News: The antipsychotic Zyprexa (olanzapine) can cause a rare but serious skin reaction that can progress to other parts of the body, according to a drug safety communication from the FDA. The agency is adding a new warning to the labeling for all olanzapine-containing products that describes this severe condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). A search of the FDA Adverse Event Reporting System database identified 23 cases of DRESS reported with Zyprexa worldwide since 1996, when olanzapine was first approved. Posted May 10, 2016. Via FDA.
People on the blood clot-preventing drug warfarin showed a higher dementia risk if their blood
levels of the medication were frequently too high or too low, according to researchers at the Intermountain Medical Center in Utah. The findings are based on records from over 10,000 patients who were on warfarin for atrial fibrillation or to prevent blood clots from other causes. Over 6 to 8 years, almost 6% of the atrial fib patients developed dementia, including Alzheimer’s disease — versus less than 2% of other warfarin patients. Posted May 5, 2016. Via HealthDay News.
News: Some people addicted to oxycodone and other opioids are turning to over-the-counter diarrhea medicationsto manage their withdrawal symptoms or get high. Researchers at SUNY Upstate Medical University describe two case studies where people who were addicted to opioids tried to ease their withdrawal symptoms by taking many times the recommended dose of loperamide (sold under the brand name Imodium), a drug used to treat diarrhea. Both patients died. “Because of its low cost, ease of accessibility and legal status, it’s a drug that is very, very ripe for abuse,” said lead author William Eggleston, PharmD, a fellow in clinical toxicology at the Upstate New York Poison Center. Posted May 3, 2016. Via NPR.
Taking cholesterol-lowering statins right before heart surgery has no benefitand may even cause harm, a new University of Oxford study suggests. Crestor (rosuvastatin) did not prevent either the abnormal heart rhythm known as atrial fibrillation or heart damage, and it was linked to a slightly increased risk of kidney damage, researchers said. The percentages of those who developed atrial fibrillation were essentially the same in patients given Crestor (21.1%) and those given a placebo (20.5%), the investigators found. Posted May 4, 2016. Via HealthDay News.
If the 21st Century Cures Act “is not carefully crafted, it could pose a significant risk”for the agency and patients too because it could cause drugs and devices to be approved too quickly, FDA Commissioner Robert Califf said. The goal of the legislation, which passed last year, is to speed the approval of innovative drugs and medical devices. Califf told attendees at the Food and Drug Law Institute Annual Conference that the FDA’s “fundamental challenge” is how to provide guidance and oversight that promotes innovation, while also ensuring product safety. Posted May 6, 2016. Via Bloomberg BNA.
