Drugs

Safety Alert on Potential Label Problems with EpiPen

FDA has issued a safety alert about labels attached to some Pfizer/Mylan EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, which may block access to the auto-injector and prevent the ability to easily access the product. The alert also applies to authorized generic versions of the product. An 11/1 letter from Pfizer and Mylan says the label sticker on the auto-injector unit may have been improperly applied, causing resistance when removing it from the carrier tube. The carrier tube is the immediate package in which the auto-injector is contained. “In some cases, the patient or caregiver may not be able to quickly remove the epinephrine auto-injector from the carrier tube,” the alert says.

Patients and caregivers are advised to inspect their epinephrine auto-injectors prior to needing it to ensure they can quickly access the product. The letter also describes how to inspect potentially affected products and explains that patients should contact Mylan Customer Relations at 800-796-9526 if an auto-injector does not slide out easily from the carrier tube or the label is not fully adhered to the auto-injector.

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

Read more

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