May 22, 2017
FDA Adds Amputation Risk To Invokana’s Black Box Warning
The Food and Drug Administration (FDA) added a black box warning to Invokana, a new-age drug used to treat diabetes. The black box warning, which is the agency’s highest-level alert, was released in a safety communication on May 16.
The warning comes after the CANVAS and CANVAS-R studies confirmed a significant increase in risk of leg and foot amputations for patients taking Invokana. Results showed that Invokana users were twice as likely to require an amputation compared to patients who took a placebo.
Missouri Jury Awards $110 Million To A Woman Who Developed Ovarian Cancer
A St. Louis jury ordered Johnson & Johnson (J&J) to pay $110 million to a Virginia woman who developed ovarian cancer after using talcum powder for four decades. Lois Slemp, diagnosed in 2012, has been undergoing chemotherapy to treat talc-based cancer that spread to her liver. Slemp’s lawsuit is one of 2,400 complaints brought against J&J.
On May 4, Slemp was awarded $5.4 million in compensatory damages and $105 million in punitive damages to be paid by J&J, who was found to be 99 percent at fault for failing to warn consumers about the risks. The talcum distributor, Imerys Talc, will pay $50,000 in punitive damages.
California Study Shows Testosterone May Increase Impulsiveness
A study from the California Institute of Technology, published April 28, found testosterone can increase impulsiveness in men. The study, “single dose testosterone administration impairs cognitive reflection in men,” indicates that testosterone may limit the brain’s ability to check itself during reflection processes, which could impair decision making and lead to more impulsive choices.
Researchers provided doses of testosterone to 243 college-age males and tested their subsequent reflections. The study concluded testosterone “decreases the probability of engaging in slow and effortful cognitive processes, but keeps the capacity to perform them intact.”
Ohio Government Pushes For Performance-Based Funding In Nursing Homes
The Ohio Senate is currently debating changes to nursing home funding, which would affect the state’s nearly 1,000 residential care facilities. Data recently released by the Scripps Gerontology Center review shows that, on average, facilities in Ohio fall below quality ratings.
Spearheaded by Republican Gov. John Kasich, the budget proposal urges the state to adopt a performance-based funding system that replaces the guaranteed payment mandates. The proposal, aligned with recent data from the Ohio Department of Medicaid that indicates smaller and not-for-profit facilities perform better, aims to reward higher-quality homes.
Survey Shows Mesh Complications Are Unrecognized As U.K. Agency Aims To Draw Attention To Women’s Health
A survey focusing on awareness of 123 vaginal mesh patients indicates some doctors don’t acknowledge the device’s potential for complications, which makes it more difficult to diagnose and treat mesh injuries. More than half of the respondents, members of the popular Sling The Mesh forum, chose not to report their complications to the U.K. government for related reasons.
Responses showed that when women did file reports, 20 percent of doctors were not familiar with mesh as a treatment for POP and SUI, and 45 percent of doctors did not believe their pain could be related to failed mesh. The survey is released as the U.K.’s All-Party Parliamentary Group works to make strides for women to be treated with “dignity and respect” when seeking medical help.