FDA approves updated safety labels on all opioid painkillers

opioid oxycodone Shutterstock 329x210 FDA approves updated safety labels on all opioid painkillers The Food and Drug Administration (FDA) has approved updates to the boxed warning on all opioids reinforcing the risk of life threatening respiratory depression with use, the threat of neonatal opioid withdrawal syndrome when taken by pregnant women, and serious adverse events that could result if the powerful painkillers are taken with the anti-anxiety drugs benzodiazepines or other central nervous system (CNS) depressants including cough medicines.

Opioids include drugs such as oxycodone, morphine, codeine and heroin. They are primarily used for pain relief or anesthesia, and are also used to suppress cough and to treat diarrhea. Patients treated with the meds can develop a tolerance and dependence from continuous use and are at risk for withdrawal syndrome.

The euphoria the drugs offer makes them ideal for recreational use, which leads to addiction. Accidental overdose or use with other depressant drugs, such as benzos, commonly results in death from respiratory depression. As a result, most opioids are controlled substances.

In recent years, amid the growing prescription drug abuse epidemic, the FDA, the Drug Enforcement Administration (DEA), the Centers for Disease Control and Prevention (CDC), and other agencies have stepped up controls to curb the trend. For example, the FDA has ramped up warnings, and the CDC has issued recommendations to physicians to curb prescribing of the meds.

The FDA ordered the stronger warnings be added to the safety labels of all opioid painkillers in August following an extensive review of the latest scientific evidence.

FDA Safety Label Changes
FDA News Release