Drugs

Judge Issues Restraining Order Against Covid-19 Product

A southern Florida federal judge has entered an emergency temporary restraining order and a preliminary injunction against Genesis II Church of Health and Healing (Genesis) and four individuals, requiring them to immediately stop distributing “Miracle Mineral Solution” (MMS), an unapproved and potentially harmful treatment offered for sale to treat coronavirus and other diseases.

“It is vital that sellers of drug products comply with the FD&C Act and do not sell products with false and misleading claims, especially to treat Covid-19 and other debilitating diseases, such as autism and Alzheimer's Disease,” FDA commissioner Stephen Hahn said in a release. “Despite a previous warning, the Genesis II Church of Healing has continued to actively place consumers at risk by peddling potentially dangerous and unapproved chlorine dioxide products.”

Previously, FDA and FTC jointly issued a Warning Letter to Genesis and have warned consumers numerous times over the past decade not to purchase or drink chlorine dioxide products such as MMS sold as medical treatments. In response to the Warning Letter, the “defendants made clear that they had no intention of taking corrective action and would continue to sell MMS in violation of the law,” FDA says. “This is especially concerning to the agency as the FDA has received reports of people experiencing serious adverse events, including respiratory failure, life-threatening low blood pressure, acute liver failure and QT prolongation after drinking certain chlorine dioxide products.”

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