Drugs

Suspend Vitamin B6 Sales: Emery Pharma Petition

Emery Pharma is asking FDA to issue a regulation, revise industry guidance, and request a recall and suspend sales of vitamin B6 (pyridoxine) from the U.S. market. A 9/20 petition says mega doses (50-500 mg) of vitamin B6 are widely available over-the-counter and online. When taken in excess, the petition says, vitamin B6 can cause symptoms of peripheral neuropathy and neurotoxicity.

Emery says FDA should implement safe guidelines for using “this widely abused vitamin,” including:

asking manufacturers of vitamin B6 or B-complexes to include labeling about the vitamin’s potential toxicity, including a warning to consumers to discontinue B6 supplementation if they experience signs or symptoms of toxicity; and
reclassify doses greater than 10 mg as behind-the-counter and available by prescription only, under the supervision of a physician with proper monitoring.

Emery says there is an existing precedent for its recommendation since vitamin D supplementation includes several strengths (400 IU to 10,000 IU) available over-the-counter but there is a requirement that patients prescribed 50,000 IU must have a prescription and lab monitoring under the supervision of a physician. “This principle should be applied in the case of vitamin B6,” the petition 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