FDA Mandates Opioid Label Changes

Wednesday, September 18, 2013 | 0

The U.S. Food and Drug Administration announced Sept. 10 that it will require fairly significant changes to the labeling of all extended-release and long-acting opioid analgesics. First, the good news.

A drug's "label" is the tool the FDA uses to inform the physician community of the approved uses, risks and safety concerns of all drugs it approves for use. Going forward, the labels for all extended-release and long-acting (ER/LA) opioid analgesics will include the following changes:

1) "ER/LA opioid analgesics are indicated for the management of pain severe enough to require daily, around the clock, long-term opioid treatment and for which alternative treatment options are inadequate."

This effectively removes the current indication for ER/LA opioid analgesics for moderate pain and focuses the indication for ER/LA opioids on severe pain only. This may not seem like a big deal (and as you'll read later, it may lead to little change in prescribing behavior), but the FDA has taken a clear stand here: ER/LA opioids are dangerous and should not be used for anything but severe pain.

2) "The updated indication further clarifies that, because of the risks of addiction, abuse and misuse, even at recommended doses, and because of the greater risks of overdose and death, these drugs should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain; ER/LA opioid analgesics are not indicated for as-needed pain relief."

This statement is essentially reflective of the FDA catching up with what we've practically known for some time: these drugs are dangerous at any dose and should only be used to treat patients for whom all other potential treatments have been tried and failed. Now, however, conversations with prescribing physicians who have not tried alternative treatments can be based, at least in part, on a conversation around why they're prescribing ER/LA opioids "off-label." While they have every right to do so, this creates an opportunity to educate the physician community about the new FDA label language.

Finally, the new labeling will also include warnings about the potential for Neonatal Opioid Withdrawal Syndrome (NOWS), one of the saddest consequences of the opioid epidemic. And FDA is also going to require more post-market safety studies focused on addiction and abuse issues.

All great news, right? It's a good sign, but it's unlikely to impact prescribing behavior in the short term.

The FDA does not regulate the practice of medicine. While the new label language will slow down pharmaceutical marketing efforts (albeit temporarily), prescribing physicians are still free to use medications as they see fit, even beyond what the FDA label indicates.

So there's still a great deal of work to do. But the FDA has used its authority, however limited, to help us fight the battle against prescription drug misuse and abuse.

Michael Gavin is chief strategy officer for Prium, which provides medical management services to the workers' compensation industry. This column was reprinted with his permission from the firm's Evidence Based blog.