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FDA Wants Generic Narcotic Painkillers to Be Abuse-Deterrent

One more step to combat the epidemic of potent painkiller abuse

By Steven Reinberg
HealthDay Reporter

THURSDAY, March 24, 2016 (HealthDay News) -- Continuing their push to combat the nation's epidemic of prescription painkiller abuse, U.S. officials on Thursday urged generic drug makers to take steps to redesign potent drugs such as hydrocodone and oxycodone to make them harder to abuse.

U.S. Food and Drug Administration officials said they were encouraging the generic drug industry to develop pain medicines with "abuse-deterrent properties." For instance, this would make it harder to crush a tablet to snort the contents or dissolve a capsule to inject its ingredients.

"By issuing the draft guidance, the FDA is helping to ensure that generic abuse-deterrent opioids are no less abuse deterrent than their brand-name counterparts," FDA Commissioner Dr. Robert Califf said during a morning press briefing.

"We hope that the availability of less costly generic products with abuse-deterrent properties has the potential to accelerate the shift away from the older products that do not include abuse-deterrent properties," he said.

The FDA is also requiring makers of brand-name narcotic painkillers with approved abuse-deterrent labeling to conduct long-term studies to see how effective the formulas are in reducing abuse in the real world.

The agency said it realizes that these formulas aren't foolproof and more research is needed.

But, given the lower cost of generic drugs, encouraging access to such drugs with abuse-deterrent properties is an important step toward reducing narcotic abuse while helping to "ensure access to appropriate treatment for patients in pain," the FDA said.

The draft guidance includes recommendations about studies that should be done to prove that a generic drug is no less abuse-deterrent than a brand-name one. The FDA is asking for feedback from the generic drug industry during a 60-day comment period.

On Tuesday, the FDA announced that certain opioid drugs -- such as Oxycontin, Percocet and Vicodin -- will get new "boxed warnings" about the dangers of misuse.

And last week, the U.S. Centers for Disease Control and Prevention announced new recommendations for doctors who prescribe such drugs.

The CDC advisory stressed that doctors -- especially primary care physicians -- should try to avoid prescribing addictive opioid painkillers whenever possible for patients with most forms of chronic pain.

For example, this would include patients suffering from joint or back pain, dental pain (tooth extraction, for example), or other chronic pain treated in an outpatient setting.

It would not include the use of narcotic painkillers for people dealing with cancer-related pain, or terminally ill patients in palliative care, the CDC said.

In December, the CDC announced that fatal drug overdoses had reached record highs in the United States -- driven largely by the abuse of prescription painkillers and another opioid, heroin. Many abusers use both.

According to the December report, more than 47,000 Americans lost their lives to a drug overdose in 2014, a 14 percent jump from the previous year.

More information

There's more on the epidemic of prescription painkiller abuse at the U.S. National Institutes of Health.

SOURCE: March 24, 2016, news conference with Robert Califf, M.D., commissioner, U.S. Food and Drug Administration

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