Drugs

After 12+ Years, FDA Approves Steroid Label Changes

After more than 12 years, FDA has approved a Public Citizen 8/7/2011 petition request for safety labeling changes for glucocorticosteroids administered orally and by injection. In its 2/8 response, the agency denied other petition requests.

“In particular,” the response says, “we partially grant the request that FDA require specific warnings and precautions regarding latent infections due to special pathogens and Kaposi’s sarcoma in the labeling of corticosteroid products, by requiring them in oral and injectable corticosteroid products. To the extent your petition requests these labeling changes with respect to other routes of administration … that request is denied.”

FDA also denies these additional elements in the petition:

require that prednisone and all glucocorticosteroids currently on the market in the U.S. include central serous chorioretinopathy as an adverse reaction in their drug labeling; and
review the labeling of all glucocorticosteroids and as appropriate require additional label changes to ensure that other important information regarding the use and safety of these medications is presented consistently across all labels.

Contacted by FDA Webview, Public Citizen Health Research Group director Robert Steinbrook said, “It is ridiculous for FDA, which is a public health agency, to take 12-and-a-half years to respond to a citizen petition to improve safety labeling for widely used medications. Nonetheless, Public Citizen is glad that the agency has partially granted our requests and is requiring safety label changes for glucocorticosteroids administered orally and by injection.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome