FDA Urges Creation of Generic Abuse-Deterrent Opioid Painkillers

FDA Urges Creation of Generic Abuse-Deterrent Opioid Painkillers

The Food and Drug Administration (FDA) is urging makers of generic drugs to redesign opioid painkillers to make them abuse-deterrent, according to HealthDay.

Medications with abuse-deterrent properties are more difficult to crush or dissolve, making them harder to snort or inject.

If a medication has abuse-deterrent properties, “it does not mean the product is impossible to abuse or that these properties necessarily prevent addiction, overdose or death – notably, the FDA has not approved an opioid product with properties that are expected to deter abuse if the product is swallowed whole,” the agency said in a statement.

“By issuing the draft guidance, the FDA is helping to ensure that generic abuse-deterrent opioids are no less abuse deterrent than their brand-name counterparts,” FDA Commissioner Dr.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. “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.”

The FDA will also require makers of brand-name opioid painkillers with abuse-deterrent labeling to conduct long-term studies on the effectiveness of the formulas in reducing abuse.

Last week the FDA announced it is requiring immediate-release opioid painkillers to carry a “black box” warning about the risk of misuse, abuse, addiction, overdose and death.

Immediate-release opioids are usually intended for use every four to six hours, while extended-release opioids are generally intended to be taken once or twice a day. According to the FDA, 90 percent of opioid prescriptions are for immediate-release opioids. The FDA placed black-box warnings on extended-release opioids in 2013.
Bottles for immediate-release opioids will have a notification stating there is a black-box warning for the drug. Patients will need to go to the manufacturer’s website for details, the article notes.

Pharmacists will be encouraged to give patients a medication guide explaining the risks of the drug.

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