December 21, 2023 – The FDA has approved the primary test that uses DNA to evaluate whether people could also be at higher risk of becoming hooked on opioids.
The prescription test, called AvertD, is meant for use before administering oral opioids for acute pain – for instance, before patients undergo planned surgery. It is meant for adults who haven’t taken oral opioid pain medications previously. And it is just not intended for patients with chronic pain, the FDA said.
“The opioid crisis, one of the most profound public health problems in the United States, requires innovative measures to prevent, diagnose and treat opioid use disorders, including assessing the risk of developing the disorder,” said Jeff Shuren, MD, of the FDA in a opinion. “This approval represents another step forward in the FDA’s efforts to prevent new cases of OUD, support the treatment of people with this disorder, and reduce the misuse of opioid analgesics.”
A DNA sample is taken through a swab of the cheek. The test then examines a variety of genetic variants that could possibly be related to the next risk of developing opioid use disorder. Reuters reported.
“The addictive nature of painkillers has fueled an opioid epidemic that has resulted in more than half a million overdose deaths in the United States over more than two decades,” Reuters wrote.
The important risks related to AvertD are false negatives and false positives, Shuren said. “The risks of false negatives and false positives can be partially mitigated through accurate, transparent product labeling and a training program for healthcare providers.”