Current Events

(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, according to a recall published this week by the US Food and Drug Administration (FDA).

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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, social phobia and panic disorder.

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 in 2011 based on a study that showed it could help prevent preterm birth in women who had previously had an unexplained preterm birth, defined as delivery before 37 weeks. The agency then required AMAG to show the medicine could actually improve the health of babies, the ultimate goal of reducing preterm birth.

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.
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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.
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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.

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 and withdrawal. The FDA has called for a “Boxed Warning,” which is the agency’s most prominent safety warning.
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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, according to the federal Health Resources and Services Administration, which administers the National Practitioner Data Bank and provided the analysis to USA TODAY. HRSA is an agency of the U.S. Department of Health and Human Services intended to improve health care for the vulnerable and support training of medical professionals.
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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, call for changes in death certificates to better tabulate fatal lapses in care. In an open letter, they urge the Centers for Disease Control and Prevention to immediately add medical errors to its annual list reporting the top causes of death.

Bayer will pay $1.6 billion to settle lawsuits from thousands of American women who said they developed debilitating long-term health problems from the pharmaceutical giant’s product, the Essure birth control implant.

A company statement Aug. 20 said the offer would end 90% of the nearly 39,000 cases now in court or not yet filed, and Bayer is negotiating to settle the other claims. The settlement does not require Bayer to acknowledge liability or wrongdoing.

Two life-saving tuberculosis drugs were found to contain elevated levels of chemicals that may cause cancer, according to the Food and Drug Administration, but the treatments will be allowed to remain on the market out of worry that supplies could run short.

The drugs rifampin and rifapentine contain nitrosamine impurities, the FDA said in a statement Wednesday. A similar chemical contamination led to recalls in the past two years for millions of blood-pressure pills, as well as brand and generic forms of the heartburn medicine Zantac and a popular diabetes therapy. Some nitrosamine compounds are considered possible or probable human carcinogens.