FDA identifies harm from discontinuation of opioids

Drug Safety and Availability > FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

The U.S. Food and Drug Administration (FDA) has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.

It’s strange to read this acknowledgment of “harms” from forced tapers after three full years of seeing these “harms” implemented very deliberately as a consequence of the disastrous CDC opioid prescribing guideline.

While we continue to track this safety concern as part of our ongoing monitoring of risks associated with opioid pain medicines, we are requiring changes to the prescribing information for these medicines that are intended for use in the outpatient setting.

“We continue to track this safety concern” implies they’ve been doing this all along, which they have not. 

Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms. In turn, these symptoms can lead patients to seek other sources of opioid pain medicines, which may be confused with drug-seeking for abuse.

Health care professionals should not abruptly discontinue opioids in a patient who is physically dependent.

But they are.

This warning should be unnecessary because any doctor who claims ignorance of these factors is not educated well enough in human biology and pharmacology to practice medicine.

I doubt the FDA will have any method of enforcing this warning as it’s been happening all over the country. Perhaps its only use will be as a pushback against forced tapering.

When you and your patient have agreed to taper the dose of opioid analgesic,…

They clearly state that tapers must be agreed to by the patient, “you and your patient have agreed to taper”, but I wonder how that will be implemented. After seeing how quickly many doctors abandoned patients who take opioids, I doubt many will rush back to serve us.

…consider a variety of factors, including

• the dose of the drug,
• the duration of treatment,
• the type of pain being treated, and
• the physical and psychological attributes of the patient

I’m thrilled to see them differentiate our pain issues and treatments instead of lumping all chronic pain together and assuming it’s a monolithic entity.

But we’ll have to see if and how the DEA will change it’s drug-war enforcement policies because that’s what doctors are afraid of. They fear the DEA with its unchecked powers much more than harming their patients.

No standard opioid tapering schedule exists that is suitable for all patients.

This is also stated in the CDC guideline, but doctors are afraid of anti-opioid activists, politicians, regulators, and especially the DEA who are using the arbitrary numbers mentioned in the CDC guideline as generic limits for everyone.

These are the same people who advocate for a “drug-free world” – an unrealistic (and cruel) fantasy.

Patients taking opioid pain medicines long-term should not suddenly stop taking your medicine without first discussing with your health care professional a plan for how to slowly decrease the dose of the opioid and continue to manage your pain

Contact your health care professional if you experience increased pain, withdrawal symptoms, changes in your mood, or thoughts of suicide.

But those very health care professionals are the ones who are coercing us to stop taking opioids in the first place!

The FDA is assuming that patients want to taper opioids and are asking doctors for help, but they have it backward: doctors are forcing patients to taper against their will and they are left desperate to escape their resulting pain.

We are trapped in the clutches of a healthcare system that’s willing to treat only a fraction of our pain, but we have no other recourse except dangerous street drugs.

We are continuing to monitor this safety concern and will update the public if we have new information.

“Continue to monitor”? If they had been monitoring or if the CDC tracked patient outcomes (which is said it would in the guidelines), some government agency would have been collecting data on the outcomes of their disastrous guideline.

Instead, all government actors have remained stubbornly silent since the CDC guideline was released in March 2016. For three very long years, they refused to look at what was and is still happening to pain patients.

Let’s hope this is only the first sign of awakening, and that more federal and state agencies will question the efficacy of current policies, start tracking patient outcomes, and adjusting their policies accordingly.

I have to wonder if it isn’t unrealistic to expect such rational behavior from our government.