Drugs

FDA Acting Against Unapproved Thyroid Meds

FDA says it plans to take action against unapproved animal-derived thyroid medications. An online statement outlines the agency’s concerns with the unapproved medications, saying tablets made from the same manufacturing batches may not always provide the same thyroid hormone levels, and thyroid medications derived from animal thyroid glands have an increased risk of certain impurities due to the source or the way it is manufactured.

“The agency has received complaints from patients and reports of adverse events related to the safety and potency of these unapproved medications,” FDA says.

The statement includes a link to letters the agency sent on 8/6 to manufacturers, importers, and distributors of marketed unapproved animal-derived thyroid medications, notifying them of the agency’s intent to act against the unapproved meds. The letters say FDA expects it will take up to 12 months for doctors to successfully transition patients to an FDA-approved thyroid hormone replacement drug.

“Manufacturers, importers, and distributors of unapproved animal-derived thyroid medications may be subject to compliance action if they commercially distribute their unapproved products,” the notice says. It also notes that unapproved animal-derived thyroid medications may not be compounded because they are regulated as biologics.

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