Strongest FDA Warnings Out on Opioid, Benzodiazapine Risks

Posted by Martin Jensen, Volunteer Mentor @predictable, Nov 2, 2016

The Food and Drug Administration (FDA) has issued its strongest warnings that prescription opioids and benzodiazapines pose major risks to users, especially if they are taken together or in combination with alcohol.

In a notice published at http://www.fda.gov/Drugs/DrugSafety/ucm518473.htm, the FDA told health care professionals to stop prescribing opioid cough medicines for patients taking benzodiazapines -- or other depressants of the Central Nervous System (CNS) including alcohol. They should prescribe opioids for pain only when other treatment options are inadequate.

Opioids — such as codeine, hydrocodone (HYSLINGA, NORCO, ZOHYDRO) and oxycodone (OXYCONTIN) — are widely prescribed for pain and cough. Benzodiazepines — such as diazepam (VALIUM) and alprazolam (XANAX) — are often used for anxiety, insomnia, seizures, and sleep problems.

Combinations of these drugs can cause extreme sleepiness, slowed or difficult breathing, coma, and death, the FDA said. Get details at the web site, and be sure to scroll down and click up several additional pages which explain the risks and list the dozens of opioids and benzodiazapines on the market.

The FDA said it now requires black-box warnings -- its strongest warnings -- on the dangers of combining opioid pain medications with benzodiazepines. Public Citizen’s Health Research Group lists most opioids as "Limited Use," noting that they are overprescribed and can be addictive. They list most benzodiazepines as "Do Not Use," with the exception of alprazolam, which is Do Not Use except for panic disorder.

Interested in more discussions like this? Go to the Chronic Pain Support Group.

Martin Jensen, Volunteer Mentor | @predictable | Feb 26, 2018

In reply to @galady "Well, isn't that wonderful for me. I'm 72 with insurable pain disease. What am I supposed..." + (show)

As I understand it, the FDA advice is a warning, not a requirement or prohibition. Does that mean patients using the double-barrel medications can work out a response with their doctor? And if not, get a second opinion from another doctor? I think so. Will that work for you @galady ?

Gary, Alumni Mentor | @gman007 | Feb 26, 2018

In reply to @jimhd "I started taking Klonopin in January of 2006, at 1mg, for anxiety disorder. I was taking..." + (show)

@jimhd

I started taking Klonopin in January of 2006, at 1mg, for anxiety disorder. I was taking 450mg of Wellbutrin already. This was before peripheral neuropathy entered my life.

The first few years with neuropathy I didn't need any medication, but around three years ago, I began experiencing increasing pain in my feet. I tried every medication for neuropathy, and then the neurologist recommended seeing a pain specialist. He took me through a bunch of meds that are off label for neuropathy, but are known to help some people. Nothing was helping. In the meantime, my pcp had me start taking morphine sulfate contin, and over the course of a year or so, I gradually worked up to 30mg tid. I finally found relief from the pain.

Last year I had a spinal cord stimulator implant in June and it reduced my pain by 80%. After that, I weaned off the morphine, to figure out if it was the morphine or Cymbalta that was helping my residual pain. After being off the morphine for 2-3 weeks, I knew that it was the medication I needed. I later weaned off the Cymbalta and didn't observe any effect, positive or negative, on the neuropathy pain. When I restarted morphine, I was able to get relief at 15mg bid.

Over the past couple of months, I've been having increased pain, and the stimulator is adjusted to its strongest setting, so I plan to ask my doctor to increase the morphine, beginning with adding a third pill at lunch. That's still a relatively low dose.

Back to the Klonopin, I tried several years ago to wean off it and went from 1mg to .75mg. After a few sleepless nights, I gave up. One of my doctors recommended that I continue taking it because it keeps me from acting out my dreams, specifically leg motion - read that, kicking my wife. She doesn't want me to stop taking the Klonopin. But, as I said, it's only 1mg.

