Drugs

FDA Safety Alert on Off-label Chloroquine

FDA has issued a MedWatch safety alert on off-label hydroxychloroquine or chloroquine use for Covid-19 outside of a hospital setting or a clinical trial due to risk of heart rhythm problems. President Trump and his allies have been touting the drug for weeks until recently when new data su rfaced to question its afety and efficacy.

“We authorized their temporary use only in hospitalized patients with Covid-19 when clinical trials are not available, or participation is not feasible, through an Emergency Use Authorization (EUA),” FDA says. “These medicines have a number of side effects, including serious heart rhythm problems that can be life-threatening. We have reviewed case reports in the FDA Adverse Event Reporting System database, the published medical literature, and the American Association of Poison Control Centers National Poison Data System concerning serious heart-related adverse events and death in patients with Covid-19 receiving hydroxychloroquine and chloroquine, either alone or combined with azithromycin or other QT prolonging medicines. These adverse events included QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some cases, death.”

FDA says that patients taking hydroxychloroquine or chloroquine for FDA-approved indications to treat malaria or autoimmune conditions should continue taking their medicine as prescribed. The benefits of these medicines outweigh the risks at the recommended doses for these conditions, it says.

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