Drugs

FDA Requires New Gadolinium Agent Warning

FDA is requiring a new class Warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for MRIs. The Warning concerns retention of gadolinium in patients’ bodies, including the brain, for months to years after receiving the drugs. “Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and we have concluded that the benefit of all approved GBCAs continues to outweigh any potential risks,” the agency says in an updated safety communication.

An initial safety communication on the subject was issued 5/22/17. FDA says that after additional review and consultation with the Medical Imaging Drugs Advisory Committee, it decided to require several actions to alert healthcare professionals and patients about gadolinium retention after an MRI using a GBCA and actions that can help minimize problems, including a new Medication Guide that patients will be asked to read before receiving a GBCA. And FDA says it is asking manufacturers of GBCAs to conduct human and animal studies to further assess the contrast agents’ safety.

“To date,” FDA says, “the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis that occurs in a small subgroup of patients with pre-existing kidney failure. We have also received reports of adverse events involving multiple organ systems in patients with normal kidney function. A causal association between these adverse events and gadolinium retention could not be established. We are continuing to assess the health effects of gadolinium retention in the body and will update the public when new information becomes available.”

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

Read more

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