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New labeling, testing requirements for prescription drugs

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Amarillo, TX - More Americans than ever before are dying from prescription drug overdoses, and new federal requirements are trying to reverse that trend.

Prescription painkillers account for sixty percent of all drug-related deaths in the United States, which is more than deaths from cocaine and heroin combined.  So now new federal regulations are trying to keep more people alive with information. 

Earlier this month, the Food and Drug Administration announced new labeling requirements for prescription painkillers.  The new labels will outline in detail the very real risks of addiction, overdose, and death.  They will also specifically warn of the particular risk to unborn children and pregnant mothers.  Chronic use of painkillers can result in a potentially neonatal opioid withdrawal syndrome, which is when an unborn child develops an addiction through exposure.

"A prescription label is the most effective way that the FDA has to converse or communicate with physicians - that's one of their most direct ways to communicate with them," explains Dr. Kenna Payne, Assistant Professor at the Texas Tech University Health Sciences Center School of Pharmacy,  "So when they change the labeling, and the news that comes out with the labeling - so the FDA press releases, all those things - it's meant to educate both physicians and patients as well."

There are also new requirements for drug manufacturers as well, who will now have to conduct additional testing to more thoroughly assess any risks involved.

"The intent of the FDA is to make these drugs known to be not as safe as everybody seems to think they are," says Dr. Payne,  "They've actually required these companies to go back and do more tests, more studies to find out if there are more adverse effects that we don't know about."

The Centers for Disease Control reports fatal drug overdoses from prescription painkillers have tripled in the last twenty years - and their sales have quadrupled.  And today, the FDA is considering other efforts to educate both physicians and their patients to cut down on both over-prescribing and drug abuse.

"We don't know exactly what's going to happen yet, but the patients may actually get a sheet when they're prescribed these drugs that tell them about these drugs, and when it's best for these drugs to be used," says Dr. Payne.  "So the education, I don't believe is going to stop at the physician; I think it's going to continue to move and trickle down to the patient."

You can find out more about the labeling requirements and drug overdoses in the U.S. At the links attached to this story.

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