Vision loss. Stroke. Paralysis. Death. These are among the rare but serious outcomes associated with receiving the injection of corticosteroids into the epidural space of the spine.
Don’t take it from us. The U.S. Food and Drug Administration issued that warning April 23, targeting the injection of numerous corticosteroids, including methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone. Going a step further, the FDA has required that such a warning be added to the labels of injectable corticosteroids.
The injections are a part of the treatment for neck and back pain or shooting pain in the extremities. They are used to reduce swelling and inflammation as well.
The FDA wrote, “Injecting corticosteroids into the epidural space of the spine has been a widespread practice for many decades; however, the effectiveness and safety of the drugs for this use have not been established, and FDA has not approved corticosteroids for such use.”
FDA officials learned about the neurological risks of epidural corticosteroid injections from physicians. Prompted by a segment of the medical profession, the agency examined data from its own database of adverse event reports. Findings published in medical research articles were the icing on the cake.
Federal regulators plan to bring experts together later in 2014 to discuss the risks and perhaps to make recommendations.
From a legal standpoint, two issues are whether the risks were unreasonable and whether the makers of these injectable drugs either knew or should have known of the severity of the consequences. There are other factors that determine whether someone injured by the epidural injection of corticosteroids may be entitled to compensation.
But these are legal analyses best left to attorneys skilled at handling product liability lawsuits against large pharmaceutical corporations. Reich & Binstock has been providing quality legal representation in this regard for 30 years and has a laudable track record to prove it.
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