FDA Announces ‘Black Box’ Warning for Opioid Meds

The Food and Drug Administration (FDA) has announced that fast-acting opioid pain relievers will have now be required to have “black box” warnings. These labels warn about the risk of abuse, addiction and overdose.

As reported in Governing:

The new FDA guidelines announced Tuesday call for the prescription labels to warn that opioids can cause a dangerous central nervous system reaction if they interact with antidepressants and migraine medications.

Labels will also warn that opioid use can cause a rare condition in which the adrenal glands don’t produce enough cortisol, a hormone that helps the body handle stress. New labels will also explain that long-term opioid use is associated with lower sex hormone levels and reduced interest in sex, as well as impotence and infertility.

The article also notes the new CDC guidelines on opioid prescriptions and HHS efforts to expand access to naloxone as part of the nation’s continued fight against opioid abuse.

The Department of Health and Human Services also has asked state Medicaid directors to include naloxone on their list of covered medications, Frieden said, so that more friends and families of abusers have access to the lifesaving drug.

The flurry of activity comes after the CDC issued new guidelines last week that call for doctors to try less addictive painkillers, like aspirin and ibuprofen, before prescribing opioids to patients.

The guidelines, which are not mandatory, recommend that opioids be prescribed mainly for short-term pain episodes of three to seven days.

For more information read the full article in Governing.