FDA Should Require Drug’s Manufacturer to Warn About Serious Adverse Effects

July 26, 2011  

FDA Should Require Drug’s Manufacturer to Warn About Serious Adverse Effects

Prednisone and Other Glucocorticosteroids Can Cause Dangerous Eye Disorder

WASHINGTON, D.C. – The Food and Drug Administration (FDA) 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, Public Citizen and an eminent neuro-ophthalmologist from the University of Michigan said in a petition sent today to the agency.

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 also cause many 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 percent of labels included a warning about this eye condition.

Dr. 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.

Public Citizen also noted many other significant discrepancies between the labels of these steroid drugs in the information regarding risks and precautions. For example, some of the labels for these drugs described the risks of serious fungal and parasitic infections, whereas others did not. Therefore, the FDA should review labels for all glucocorticosteroids and, as appropriate, require additional label changes to ensure that important information relating to the products’ safety is included on a consistent basis, Public Citizen said in the petition.

“Since these drugs share similar mechanisms of action and risk profiles, it is important that the labels for these drugs communicate consistent information regarding their use and safety to healthcare providers and consumers,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group.

Patients may notice central serous chorioretinopathy by its vision-altering characteristics, like objects appearing distorted. While these episodes usually go away, the condition can come back, and recurrent episodes can lead to extensive retinal injury and permanent visual loss, Public Citizen said.

Glucocorticosteroids are widely prescribed in the United States. In 2010, there were 25.5 million prescriptions for oral prednisone and 13.7 million prescriptions for methylprednisolone tablets in the country.

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Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org.