No Increased Adverse Event Risk With Naltrexone

No Increased Adverse Event Risk With Naltrexone
No Increased Adverse Event Risk With Naltrexone

Healthcare professionals should feel confident in continuing to prescribe naltrexone for opioid and alcohol addiction as the drug doesn’t cause more adverse events compared to a placebo.

Researchers examined 89 randomized, controlled trials that enrolled nearly 11,200 people and involved oral naltrexone; studies involving opioid or ex-opioid users were excluded. Most of the trials studied alcohol-use disorder, though others included smoking, psychiatric disorders and impulse control disorders.

Side effects associated with naltrexone include nausea, vomiting, abdominal pain, decreased appetite and dizziness. The drug used to have a “black box” warning about a risk for drug-induced liver damage, but this has since been removed from its labeling.

While there was no increased risk of serious adverse events for naltrexone compared to placebo, a second analysis showed six marginally significant adverse events for naltrexone, though they were deemed mildly severe, according to results published in BMC Medicine.

“Though this drug is licensed for the treatment of alcohol addiction, it remains underutilized,” lead author Monica Bolton, MD, of the University of Manchester (UK), said in a statement. “It is cost-effective and could reduce deaths.”

Naltrexone is also available as a long-acting injection under the brand name Vivitrol.

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