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Epidural Corticosteroids get Updated Warning Labels

Filed April 24th, 2014 Laurie

The U.S. Food and Drug Administration (FDA) has ordered that all injectable corticosteroids must now carry a new warning label informing the public of the risks of severe adverse effects, including death, stroke, permanent blindness, and paralysis associated with epidural injections.

The new labels were prompted by the agency’s review of numerous reports of injuries in medical literature, as well as the FDA’s own adverse event database. Some of those injuries include death, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke, seizures, nerve injury, and brain edema, according to MedPageToday.com.

In the warning, obtained by MedPageToday.com, the FDA said that “many cases were temporally associated with the corticosteroid injections, with adverse events occurring within minutes to 48 hours after the corticosteroid injections.” Some neurologic diagnoses were confirmed using magnetic resonance imaging (MRI) or computed tomography scan (CT).

Unfortunately, according to the report, many patients did not recover from these reported adverse events, according to MedPageToday.com.

Health officials are urging healthcare providers to discuss these risks with patients before injecting them with corticosteroids, and to instruct patients to be hypervigilant about vision loss, numbness, tingling, severe headaches, or seizures, MedPageToday.com reported.

Corticosteroid injections are most often used to treat inflammation in small areas of the body, such as the knee, but can also be used to treat widespread problems. Bursitis, tendonitis, and osteoarthritis are all conditions that are frequently treated by corticosteroids, according to Medicinenet.com.

Corticosteroids can be extremely dangerous to patients suffering from diabetes, as the injections can elevate glucose levels. The shots can also make it difficult for patients with underlying medical conditions to fight infection, and they may actually cause some infections to worsen. Healthcare providers are cautious about using corticosteroids in diabetes and tend to avoid using them entirely in people with active infections, Medicinenet.com explained.

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