Labeling changes for extended release, long acting Opioids approved by FDA

Recently, FDA has approved the class wide labeling changes for all extended release (ER) and long-acting (LA) opioid analgesics to limit their use to treat patients with severe pain. The changes in the labeling of these opioids were proposed in last September by Health regulator to highlight dangers of abuse and possible death, as well as risks to newborns of mothers taking the medicines.

The updated labels stated that the drugs are meant for pain severe enough to require daily, continuous, long-term opioid treatment, and are only for patients unable to achieve adequate pain relief with alternative medicines. Presently the labels indicated to treat patients with moderate and severe pain. Last year, the regulator had also said that the companies which market ER and LA opioid analgesics would have to conduct additional studies to assess the known serious risks of misuse, abuse, hyperalgesia, addiction, overdose and death.

Opioids include formulations of morphine, oxycodone, fentanyl and Oxycontin, a long-acting form of oxycodone. The label will also contain a harsher warning of the risks of addiction, abuse and misuse, even at recommended doses, and a warning that due to the risk of overdose and death, the drugs should only be used when other drugs are not strong enough to treat the pain or the pain cannot be tolerated, and not for as-needed pain relief.

The FDA’s harsher labels come as Massachusetts government banned Zogenix Inc.’s pain drug Zohydro ER, which obtained FDA approval in last October, from the state. The extended release analgesics are more problematic as they contain larger amount of active ingredients, leading drugmakers to respond in recent years with abuse-deterrent formulations that resist crushing.