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FDA Should Protect Patients by Prioritizing Prompt Revisions of Safety Labeling for Drugs

WASHINGTON, D.C. — Earlier this month, the Food and Drug Administration (FDA) finally responded to a July 2011 petition from Public Citizen’s Health Research Group requesting added safety warnings on the labels of glucocorticosteroids including prednisone.

In its response, the FDA partially granted the requests by “requiring safety labeling changes with respect to glucocorticosteroids administered orally and by injection.” Specifically, the FDA required broader warnings about an increased risk of Kaposi’s sarcoma and the activation of latent infections due to special pathogens. Kaposi’s sarcoma is a cancer, typically with purple lesions, that can involve the skin, lymph nodes, lining of the mouth, nose, and throat, and other body tissues. Special pathogens are infectious agents, including those that are emerging or unusual, that may raise distinctive public health concerns.

 Dr. Robert Steinbrook, director of Public Citizen’s Health Research Group, released the following statement in response.

 “It is outrageous that the FDA, a public health agency, took 12-and-a-half years to respond to a citizen petition to improve safety labeling for widely used medications.

 Public Citizen petitioned the FDA in 2011 to improve safety labeling for prednisone and other glucocorticosteroids. Our petition was straightforward: minimal agency resources were needed to review the petition and provide a timely response. Instead, the agency dithered for more than a decade.

 Nonetheless, Public Citizen is glad that the FDA has partially granted our requests and is requiring safety label changes for glucocorticosteroids administered orally and by injection.

 Going forward, the FDA should protect patients by prioritizing the prompt response to requests for enhanced safety labeling of drugs and other medical products.”