Drugs

FDA Reminder on Proper Transport Media

FDA is reminding laboratory staff to use transport media that are compatible with Covid-19 testing platforms and the processes used in their laboratory to process samples collected. “There is a risk of exposure to harmful cyanide gas, a by-product of a reaction between guanidine thiocyanate or similar chemicals and bleach (sodium hypochlorite), when certain transport media are used with an incompatible testing platform or laboratory process,” the reminder says. Guanidine thiocyanate is also referred to as guanidinium rhodanide, guanidinium thiocyanate, or guanidinium.

FDA says there are numerous transport media that contain guanidine thiocyanate or similar chemicals. “PrimeStore molecular transport media (MTM) (LH-1-02 and LH-1-03), Zymo DNA/RNA Shield, Spectrum Solutions Saliva Collection Device, and any other transport medium containing guanidine thiocyanate or similar chemicals, should not be used in a testing platform such as the Hologic Panther and Panther Fusion Systems that use bleach or in laboratories that use bleach as part of their normal laboratory processes,” it says. “When the bleach interacts with the guanidine thiocyanate or similar chemicals in the transport media, it produces cyanide gas.”

FDA acknowledges that there have been reports of potentially hazardous interactions, but no injuries have yet been reported on exposure to cyanide gas as a result of using incompatible media with testing platforms.

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