Drugs

FDA Probes Burn Reports with Migraine Patch Users

FDA says it is investigating reports of serious burns and potential permanent scarring in users of NuPathe’s battery-powered Zecuity (sumatriptan iontophoretic transdermal system) patch, indicated for treating acute migraines with or without aura in adults. “We are investigating the cause and extent of these serious side effects and will update the public with new information when our review is complete,” an agency drug safety notice says.

In 2013, the agency approved the single-use patch that delivers sumatriptan through the skin, but marketing of the product did not begin until 9/2015. Since then, there have been a large number of patients who have reported experiencing burns or scars on the skin where the patch was worn, according to FDA. “The reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin,” it says. “As a result, we are investigating these serious adverse events to determine whether future regulatory action is needed.”

FDA advises that patients who experience moderate to severe pain at the Zecuity patch site should immediately remove it to avoid possible burns or scarring. They should also not bathe, shower, or swim while wearing the patch.

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