Drugs

Serious Reaction to Some Anti-Seizure Meds: FDA

FDA is warning of a rare but serious drug reaction to two anti-seizure medications — levetiracetam (UCB’s Keppra and Keppra XR, TriPoint Therapeutics’ Elepsia XR, and Aprecia Pharmaceuticals’ Spritam) and clobazam (Lundbeck Pharmaceuticals’ Onfi and Otter Pharmaceuticals’ Sympazan). An agency drug safety communication says the reaction is called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

The notice says risk warnings are being added to the labeling and patient medication guides for the drugs. It says DRESS can include fever, rash, swollen lymph nodes, or injury to organs including the liver, kidneys, lungs, heart, or pancreas.

FDA says its cumulative review found 32 cases of DRESS in children and adults worldwide associated with levetiracetam and 10 cases for clobazam. “Most patients in these cases required hospitalization and received medical treatments,” FDA says, “and two patients treated with levetiracetam died. These numbers include only reports submitted to FDA and found in the medical literature, so there likely are additional cases about which we are unaware. We determined there was reasonable evidence that levetiracetam and clobazam were the causes of DRESS in these cases based on the timing of the onset of these events after receiving the medicines and the order in which they occurred. The majority of cases for which information about discontinuation was available reported that DRESS symptoms improved after the medicines were discontinued.”

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