The FDA recently issued a warning regarding injectable steroid epidurals. New warning labels on these steroid drugs will now indicate that they may cause rare but fatal complications in some patients, sometimes within just minutes. Medical malpractice attorneys at Pintas & Mullins Law Firm highlight this newly-recognized risk and who may be most likely to suffer fatal complications.
Spinal injections of steroids are used for many reasons in the medical community despite lack of federal approval. It may be surprising to hear (it certainly surprised us) that corticosteroid injections into the epidural are not approved by the FDA, since the drugs have been used in this way for many decades throughout the U.S. The FDA asserts that it has not approved steroid injections in the epidural because it has not yet been proved the practice is safe and effective.
The potential side effects are largely neurological, and include:
• Stroke • Paralysis • Death
Steroids are often injected to treat neck or back pain that radiates to the arms and legs, and to reduce swelling or inflammation. The FDA launched an investigation into this practice after a large number of medical professionals started voicing concerns about the neurological side effects.
After it became clear there was a significant safety issue, the FDA started an official review of the agency’s Adverse Event Reporting System database and other medical literature. After this review, the agency decided to update all the warning labels of steroid injections on the life-threatening risks of injecting patients for pain.
To further raise awareness of this issue, the FDA’s Safe Use Initiative called together a panel of medical experts – including pain management experts – to help define the proper techniques for using steroid injections. This panel’s recommendations on reducing harm to patients will be released once they are finalized.
Later this year, the FDA also plans to convene an Advisory Committee meeting of even more experts, who will discuss the benefits and risks of epidural steroid injections. This committee will decide whether or not the agency needs to take even further action to prevent serious harm.
The following steroid drugs are commonly injected into the epidural (bottom area of the spine) to relieve pain:
• Betamethasone • Dexamethasone • Hydrocortizone •
Methylpredisolone • Triamcinolone
The onset of serious complications from these drugs can occur anywhere between a few minutes and 48 hours after injection. If these drugs names sound familiar, it is because some were associated with a meningitis outbreak in 2012 that killed dozens of patients and injured hundreds more.
Those steroids had been contaminated at specialty compounding pharmacies, which were at that time unregulated by the FDA. The fatal 2012 outbreak led to an increase in regulation and oversight, which is just now starting to be enforced throughout the country.
Dangerous drug lawyers at Pintas & Mullins Law Firm will continue to report on this issue as the FDA and other medical agencies release more information. If you or someone you love was seriously injured or killed from contaminated or improperly used steroid injections, contact our firm immediately. We have decades of experience fighting on behalf of injured patients and their families. Our legal consultations are always free, confidential, and available to injured victims nationwide.