Drugs

FDA, Pfizer EpiPen Caution

FDA says patients, caregivers, and healthcare professionals should be aware that EpiPen 3.0mg and EpiPen Jr 0.15mg and their authorized generic versions may potentially have delayed injection or be prevented from properly injecting. The agency notice says problems can be due to (1) device failure from spontaneous activation caused by sideways force to remove the blue safety release; (2) device failure from inadvertent or spontaneous activation due to a raised blue safety release; (3) difficulty removing the device from the carrier tube; or (4) user errors.

The notice links to a letter from Pfizer to healthcare professionals that explains each of the potential problems in detail and says it is important for healthcare providers, patients, and caregivers to periodically review the EpiPen user instructions and practice using the EpiPen trainer to ensure proper understanding and use of the EpiPen auto-injector.

“Since EpiPen is administered for severe and potentially life-threatening allergic reactions, anything that prevents or delays the administration of the intended dose of epinephrine could result in a high risk to the patient, including the risk of death,” Pfizer 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