FDA Warns about Epidurals

Patients who suffered spinal cord injuries during epidural steroid injections are cheering a decision by the Food and Drug Administration to require drug makers to put warning labels on injectable corticosteroids.

Injecting steroids into the epidural space of the spine to relieve pain caused by childbirth or back problems has been a widespread practice for decades. Less commonly known is the damage it can cause to the spine if the needle is inserted in the wrong place.

“Injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death,” the FDA said in a statement. “Patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments.”

Doctors prepare to make anesthesia

Epidural steroid injections are increasingly being used to treat back pain of all kinds, with nearly 9 million spinal injections annually in the U.S.

The FDA said it began investigating the safety of epidural steroid injections “when we became aware of medical professionals’ concerns” and after reviewing its own adverse event database.

Patients injured by the procedure have been warning the agency for years about the “dark side” of epidurals.

“I am relieved and hopeful that things are on the right track, but there is still much more that needs to be done to stop these ineffective, harmful pain treatments from maiming and crippling people and ruining their lives,” said Dawn Gonzalez, whose spine was permanently damaged by an epidural during child birth. She now suffers from arachnoiditis and is an advocate for Arachnoiditis Society for Awareness and Prevention (ASAP).

“They need to do something to warn specifically about arachnoiditis, and do something to help those of us that have already been damaged by these procedures. They will find that these instances are not in fact rare like they say, but are in epidemic proportions relative to the number of these injections that have been given over the last 10 or so years.”

Arachnoiditis is an inflammation in the arachnoid membrane that surrounds the spinal cord. If the membrane is punctured by a needle during an epidural, it can trigger inflammation that produces scar tissue that adheres to the nerves in the spinal cord. Eventually the nerves become completely encased in scar tissue, causing severe chronic pain and other neurological problems.

Some in the arachnoiditis community wish the FDA would go further with its warning.

“We are upset that there is no mention of the risk of arachnoiditis,” said Terri Anderson, who developed arachnoiditis after receiving about 20 epidural steroid injections for a ruptured disc in her back.

Anderson has been lobbying the FDA to require warning labels for corticosteroids such as Pfizer’s Depo-Medrol (Methylprednisolone).

“This drug is now banned for epidural use in Australia and  New Zealand.  It is time for the FDA to protect public health and make these same label changes in the U.S. The risk of serious adverse events is not rare and arachnoiditis is grossly misdiagnosed and under-reported to the FDA for obvious reasons (fear of reprisal and legal liability),” Anderson said in an email to National Pain Report.

In addition to arachnoiditis, several recent studies have found that epidural steroid injections raise the risk of spinal fractures and often do little to control back pain.

To raise awareness of the safety risks of epidurals, the FDA has convened a panel of experts to help define techniques for the injections which would reduce preventable harm. An advisory committee will also be formed later this year to discuss the benefits and risks of epidural injections, and whether further FDA action is needed.

Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone. The safety issue is unrelated to the contamination of compounded corticosteroids in 2012 that led to an outbreak of fungal meningitis that killed dozens of patients and sickened hundreds. Most received the injections to treat their back pain.

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