My takeaway from the opioid/benzodiazepine discussion is that I will continue taking them because morphine is my last resort. I've run out of options. I think that my BIPAP will lower the risk of stopping breathing.

Jim

Jump to this post

@galady, I have been in exactly the same place in terms of not feeling like I was taking a huge risk with the shape I was in. I am sorry that you are not getting relief and wish the best for you and your situation.

stfnwtl89 | @stfnwtl89 | Feb 26, 2018

In reply to @jimhd "I started taking Klonopin in January of 2006, at 1mg, for anxiety disorder. I was taking..." + (show)

@jimhd

I started taking Klonopin in January of 2006, at 1mg, for anxiety disorder. I was taking 450mg of Wellbutrin already. This was before peripheral neuropathy entered my life.

Jim

Jump to this post

My mom is in the same type of pain, and tells me regularly she is at the point she just doesn't care anymore. If it wasn't for the care of my father I truly believe she would give up and had rather be with our heavenly father than here on earth in the pain she has to withstand daily. I pray for those who are in this type of agony and hope each day something or someone can find a medication or procedure to help those suffering. I am looking for answers as you are and there does not seem to be any easy or good ones...

Jim, Volunteer Mentor | @jimhd | Feb 26, 2018

In reply to @galady "Well, isn't that wonderful for me. I'm 72 with insurable pain disease. What am I supposed..." + (show)

@predictable

It may be a warning and not a requirement, but doctors and clinics, including the one I go to, are cutting way back on the maximum dosage doctors are allowed to prescribe. My pcp told me that if I need more than 100mg of my meds combined, I would have to have a clearance from my pain specialist because of the new restrictions placed on him.

Jim

stfnwtl89 | @stfnwtl89 | Feb 26, 2018

Yes, the PCP doesn't even prescribe meds to my family member, all meds go through pain clinic and they have reduced meds signaficantly. My question is what is the goal of a pain mgt. clinic? Are they supposed manage pain or has the focus now switched to reduction of pain medication? Are they all entered for a drawing at the end of the year for a trip to a tropical destination based on the # of people they are documenting as having a reduction of medication? The pcp tells one thing and the pain clinic dr. says something else. What is the truth. When in chronic pain and somebody says the pain is unbearable and quite frankly would rather just give up than live in pain what good have you served them by removing a potentially harmful medication from them? I get you have people who drug shop but there are millions of other people who do not.

Martin Jensen, Volunteer Mentor | @predictable | Feb 26, 2018

In reply to @galady "Well, isn't that wonderful for me. I'm 72 with insurable pain disease. What am I supposed..." + (show)

@jimhd, can you ask your PCP whose restrictions he's dealing with? Is the FDA warning becoming another authority's requirement? Is the Justice Department involved? Is the CMS (Medicare and Medicaid) threatening to not pay on the basis of dosage or combinations? Is this a case of a state Medicaid agency or program placing restrictions? Are insurance companies threatening to not pay? If so, how do they know about dosage? Which companies? Are there any organizations gearing up to resist the dosage and combination limitations?

19lin | @19lin | Feb 26, 2018

@stfnwtl89 I liked what you said. I have maintained for a long time that some objective measure of individual pain must be developed so that much of the problems with pain medication can be resolved. To the best of my knowledge, there is little research going on in this area and even less funding being provided for it. 19lin

Jim, Volunteer Mentor | @jimhd | Feb 26, 2018

In reply to @galady "Well, isn't that wonderful for me. I'm 72 with insurable pain disease. What am I supposed..." + (show)

@predictable

The clinic my doctor works with is under the hospital umbrella. The dosage decree came from them. I don't know how the decision was made by them. I might see if I can find out.

Jim

galady | @galady | Feb 27, 2018

In reply to @galady "Well, isn't that wonderful for me. I'm 72 with insurable pain disease. What am I supposed..." + (show)

I believe it is requiem ent of the DEA. These Dr's are scared to death of the DEA. they can close down, arrest, or lose their licence. I'm on my 4th opinion, but the DEA can red flag me for "doctor shopping". It's bad.