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Steroid drugs need stronger warnings, health group says
July 26--STEROID DRUGS SUCH AS PREDNISONE -- taken by 25.5 million Americans for arthritis, cancer, transplants and other conditions -- need stronger consumer warnings about a rare, but possibly irreversible vision impairment, a University of Michigan eye doctor and the consumer Public Citizen organization said today in a federal petition for stronger warning labels on the drugs.
The problem, chorioretinopathy, which causes distortion in vision, is not well known to doctors, UM's Jonathan Trobe said.
Given the number of people who take the drugs, "it's useful to know that a lot of visual complications are associated with steroids and if people develop a problem they should see an eye care specialist," said Trobe, professor of ophthalmology and neurology at U-M.
Trobe joined the non-profit Washington D.C. organization calling for stronger and more consistent warnings about the drugs.
Known generically as glucocorticosteriods, the medicines have been on the market for decades. Only two manufacturers of more than a dozen list the complication on drug labels as a potential side effect, said Dr. Michael Carome, deputy director of Public Citizen's Health Research Group, a Washington D.C. non-profit organization. The problem may go away on its own but can come back and lead to permanent visual loss, particularly in the center of the eye, Carome said. There are no large studies of the problem, only case reports describing occasional patient stories, he said.
The federal Food and Drug Administration lists petitions on its Web site, www.regulations.gov, typically within a few weeks after a petition is filed, and invites the public to comment on the proposal. The Public Citizen Web site, www.citizen.org, has copies of the petition.
Trobe said patients who took the drugs but did not develop eye problems are unlikely to be at risk of developing them now.
A spokesman for the Generic Pharmaceutical Association, a Washington, D.C. trade organization representing generic manufacturers, said the group was "we still reviewing it and don't have a comment" on the petition.
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