Crafting better drug labeling to ensure safer use of opioids

By: Margaret A. Hamburg, M.D.

One of the FDA’s primary public health missions is ensuring that healthcare providers and their patients have all the information they need to help decide whether a medication is safe and appropriate to use.

Margaret Hamburg, M.D.Communicating the full risks and benefits of a drug becomes all the more important for those medications that are potentially deadly if used incorrectly. Extended-release long-acting(ER/LA) opioids fall into that category, and can sometimes cause serious harm, like addiction, even when used properly.

These medications, which include drugs such as morphine, oxycodone, and fentanyl, can improve the quality of life for many people who must live every day with pain. But ER/LA opioids often also contain a large amount of the active ingredient, sometimes in sufficient quantity to be lethal, and they are a prime target of drug abusers.

As part of FDA’s efforts to address the serious risks of ER/LA opioids, we looked more closely at the product labeling, known by many as the package insert, to determine whether this essential tool for conveying information about a drug should be revised to encourage safer use.

We closely reviewed medical literature and evaluated public input. We then came to the conclusion that if we improved what the labeling says about proper patient selection and the risks from these drugs, we might be able to reduce the frequency of bad outcomes.

And so today I’m pleased to announce new, proposed labeling changes for ER/LA opioid pain relievers, as well as new postmarket requirements that will include additional studies and clinical trials to better assess certain significant questions about the risks and safety practices of these drugs. The goal is to achieve safer and more appropriate use of these potent pain relievers.

These labeling changes better describe the risks associated with the ER/LA opioid medications and clarify the population for whom the benefits of these products outweigh their risks.

Rather than stating that these medications are indicated “for the relief of moderate to severe pain in patients requiring continuous, around-the clock opioid treatment for an extended period of time,” once final, the updated label will clarify that these products are indicated for “management of pain severe enough to require daily, around the clock, long-term opioid treatment and for which alternative treatment options are inadequate.”

And in the section of the label regarding limitations of use, we have added language plainly stating just how risky these drugs are — even at recommended doses.

In addition, we are requiring changes to the boxed warning for these products to give greater emphasis and prominence to the risk of Neonatal Opioid Withdrawal Syndrome that may occur in newborns due to prolonged opioid exposure during gestation.

We know that the way a patient characterizes pain is always going to be subjective: “moderate” pain for one patient may be “severe” pain to another. And we recognize that there are some women who have an appropriate need for opioids during their pregnancy.

The goal of all of these labeling changes is to help physicians work with their patients to determine whether these potent pain relievers are the most appropriate treatment for their specific situation and if so, to help them in managing their use.

While our intent is to encourage safer and more appropriate use of these products, simply changing the labeling won’t make an impact if these changes are not understood and integrated into practice by healthcare providers. So I am urging prescribers to spend some time going over this new labeling, when final, reflecting on what the language means to their practice, and communicating what they’ve learned to their patients.

The fact is, improving the safe and appropriate use of ER/LA opioids takes the help and commitment of all of us, including our partners in the healthcare community. We are committed to working together to help ensure that healthcare providers can prescribe ER/LA opioids properly and better monitor and educate their patients.

Margaret A. Hamburg, M.D., is the Commissioner of the Food and Drug Administration

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