FDA warns against using Doribax in patients with ventilator-associated bacterial pneumonia
Doribax (doripenem), an antibacterial drug that is sometimes used off-label to treat patients who develop pneumonia while on ventilators, increases the risk of death and has lower clinical cure rates compared to the injectable drugs Primaxin (imipenem and cilastatin), the
FDA revises guidelines for off-label drug use
The Food and Drug Administration (FDA) is amending its policies for drug makers and medical device manufacturers to help better define how scientific studies for unapproved uses can be shared with physicians without legal implications.
GE Healthcare recalls newborn resuscitator systems
GE Healthcare is ordering a recall of some of its resuscitation systems designed to deliver oxygen to newborns. The recall is due to a manufacturing error that may interfere with oxygen delivery and may lead to low blood oxygen (hypoxia)
Short-term use, lower doses of Actos linked to increased bladder cancer risk
People who have been treated with the type 2 diabetes medication Actos (pioglitazone) for more than six months may be at greater risk of developing bladder cancer, even if they were on a low dose, according to a new study
Hundreds of Australian women file transvaginal mesh lawsuit against Johnson and Johnson
Nearly 400 Australian women have filed transvaginal mesh injury lawsuits against Johnson & Johnson in what may be the biggest product liability class action lawsuit in Australian history. The women claim the company’s surgical mesh product used to treat pelvic
Medical groups want children to have their cholesterol levels checked
Children ages 9-11 should have their cholesterol levels checked by their pediatricians, recommends the National Heart, Lung and Blood Institute.
Study: Acute pancreatitis greatly increases risk of pancreatic cancer
People diagnosed with acute pancreatitis are more likely to develop pancreatic cancer, according to a new study published in the journal Clinical Gastroenterology and Hepatology.
FDA, EMA still investigating pancreatic problems with diabetes drugs Byetta, Januvia
U.S. and European drug regulators have yet to reach a final conclusion about whether a widely prescribed class of type 2 diabetes drugs increases the risk of pancreatic problems. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency
Controversy surrounds upcoming FDA decision on long-acting testosterone drug
The Food and Drug Administration (FDA) is expected to decide this week the fate of a long-acting testosterone product made by Endo Health Solutions, Inc. Aveed, indicated to boost testosterone in men with low levels of the hormone, has been