FDA Requires Black Box Labels on Opioids

painkiller morphine bottleJust after the Centers for Disease Control (CDC) released finalized guidelines for prescribing opioids for chronic pain, the United Stated Food and Drug Administration (FDA) announced that they will require immediate-release painkiller prescriptions to notify users that that drug has a “black box” warning, alerting users of the possible risks of abuse or overdosing.

There are extended-release opioids and there are immediate-release opioids. Extended-release drugs have more opioid in each dose than immediate-release, but it takes longer for the medicine to circulate so patients (hopefully) will take fewer pills. Immediate-release drugs do not have as much opioid per dose and patients may need to take more of them, roughly every four to six hours versus closer to every 12 hours for extended-release. The majority of prescriptions, up to 90 percent according to the FDA, are written for immediate-release drugs.

The “black box” warning will be printed on the bottle of the prescription when it is filled, and then it is up to patients to see that their drug has a black box warning and gather more information. They can go to the manufacturer’s website to see the details of that black box warning. Pharmacists are encouraged, but not necessarily required, to distribute guides along with the filled prescriptions that will explain the risks of the drug they are getting. Though every instant-release opioid drug now has a corresponding guide available, as of now it looks like it will be up to the pharmacist to decide whether or not they give patients the guide along with their medicine.

The black box warnings will be placed on labels of 87 branded pharmaceuticals and 141 generic pharmaceuticals.

This kind of warning was placed on extended-release drugs in 2013 because the FDA initially thought the extended-release drugs were the bigger culprit in the abuse epidemic. After following the results of that initial labeling effort it seems as if the epidemic has not slowed down and so the administration is taking the step to label all prescription opioids.

The CDC’s guidelines encourage physicians and patients to explore alternative treatment options beyond opioid therapy, and when opioids are prescribed they should be prescribed in the lowest dose possible.

Some, like FDA Commissioner Robert Califf, are optimistic that the new labels will have an impact on the abuse problem, but others think it comes too late in the epidemic.

Senator Ed Markey from Massachusetts said that it took the administration too long to confront the risks of opioids and there is more that can be done to help solve the problem beyond placing labels on medication. He suggests the administration start using external advisory committees when a new opioid drug comes to them for approval.

“We also need requirements to ensure all prescribers of opioid painkillers are educated in safe prescribing practices and the identification of possible substance use disorders,” Markey said.

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