FED UP! is pleased with the new FDA prescribing information for prescription opioids, which places greater emphasis on the risks of opioids, of higher doses of opioids, and of longer-term continuation of opioids.  

However, the new prescribing information continues to underestimate the risks of opioid addiction. It discusses results of two studies of new opioid users, and says the rate of development of addiction over 12 months on opioids was 1-6%, defining addiction as moderate-severe opioid use disorder, using DSM-5 criteria.

1. The 6% figure includes only moderate-severe OUD.

What about mild OUD?

The medical term for addiction is opioid use disorder. That includes mild OUD.

Mild OUD is not a benign condition. Addiction is a progressive illness. Mild OUD frequently goes on to become moderate-severe OUD.

The most recent NSDUH study found that mild OUD is approximately twice as common as moderate-severe OUD.

If that ratio applies here, approximately 18% of those in the study developed OUD using the DSM-5 definition, not 6%.

• The 6% figure uses the DSM-5 definition of (moderate to severe) opioid use disorder. This definition is automatically modified so that physiologic effects of chronic opioids (dependence, withdrawal) are not counted toward opioid use disorder.

Although the prescribing information says the 1% figure comes from DSM-5 criteria, it does not. The 1% figure comes from criteria newly developed for this study.  The criteria remove a number of the DSM-5 criteria if the patient says they are motivated by a desire to reduce pain.

We know that addiction is a disease of denial. Many people who are developing addiction believe they are taking medication to reduce pain.

We will be requesting that the FDA correct these underestimates of the incidence of OUD in these two studies, so that prescribers and patients will be better able to assess the risks of prescription opioids.