FDA reviewed a sampling of cases from the FDA Adverse Event Reporting System (FAERS) database, as well as cases in the medical literature of serious neurologic adverse events associated with epidural corticosteroid injections. 2-16 Serious adverse events included death, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke, seizures, nerve injury, and brain edema. Many cases were temporally associated with the corticosteroid injections, with adverse events occurring within minutes to 48 hours after the corticosteroid injections. In some cases, diagnoses of neurologic adverse events were confirmed through magnetic resonance imaging or computed tomography scan. Many patients did not recover from these reported adverse events.
This information should not be used to decide whether or not to take Aclovate or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Aclovate. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
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