FDA Warns About Dangers of Epidural Steroid Injections for Back Pain

by M G Rana, MD.

Epidural injections have been used for low back problems since 1952 and still they are an important part of non-surgical treatment for sciatica and low back pain. They are common treatment options for many types of low back pain. Their main goal in pain relief but sometimes injection alone is not sufficient for pain relief. Then it may be combined with other forms of comprehensive rehabilitation programs.

The food and drug administration has just recently announced about a serious issue named under article “Medwatch Alert”, the information in this article has seriously warned about the dangers of epidural steroid injections for neck pain or back pain. They told that this can be extremely dangerous and can lead to serious side effects like loss of vision, stroke, and paralysis and may cause even death. Between the bony structure of spine and spinal cord, there is a space known as epidural space.

Mainly corticosteroids are been in use for decades to reduce swelling or inflammation in the epidural space of the spine. Although it is in use for decades but still its effectiveness and safety is the topic yet to be discovered. FDA has not approved its safety. Research was started after some doctor’s fear about serious neurological side effects after its use.

Patients should discuss about the dangers of using this treatment for spine with their doctors along with other treatment options as well. In order to raise awareness in the medical community about the possible harms of corticosteroid injection a panel was made by FDA containing some pain experts as well. They want to discover more about techniques for such injections that prevent the possible harms.

Their recommendations are still not finalized. They will be issued when finalized. Methylprednisolone, hydrocortisone, betamethasone and dexamethasone are some injectable corticosteroids. Medwatch alert is not enough to highlight the possible risks of these corticosteroids. We also require the addition of warning instructions on the label of these drugs. This new warning will be an important reminder for the doctors that injecting such corticosteroids outside the spine into the epidural space is dangerous. But this warning is insufficient to highlight all the possible side effects.

Some facts about corticosteroids

  • >>Corticosteroids is normally a class of drugs to reduce inflammation and swelling.
  • >>They are not approved by FDA for injecting into the spine.
  • >>Report any side effects from epidural corticosteroid injections to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.

Immediately seek for medical attention if you notice any one of the side effects like tingling sensations in the arms, sudden weakness or numbness in your face, dizziness or severe headache. Capolongo wants that FDA should give details about the possible side effects of corticosteroid injection instead of just stating that they must not do it.

Dennis Capolongo belongs to the group EDNC that has been complaining for years about the possible side effects of these drugs. They labeled FDA’s new warning “bittersweet” because it did not go further. It is good news that FDA is actively doing research on the issue and we are sure more information will be conveyed to us.

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Reference:

  • FDA Drug Safety Communication: FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for pain via FDA
  • FDA Warns About Dangers of Epidural Steroid Injections for Back Pain by Julia Nelson via Women support for Fibromyalgia

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2 comments

FDA Warns About Dangers of Epidural Steroid Injections for Back Pain - Women With Fibromyalgia December 11, 2019 - 2:34 am

[…] Food and Drug Administration has just issued what’s called a “Medwatch Alert” warning that Epidural steroid injections or “ESIs” for back and neck pain can be extremely dangerous. The alert says: “Injection of […]

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FDA Warns About Dangers of Epidural Steroid Injections for Back Pain | Chronicoid February 27, 2020 - 9:12 am

[…] Drug Administration has just issued what’s called a “Medwatch Alert” warning that Epidural steroid injections or “ESIs” for back and neck pain can be extremely dangerous. The alert says: “Injection of […]

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