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FDA To Add More Warnings To Opioid Medications


The FDA Tuesday announced required safety labeling changes for immediate release opioid pain medications, to warn both prescribers and patients of the risks of abuse, addiction and overdose.

Immediate release opioids are designed to be taken every four to six hours, as opposed to long-acting products which are taken once or twice a day.

Research shows opioid addiction usually begins with prescription abuse. Earlier this week, Dr. Michael Cozzi of Fort Wayne was arrested for over-prescribing controlled substances.

“80% of heroin addicts actually start with prescription opiates,” said Gov. Mike Pence this week as he signed several bills related to drug addiction. “Nearly a quarter of our teenagers have admitted to using a controlled prescription for non-medical reasons.”

The updated FDA warnings say that immediate release opioids should be used only if no other alternatives are adequate.

The FDA now also requires a warning that opioids during pregnancy can result in neonatal opioid withdrawal syndrome, which can be life-threatening.

This effort is part of the FDA’s partnership with the US Department of Health and Human Service to combat what they call a public health crisis.

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