that they fully underestand the risks.