FDA Issues New Safety Alert, Labeling Requirements; PAINWeek Faculty Expert Comments

Earlier this week, the US Food and Drug Association (FDA) issued a Safety Communication warning about safety concerns across the entire class of opioid medications. FDA is requiring new warning labels for opioids, in a step that the agency said would address the specific risks identified, and as a positive response to the escalating epidemic of opioid abuse in the US. The new labeling requirements predominantly affect immediate release (IR) opioids, constituting about 90% of the prescriptions written. In 2013, FDA strengthened labeling requirements for extended release/long acting (ERLA) opioid medications. In its Communication, FDA identified 3 risks to be highlighted in the strengthened warning labels:

  • Opioid interaction with antidepressants and migraine medications can cause serotonin syndrome, a serious central nervous system reaction
  • Opioids may cause adrenal insufficiency and inadequate production of the stress modulating hormone, cortisol
  • Long-term opioid use may be associated with decreased sex hormone levels and symptoms that include reduced interest in sex, impotence, and infertility

The new labeling requirements, including new black box warnings, will apply to 87 brand-name medications and 141 generics, as compared to just 34 products impacted by the 2013 initiative. “It’s a pretty massive effort” observed FDA medical products commissioner Robert Califf, MD.

For comment on the FDA initiative, we contacted senior PAINWeek faculty member and scientific poster committee chair Joseph Pergolizzi, MD. Dr Pergolizzi is also a member of the FDA Safe Use Initiative, adjunct assistant professor at Johns Hopkins University School of Medicine, and senior partner, Naples Anesthesia and Pain Associates, Inc. Voicing support for the FDA action, he characterized it as a move toward more appropriate opioid prescribing, in line with the dictum of ‘first doing no harm’ when deciding on potential therapies for pain patients. The effort to bring IR labeling into alignment with ERLA labeling is a recognition that risks exist across the class: “Just because it’s an IR doesn’t mean it’s ‘opioid lite,’” Dr. Pergolizzi noted. For example, pregnant women who are on chronic opioid therapy don’t skirt the risk for neonatal opiate withdrawal syndrome just because they are taking an immediate release and not an extended release product. He further suggested that single entity central acting agents, such as tapentadol, that provide multimechanistic analgesia may represent a better therapeutic option for some pain conditions. “Be real smart. There may be other reasons why the pain is happening, and if you don’t want to use combination therapy, think about a drug that has a multimechanistic analgesic approach.”

Dr. Pergolizzi also weighed in on the recently released CDC Guideline for Prescribing Opioids, as covered in several previous PAINWeek Daily Dose stories. “CDC is confronted with a tough public health problem,” he noted, “and I think they’re giving guidance to primary care doctors that hopefully will result not in decreased access to these medications but in more appropriate prescribing and better understanding by primary care doctors. Because there are not enough pain specialists to take care of 110 million pain patients.”

To read the Daily Dose about the Guideline, click here.

A news story about this week’s FDA action may be read here.

The FDA Safety Communication and notice of label change requirements may be read here.







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