Drugs

FDA Hides Product Names in Serious CAERS Reports: Survey

FDA has been redacting the dietary supplement product names in many serious reports of adverse events voluntarily submitted to the Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) database. Consumer Reports says the agency often puts “Exemption 4” in the database column where the product name would go, referring to what it says is an “obscure regulation” requiring FDA to redact the product name when an adverse event report is voluntarily submitted to CAERS.

However, the magazine says that when reports involve “serious” events such as hospitalizations or deaths, the product name is supposed to remain in the listing. But FDA has not been following that protocol, it says.

Consumer Reports says that among more than 1,300 products for supplements labeled Exemption 4 in CAERS, more than one-third involved deaths or hospitalizations.

The story says an agency spokesperson acknowledged that some reports were incorrectly labeled Exemption 4 “due to technical issues.” The spokesperson said a database update is expected in the next two months.

The article quotes Rep. Rosa DeLauro (D-CT) as saying it is “troubling” to learn that FDA has withheld critical information on adverse event reports. “Because FDA does not review dietary supplements for safety and effectiveness before they go on the market,” DeLauro said, “any information on serious adverse events must be available so that consumers can protect themselves and their families from potentially harmful products. FDA must resolve this immediately and remove barriers to this information.”

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