US doctors, researchers and health officials want FDA action to deter mis-prescribing of opioid painkillers

26 July 2012

Labels on opioid pain medications should be revised to prevent overprescribing, a broad coalition of doctors, researchers and public health officials said in a petition filed this week with the US Food and Drug Administration. If the requested changes were adopted, drug companies would not be able to claim that the pain medications are safe and effective for long-term use by non-cancer patients.

According to the petition, opioid labels are overly broad because they fail to limit opioid use to severe pain, to include a time frame for use and to specify a maximum dose. Presently, the label on opioid analgesics simply states that they’re approved for “moderate to severe pain.”

The requested changes relate specifically to when opioids are used for non-cancer pain. The petition calls for striking the term “moderate,” adding a suggested maximum dose equivalent to 100 milligrams of morphine and adding a suggested duration of use. The petition’s co-signers believe that preventing drug companies’ aggressive promotion of these medications for moderate pain will help curtail overprescribing. According to the Centers for Disease Control and Prevention, excessive prescribing of opioid analgesics is fueling an epidemic of addiction and overdose deaths.

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