US FDA should call on glucocortcosteroids drugmakers to warn about serious AEs, says Public Citizen

The US Food and Drug Administration should require manufacturers of all glucocorticosteroid drugs, such as prednisone, methylprednisolone and dexamethasone, to revise their labels to warn about a rare, but serious adverse effect that could leave patients with impaired vision, said consumer advocacy group Public Citizen and an eminent neuro-ophthalmologist from the University of Michigan, USA.

Glucocorticosteroid drugs are synthetic steroids used to treat a wide range of diseases, including inflammatory and autoimmune diseases (such as asthma and rheumatoid arthritis) and certain types of cancer, and to prevent rejection of transplanted organs. But these drugs may also cause serious adverse effects, including central serous chorioretinopathy, a rare disease in which fluid accumulates under the retina, causing it to detach from the inner lining of the eye. In Public Citizen’s review of prednisone and other related steroid drugs, only 13% of labels included a warning about this eye condition.

Jonathan Trobe, professor of ophthalmology and neurology at the University of Michigan School of Medicine, stated that “central serous retinopathy, a condition in which fluid accumulates and distorts the part of the retina necessary for fine (high acuity) vision, is a rare but sometimes irreversible complication of the use of glucocorticosteroids. This side effect is currently not well known to physicians. For that reason, it should be more prominently displayed as a warning on the labels of these drugs.” Dr Trobe is a co-petitioner with Public Citizen to require revisions to the labels of glucocorticosteroid drugs.