FDA blasts another U.S. drugmaker for faulty quality controls on now-recalled thyroid meds
The COVID-19 pandemic has put a damper on the FDA's on-site inspections in 2020, but that doesn't mean the agency isn't making the rounds and putting drugmakers on notice. A second U.S. company making prescription thyroid meds is on the receiving end of FDA's ire this year for potency concerns.
FDA investigators cited Phoenix-based RLC...
Lost Chance as Substantial Factor In Causing Injury: Part 1
In medical malpractice cases competent poof of a diminished chance for a cure or better outcome or increased injury and pain and suffering may be a substantial factor or proximate cause of injury. Part 1 of this article will deal with such evidence as presented in failure to diagnose and treat cancer cases while...
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...
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.
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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,...
