Drugs

PharmaTech Source of Burkholder Cepacia Outbreak: FDA

FDA says it has identified more than 10 lots of oral liquid docusate sodium manufactured by PharmaTechm, Davie, FL, as the source of a multistate outbreak of Burkholder cepacia. An agency safety update says its investigation also detected B. cepacia in the water system used to manufacture the product. The drugs were distributed and labeled by six firms—Rugby, Major, Bayshore, Metron, Centurion, and Vitus—the notice says.

The agency says it inspected other oral liquid ducosate sodium manufacturers and collected samples of their products and did not find the bacteria associated with the outbreak in any of the other products tested. It also says that current laboratory results do not indicate the active pharmaceutical ingredient used to manufacture oral liquid docusate is a source of the outbreak.

“Healthcare professionals may resume normal use of oral liquid ducosate sodium not manufactured by PharmaTech,” the notice says. “FDA reminds manufacturers of the importance of robust manufacturing and testing of liquid products such as ducosate sodium to ensure low levels of microorganisms and the absence of those that may cause infection.”

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