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Enhanced warnings for opioids
US Food and Drug Administration (FDA) has announced class-wide enhanced labelling warnings for:
immediate-release opioid pain medications, in relation to risks of misuse, abuse, addiction, overdose and death similar to those added to modified-release formulations in 2013;
immediate-release and modified-release formulations, in relation to the undesirable effects on the endocrine system, and also the potential for interaction with other medicines resulting in serotonin toxicity.
The updated indication for immediate-release opioids states that they should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (eg, non-opioid analgesics or opioid combination products) are inadequate or not tolerated. The dosing information also provides clearer instructions regarding patient monitoring and drug administration, including initial dosage, dosage changes during therapy and a warning not to abruptly stop treatment in a physically dependent patient. In addition, a precaution that chronic maternal use of opioids during pregnancy can result in neonatal …