FDA Warns Against NSAIDs in Pregnancy After 20 Weeks
The FDA issued a drug safety communication about nonsteroidal anti-inflammatory drug (NSAID) use during pregnancy, mandating that product labels include warnings about risk of a rare but serious kidney complication in infants.
Use of over-the-counter or prescription pain medications -- including aspirin, ibuprofen, naproxen, diclofenac, and celecoxib -- after 20 weeks of pregnancy could potentially...
A diabetes drug has been recalled because it contains high levels of cancer-causing agent
(CNN) - A widely-used diabetes drug has been recalled after manufacturers found it contained unacceptably high levels of a cancer-causing contaminant.
Indian pharmaceutical company Marksans Pharma Limited is recalling metformin hydrochloride extended-release tablets because their levels of NDMA, a "probable human carcinogen," were higher than the acceptable daily intake limit of 96 nanograms per day,...
FDA moves to pull preterm birth drug from market
Removal of a medicine cleared after an accelerated approval would be a highly unusual step, but it is the way the process is supposed to work. The FDA grants quick clearance to medicines that fill an unmet need, while requiring additional data to further prove safety and effectiveness.
In this case, the FDA approved Makena...
Popular anti-anxiety medications may be highly addictive, FDA says. But is the warning too late?
The U.S. Food and Drug Administration said last month it will now require makers of benzodiazepines to outline the risks of abuse, addiction, physical dependence and withdrawal on the drugs' labels.
Benzodiazepines, or "benzos," which include brand name drugs like Xanax, Ativan, Klonopin, Librium and Valium, are used for the treatment of anxiety, insomnia, seizures,...
Honda confirms 17th U.S. death in Takata air bag rupture
WASHINGTON (Reuters) - Honda Motor Co said on Saturday it has confirmed a 17th U.S. death tied to a faulty Takata air bag inflator.
The Japanese automaker said that after a joint inspection with the U.S. National Highway Traffic Safety Administration (NHTSA), it confirmed a faulty air bag inflator was to blame for the Aug....
Company to pay $60M for deceptive marketing with pelvic mesh
JACKSON, Miss. (AP) — A company that failed to adequately inform women of dangerous side effects related to permanent pelvic mesh devices will be required to pay $60 million, according to a settlement announced this week by state attorney generals across the U.S.
The money from C.R. Bard, Inc. and its parent company Becton, Dickinson...
FDA requires stronger warning label for Xanax, Valium and other similar benzodiazepine drugs
The U.S. Food and Drug Administration is requiring a stronger warning label on a group of drugs commonly used by many Americans for anxiety, the agency announced Wednesday.
All benzodiazepine products, which include well-known drugs such as Xanax and Valium, must have warning labels that spell out the risks of abuse, misuse, addiction, physical dependence...
FDA warns popular dental filling could cause health problems for some patients
The US Food and Drug Administration warned Thursday that silver dental fillings, known as dental amalgam, may cause health problems for some high-risk groups.
The updated FDA guidance said the filling material could lead to health issues for those with a hypersensitivity to mercury.
Learn more here
Discipline against bad doctors plummets amid COVID-19 – and more medical errors may slip through cracks
As hospitals filled with COVID-19 patients and the coronavirus infected physicians and nurses, state medical boards took a hands-off approach to doctor discipline: Emergency actions against doctors' licenses dropped 59% from April through June of this year compared with the same period last year.
Emergency license suspensions and restrictions dropped 85% in April alone,...
Medical Errors Are No. 3 Cause Of U.S Deaths, Researchers Say
A study by researchers at Johns Hopkins Medicine says medical errors should rank as the third leading cause of death in the United States — and highlights how shortcomings in tracking vital statistics may hinder research and keep the problem out of the public eye.
The authors, led by Johns Hopkins surgeon Dr. Martin Makary,...