FDA Warns About Unapproved Drugs in Pain Pumps

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is warning patients and healthcare providers about serious complications that can occur when using medications not approved for use with intrathecal pain pumps. The agency says it has received “numerous reports” of pump failures, dosing errors, infections and other safety issues.

Pain pumps are implanted under the skin, usually near the abdomen, and deliver medication through a catheter directly into spinal fluid to treat chronic pain. They require a healthcare provider to periodically refill the pump with pain medication. The pumps are generally used as a last resort for patients whose pain is not adequately managed by oral medication, surgery and other treatments.

Currently, there are only two FDA-approved medications for intrathecal pain pumps; Infumorph (a morphine sulfate solution) and Prialt (a sterile solution).

Drugs approved for intrathecal administration must meet additional safety standards because the spinal cord and brain tissue are highly sensitive to preservatives or infectious organisms such as bacteria or viruses.

pain pump.png

The FDA has found that some patients are being treated with medications that are not approved for pain pumps – including hydromorphone, bupivacaine, fentanyl and clonidine – as well as compounded medications.

One reason patients may not be using Infumorph is that it is currently listed on the FDA’s drug shortage list. Some patients may also believe the unapproved drugs are more effective, although the FDA says they are still too risky.  

“While medical devices, such as implanted pumps that deliver medication directly into the spinal fluid, have the potential to play an important role in treating pain, their use must be judicious and their instructions for use must be carefully followed. This is especially true when it comes to implantable pumps that deliver analgesic medicine directly into the nervous system,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

The FDA says the failure rate of the pumps more than doubles when unapproved medications are used. Some drugs may contain preservatives that can damage the pump tubing or cause corrosion. Dosing errors can also occur because the software on pain pumps is only designed to calibrate doses with approved medications.

“FDA acknowledges that some patients being treated for pain may not be adequately managed by medicines approved for use with these pumps; however, the use of medicines not approved with the implanted pumps are associated with additional risks,” the agency said. “The FDA recommends that health care providers review the implanted pump labeling to identify the medicines and medicine concentrations approved for use with the specific pump.”

Patients and providers who experience an adverse event with an implanted pump or suspect one is having problems are encouraged to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Opioid Medication Made My Chronic Pain Worse

By Robert Gripp, Guest Columnist

After 18 years of largely untreatable chronic pain, I found myself with an intrathecal pain pump delivering huge quantities of fentanyl to my spine every day. And I was still in debilitating pain.

I was on my second pain pump (they have to be replaced about every seven years) when the pump began to act up and I started into withdrawal. I immediately saw my new doctor, who had taken over my care when my original doctor retired at age 75.

He had the pump manufacturer’s representative there to help figure out what was going on. It turned out the pump was unreliable, and the doctor recommended it be powered off. I was sent home with minimal meds to detox.

Detox was the absolute most horrible experience I have ever encountered, but at the end I was virtually pain free. The reason was that I had developed opioid-induced hyperalgesia (OIH), which increased my sensitivity to pain.



OIH is a well-documented syndrome, but my doctors had missed the hallmark signs of it, which are changes in the location and characteristics of your pain, as well as little or no relief from pain when the dosage is increased.

I am now 63 years old and have a new life. I have some pain, but nothing that is not well controlled with little or no opioids.

I do not believe that all patients who take high doses of opioids experience hyperalgesia, nor does the literature support any such conclusion. My purpose is to caution anyone on high doses for an extended period. If it is not helping you or your pain is worse after increasing the dosage, you should be aware of this condition and its potential.

Overzealous lawmakers and over-reaching insurance companies who want to limit opioids due to the addiction crisis don’t have a clue. Limiting opioids is making it harder for pain patients who really need them. But my experience is also something that needs to be better understood and the condition of hyperalgesia needs to be more publicized.

Our tendency is to believe more pain medicine is better when our pain worsens. I have to wonder how many people are out there in tremendous pain being caused by the very medicine given them to abate it. I am afraid it is way too many.

I hope my story helps someone get a new life, without having to stumble onto it as I did.


Robert Gripp lives in Texas.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.