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Tuesday, June 18, 2019  Spokane, Washington  Est. May 19, 1883
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FDA panels urge stronger minimum dosages of naloxone

By Tony Pugh Tribune News Service

WASHINGTON – A rise in overdose deaths from heroin laced with fentanyl and other powerful additives prompted two federal advisory committees on Wednesday to recommend that the Food and Drug Administration authorize stronger minimum dosages of naloxone, the lifesaving drug that reverses the effects of opioid overdose.

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 15-13 to recommend increasing the minimum amount for an injectable and intravenous dose of naloxone – currently 0.4 milligram – when considering approval of new naloxone products for use outside of a hospital or medical setting.

The recommendation of the panels, composed of academic experts, consumers and industry representatives, will be further explored by the FDA’s Center for Drug Evaluation and Research. No timetable for future action has been set.

The committees’ decision comes as authorities wrestle with an epidemic of overdose deaths from heroin laced with fentanyl and carfentanil, both powerful synthetic opioids. Florida, in particular the Manatee County area, has been particularly hard hit.

Opioids are a class of narcotic pain medications that include prescription drugs such as OxyContin, Percocet and morphine, along with the illegal drug heroin.

Fentanyl, the most powerful opioid available for medical use, is approved for acute, chronic pain from advanced cancer. It is up to 100 times more powerful than morphine and 40 to 50 times more powerful than heroin.

Ingesting doses of fentanyl as small as 0.25 milligram can be lethal. But most fatal overdoses involve illicit fentanyl produced in illegal laboratories. Fentanyl is also used to manufacture counterfeit versions of the anxiety and pain medications Xanax and oxycodone.

Carfentanil, which is used as a tranquilizer in large animals such as elephants, is 10,000 times more powerful than morphine and 100 times more powerful than fentanyl.

Last month, the Drug Enforcement Administration issued a warning to the public and law enforcement community nationwide about the health and safety risks of carfentanil.

The DEA issued a similar nationwide alert for fentanyl in March 2015, after seeing more than 700 fentanyl-related overdose deaths from late 2013 through 2014.

While naloxone can reverse an overdose from drugs laced with fentanyl and carfentanil, higher or multiple doses are often needed to revive patients because of the drugs’ higher potency.

The panels’ recommendation came after testimony from drug researchers and others that higher doses of naloxone increase the likelihood of acute opioid withdrawal syndrome, which can make patients combative, unpredictable and sometimes violent.

Because of that possibility, first responders and police may be reluctant to administer repeat or future doses of naloxone because of the unpredictability of patients.

Naloxone is currently available for sale to the public by several companies as an injectable product and as an intranasal spray, Narcan, by Adapt Pharmaceuticals. Some injectable naloxone products have also been modified for use as intranasal sprays by attaching a foam tip to the syringe, which acts as an atomizer when placed into the nostril.

The dosage amounts for these products range from 0.4 to 2 milligrams. Narcan contains 4 milligrams of naloxone per dose – of which nearly 2 milligrams are absorbed into the body, said Mike Kelly, Adapt’s president of U.S. operations.

The panels also voted 21-7 against recommending that the FDA approve different minimum dosing standards for children and adults. The minimum dosing range for adults and children is currently the same.

Some data supports treating children with a higher dose because they metabolize naloxone faster. Children typically come in contact with dangerous opioids accidentally in their homes.

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