As overdose deaths from heroin laced with fentanyl and carfentanil continue to rise, a pair of Food and Drug Administration (FDA) panels have narrowly voted to recommend that the agency authorize higher minimum dosages for new naloxone products to better counteract the more potent street drugs.
In overdoses associated with fentanyl (100 times more powerful than morphine) and carfentanil (10,000 times more powerful than morphine), multiple doses of naloxone are sometimes required to revive an individual, especially at the current minimum standard of 0.4 milligrams.
By upping the naloxone minimum dosage, “we would be able to save the person’s life much quicker,” Heather Free, practicing pharmacist in Washington, DC, and spokesperson for the American Pharmacists Association, tells Addiction Professional. “We wouldn’t have to use second, third or fourth doses until we reached the maximum dose for that person. It would be more efficient and life-saving.”
The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and its Drug Safety and Risk Management Advisory Committee voted, 15-13, in favor of increasing the minimum amount for an injectable or intravenous dose of naloxone products used outside a hospital setting. No timetable for future action by the FDA regarding the committees’ recommendation has been set.
The underlying issue of addiction
Deaths due to fentanyl and carfentanil increased by 79% from 2013 to 2014, according to a report by the U.S. Centers for Disease Control and Prevention (CDC), which has prompted consideration of upping the naloxone minimum dosage.
Conversely, though, researchers have found that higher dosages of naloxone can increase the odds of a patient experiencing acute opioid withdrawal syndrome, which can make the patient combative and potentially violent. Free cautions that another potential drawback of increasing the minimum dosage is that it could embolden substance abusers to continue using.
“It doesn’t solve the problem that people are utilizing illicit drugs,” Free says. “The problem remains that people will use naloxone to save their lives and reverse things, but it doesn’t solve the issue of addiction. The FDA is leery about making it so available that people are able to have it there, and it doesn’t solve the issue.”
In addition to recommending higher minimum dosages of naloxone, the FDA panels voted against recommending that the FDA approve different minimum dosing standards for children and adults. Some research suggests children metabolize naloxone faster than adults, and would benefit from a higher dose.