FDA Eases Opioid Policy: No More Cold Turkey

In a new development in the continually-evolving federal policies toward opioids, the Food and Drug Administration (FDA) has issued labeling changes for prescription opioids which instruct physicians to taper, rather than cut off or cut down, opioid prescriptions—and prescribing detailed instructions to physicians on how to do so.

In making the policy change, the FDA is finally acknowledging facts which have emerged since the Centers for Disease Control (CDC) issued its 2016 guidelines on prescribing opioids—guidelines which were widely taken as a de facto rule.

“Recently, the FDA has received reports of serious harm, including serious withdrawal symptoms, uncontrolled pain and suicide, in patients who are physically dependent on opioid pain medicines when these medicines are suddenly discontinued or when the dose is reduced too quickly, often without adequate patient communication, follow-up or support,” the FDA said in an April 9 announcement under the name of Douglas Throckmorton, M.D., Deputy Director for Regulatory Programs of the Center for Drug Evaluation and Research.

“These practices have also been associated with patients attempting to find other sources of opioids in order to minimize their withdrawal symptoms or self-medicate for pain,” the statement said.

Those findings have been widely reported in the public news media since as early as 2016.

The announcement made what appears to be a statement more of policy than science, saying, “everyone who is treated with opioids for any length of time develops a physical dependence—meaning there are withdrawal symptoms if the treatment suddenly stops.”

According to a National Library of Medicine (NLM) online article, “everyone who takes opioids for an extended period will become dependent,” which seems like a more realistic statement. Also, scientific papers have been published, such as this 2018 study, which conclude that there are degrees of susceptibility to opioid dependence and addiction, which are genetically based.

The difference between “any” and “extended length” of time illustrates a key difficulty in figuring out how to wean patients off opioids. One of the tapering-off guidelines just issued by the FDA seems to adapt to this problem:

“There are no standard opioid tapering schedules that are suitable for all patients. A patient-specific plan should be used to taper the dose of the opioid gradually.”

A full set of the tapering-off guidelines is at this web page, which also offers a useful set of guidelines which a physician can pass on to patients (click on the “additional information for health care professionals” tab or the “Additional information for patients” tab.

Both the FDA statement and the NLM article agree that the “dependence” being discussed is not addiction, but a physical response in the body to opioids. The NLM article says, “only a small percentage also experience the compulsive, continuing need for the drug that characterizes addiction.”

The FDA statement defines addiction as, ”also involves behaviors, thoughts and feelings such as: a strong desire to take the drug; difficulties in controlling drug use; persisting in drug use despite harmful consequences; and a higher priority given to drug use than to other activities and obligations.”

The new tapering-off policy dovetails with two other FDA opioid prescribing initiatives we’ve previously reported on. The FDA is working with the National Academy of Science to develop evidence-based guidelines for prescribing opioids and plans to soon “require that immediate-release formulations of opioids be made available in fixed-quantity packaging—such as blister packs” which match typical dosages needed for acute pain.