Pa. A.G. Kane, others urge FDA to place black box warning on opioid analgesics

By Jon Campisi | May 16, 2013

Pennsylvania’s top law enforcer was one of among 42 state attorneys general from across

Pennsylvania’s top law enforcer was one of among 42 state attorneys general from across

the country this week who urged the U.S. Food and Drug Administration to place a black box warning on opioid analgesics to note the risk of Neonatal Abstinence Syndrome.

The syndrome, which is caused by opioid withdraw at birth in babies who had been exposed to the drug through their mother’s pre-natal use, can cause infants to experience tremors, vomiting, high-pitch crying, hyperactivity, weight loss and failure to gain weight.

“As use of prescription opioid analgesics increases, so do the instances of NAS,” the attorneys general wrote in their collective correspondence sent out to the FDA. “We therefore believe that a black-box warning for these medications would help ensure that women of childbearing age, as well as their healthcare providers, are aware of the serious risks associated with narcotic use during pregnancy.”

According to a press release from the office of Pennsylvania Attorney General Kathleen Kane, it was estimated in 2009 that more than 13,000 newborn babies across the country came into this world with NAS.

The infants have a significantly greater chance of developing respiratory issues, low birth weight, feeding difficulties and seizures, according to the press release.

“While NAS is a treatable disease, the best course of action is to prevent it from occurring in the first place,” the release states.

In addition to the top prosecutors from all six New England states, other states’ attorneys general who signed the letter to the FDA include, but are not limited to, California, Colorado, Delaware, Illinois, West Virginia, Washington, Missouri, Nevada, Georgia, Maryland and New Mexico.

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