MCDANIEL ASKS FDA FOR NEW WARNINGS ON PRESCRIPTION PAIN PILLS

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May 13, 2013

LITTLE ROCK – Attorney General Dustin McDaniel and other state attorneys general called on the U.S. Food and Drug Administration today to strengthen warnings about the risks of prescription painkiller use during pregnancy.

McDaniel and 42 other attorneys general sent a letter to the FDA asking the agency to place a “black box” warning on opioid analgesics to inform pregnant women about the risks of Neonatal Abstinence Syndrome (NAS) in newborn children. NAS is caused when infants who have been exposed to painkillers through their mother’s prenatal use suddenly lose their opioid drug supply at birth. The withdrawal of opioids can cause symptoms in newborns that include tremors, vomiting, high-pitch crying, hyperactivity, weight loss and failure to gain weight.

“As the prescription drug abuse problem grows here and Arkansas and across the country, hospitals are seeing increasing numbers of infants who are born with serious health problems as a result of their mothers' painkiller abuse,” McDaniel said. “There are very serious risks associated with using narcotics during pregnancy, and we must do everything we can to make sure expectant mothers and health-care providers are fully aware of those risks.”

In 2009, approximately one infant was born each hour in the United States with NAS, meaning those children have significantly greater chances of having respiratory issues, low birth weight, feeding difficulties and seizures. That same year, nationwide health-care costs associated with treating NAS were estimated at $720 million. Medicaid paid for the majority of those treatment costs.

While NAS is treatable, the best course of action is to prevent the disease from occurring in the first place, the attorneys general wrote in their letter to the FDA.
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With the letter, McDaniel and other state attorneys general continued their efforts to combat prescription drug abuse, which is the fastest growing drug problem in the United States. The Centers for Disease Control and Prevention has classified prescription drug abuse as an epidemic. Prescription drug abuse is the leading cause of accidental death in the United States and it now accounts for more deaths nationally than traffic accidents.

In April, the FDA heeded the bipartisan advice of McDaniel and other AGs by blocking generic drug manufacturers from producing a crushable generic form of OxyContin, a drug that has fueled addiction and overdoses across the country.
 

Attorneys General's Letter to the FDA

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