Advocates Push for More Consistent Warnings on Glucocorticosteroid Drugs
New Haven, CT (Law Firm Newswire) September 21, 2011 - Glucocorticosteroids are often used to help patients battle serious infections, autoimmune diseases, cancer, and successfully go through organ transplant procedures. This group of name brand and generic medicines – marketed as prednisone, methylprednisolone and dexamethasone – are heavily used. In 2010, 25.5 million prescriptions for oral prednisone and 13.7 million prescriptions for methylprednisolone were written in the U.S.
Yet the public advocacy group Public Citizen and a prominent University of Michigan neuro-ophthalmologist say drug manufacturers are not including enough information about potential risks, precautions, and warnings in regards to glucocorticosteroids’ adverse effects. Their concern is that these drug labels are not warning patients that they could have impaired vision after taking the medicine. Central serous chorioretinopathy is a disease where fluid accumulates under the retina, and causes it to detach from the inner lining of the eye. The group found that 87 percent of glucocorticosteroid drug labels did not contain a warning about this adverse reaction and doctors did not have awareness of this complication.
“This goes to show you that just because a drug is approved by the FDA does not mean it is necessarily safe,” said Connecticut pharmaceutical liability lawyer Michael A. Stratton, of Stratton Faxon Law Firm. “Manufacturers have an obligation to provide ample warnings and possible side effects of their medicines.”
In a petition to the FDA, neuro-ophthalmologist Jonathan D. Trobe and Public Citizen called on the FDA to also require labels to have a warning about the “activation of latent infections due to special pathogens and a precaution about the possible development of Kaposi’s sarcoma.” Central serous chorioretinopathy and latent infections can cause objects to appear distorted. Sometimes this is a rare occurrence, but in other patients recurrent episodes can cause retinal injury and more permanent vision loss.
“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.
Stratton Faxon champions their clients’ rights to seek maximum compensation when a manufacturer or health care professional has left them with serious, life-altering injuries. They are one of the top three plaintiff personal injury law firms in the state and recipients of the Connecticut and New England Super Lawyers six years in a row. They are revered for taking on the most difficult and serious Connecticut personal injury and pharmaceutical liability cases and bringing them before juries. To learn more, visit the Connecticut personal injury law firm at http://www.strattonfaxon.com.
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