Tag Archives: FDA

Opioid taper as an institutional mandate

Opioid discontinuation as an institutional mandate: Questions and answers on why we wrote to the Centers for Disease Control and Prevention: Substance Abuse: Vol 40, No 1 – Stefan Kertesz, MD – May 2019

This article explains what the HP3 group wanted to accomplish with their letter “protesting” the CDC guideline. It looks like it worked!

On March 6, 2019, a self-designated committee (Health Professionals for Patients in Pain, HP3, a group that is not incorporated and accepts no contributions) sent a public letter to the Centers for Disease Control and Prevention (CDC), urging the agency to address the widespread misapplication of its 2016 guideline on prescribing opioids.

318 health care professionals and three former directors of the White House Office of National Drug Control Policy (“Drug Czars”) signed the letter, as did the parent organization for Substance Abuse, the Association for Multidisciplinary Education and Research on Substance use and Addiction.   Continue reading

FDA warns against sudden discontinuation of opioids

FDA identifies sudden discontinuation of opioid pain medicinesfda.gov – Apr 2019

I don’t know how I missed this until now. If your doctor is trying to force you into a taper, you can let them know that the FDA warns against taking opioids away from pain patients without a medical reason and then only in a carefully planned extremely gradual taper.

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.    Continue reading

CDC Joins FDA in Decrying ‘Mandated Dose Reduction’

Seeking to Clarify Its Opioid Prescribing Guidelines, CDC Joins FDA in Decrying ‘Mandated or Abrupt Dose Reduction’– by Jacob Sullum – Apr 2019

Acknowledging the suffering caused by “misinterpretation” of the opioid prescribing guidelines it published in 2016, the U.S. Centers for Disease Control and Prevention (CDC) yesterday sought to clarify that it never recommended imposing involuntary dose reductions on chronic pain patients.

In a letter to physicians who had objected to that widespread practice, CDC Director Robert Redfield emphasized that his agency “does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm.”

The CDC may not “endorse” them, but they deliberately looked the other way for 3 years while this was happening.  Continue reading

Too Little, Too Late: Feds Backtrack on Opioid Discontinuation

Too Little, Too Late: US Government Backtracks on Opioid Discontinuation

Thousands of patients have been dispassionately forced into tapering their opioids, often inappropriately, due to fear from regulatory agencies following initiation of the 2016 CDC Guideline on Prescribing Opioids for Chronic Pain.

In addition to unnecessary suffering, this has resulted in opioid withdrawal due to due either rapid or misguided or inexperienced taper regimens.

The sad irony here is that three years later, the FDA is saying exactly what nationally recognized pain experts have been saying all along.   Continue reading

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.  Continue reading

MedWatch Voluntary Reporting Form

MedWatch Voluntary Reporting Form – the official FDA site for complaints

Another patient described on Pharmacist Steve’s blog how to word complaints about sudden, medically unjustified, reduction in opioid medication:

Here’s the blurb I came up with:

Withdrawal symptoms, and other adverse reactions, are considered a serious safety problem with medication, especially when this is happening as a result of a doctor abruptly discontinuing or inappropriately tapering your drug treatment in a way directed against in the medicine’s US FDA approved prescribing information.   Continue reading

How the Fed Used Opioids as Scapegoat

Games without Frontiers: How the Fed Used Opioids as Scapegoat & Diversion for the Nation’s True Crises – by Matthew Giarmo, Ph.D. – Sept 2018

Here’s a guy who lays it out as he sees it, remarkably similar to the view of pain patients. This could be because he took time off to take care of a family member with cancer – he saw firsthand the full destructive force of their pain.

EXECUTIVE SUMMARY

  • The problem is not opioids. It’s heroin.
  • The problem is not painkillers. It’s pain.
  • The problem is not prescription. It’s diversion.

To all those sanctimonious crusaders, self-aggrandizing careerists, and shameless opportunists looking for a piece of the opioid pie, I say that you are more addicted to the opioid crisis than we are to opioids.  Continue reading

Report adverse or no medication effects to the FDA

MedWatch Voluntary Reporting Form – for reporting adverse drug effects to the FDA

Perhaps the FDA doesn’t know how ineffective “alternative” non-opioid drugs are for pain because no one has told them. You can download a form from this site (link above) to report your experiences.

Use the MedWatch form to report adverse events that you observe or suspect for human medical products,including

  • serious drug side effects,
  • product use/medication error,
  • product quality problems, and
  • therapeutic failures

It’s this last category that presents our opportunity for action. We could report the “therapeutic failures” and awful side-effects of non-opioid medicaitons like Lyrica, gabapentin, or antidepressants for pain. Continue reading

Addiction crisis shifts to the next drugs

The previous post and these three articles, all from this year (2018), highlight the absurdity of our drug-war against prescription opioids. Each article finds that drugs other than prescription opioids are becoming increasingly available and more often abused.

As the mushrooming crisis of addiction moves on, the CDC is still busy counting pain patients’ pills and meddling in medical practice.

While America wages war on opioids, meth makes its comeback – CNN – By Drew Kann, CNN – September 28, 2018

For Capt. Mark Wollmershauser Jr. and the Tulsa Police Department, the late-2000s and early 2010s were an extremely dangerous time. In Oklahoma, a state that is no stranger to the scourge of methamphetamine addiction, those years were the heyday of the “shake and bake” method — a rudimentary way of making meth using just cold medicine, some toxic chemicals and an empty two-liter bottle.  Continue reading

FDA seeking ‘right balance’ for opioid regulations

FDA seeking ‘right balance’ in regulating opioid prescriptions | BioPharma Dive By Rebecca Pifer Published July 10, 2018

Food and Drug Administration chief Scott Gottlieb reaffirmed in a statement Monday the agency’s commitment to finding the “right balance” between reducing the U.S. rate of opioid addiction and providing access to legitimate patients, for whom these medications can be lifesaving.

He had strong words for practitioners regarding their role in helping spur the opioid epidemic. “The roots of this crisis are embedded in the practice of medicine, and prescribing practices that were at times too cavalier,” Gottlieb said.

No, they are not. The “roots” of this crisis are the skyrocketing rates of addiction. And the problem is expanding much farther than just opioids, with use of and overdoses from drugs like meth and cocaine rising.  Continue reading