Doctors Urge FDA to Pull Genetic Opioid Marker Test Kit from Shelves

Doctors Urge FDA to Pull Genetic Opioid Marker Test Kit from Shelves

More than 30 prominent physicians across the country have signed a petition asking the FDA to reconsider its controversial decision to approve the opioid drug test AvertD. The drug, manufactured by SOLVD Health and approved by the FDA in 2022, claims to be able to check users for 15 genetic markers that make them susceptible to opioid use disorder. In theory, physicians who administer AvertD can be forewarned if patients have a greater susceptibility to becoming addicted to any pain medications that contain opioids.

However, as reported by NBC News, doctors have questioned AvertD’s promise. In their letter addressed to FDA Commissioner Robert M. Califf, AvertD’s ability to detect genetic markers predisposed to opioid addiction is not “any better than chance.” Studies have shown that the drug has a 20% chance of generating false positives–indicating that clients are likely to become addicted when they are actually not–or false negatives, in which a physician might assume that patients wouldn’t get addicted and over-prescribe medications.

In either case, one in five clients either had a false sense of security that they were immune from opioid addiction, or they were left stigmatized and deprived of needed medications.

In their letter, the doctors noted that, back in 2022, the FDA’s own review panel had highly recommended that the drug be rejected. Genetics, the panel had warned, was only one factor to consider. Opioid use disorder can be shaped by social and environmental factors, as well as the frequency of exposure.

The opioid crisis has called for innovation and, occasionally, taking chances on new medications that have yet to be fully proven to be effective. At times, the agency has had to reverse its decisions on drugs that can do more harm than good. In 2017, the FDA requested that Endo Pharmaceuticals recall its opioid medication Opana ER.

As for AvertD, the FDA has yet to respond to the petition.

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