Invokana
Regulations
FDA’s Boxed Warning Prompts Physicians To Take Diabetes Patients Off Invokana
Results from the government-mandated CANVAS study show the diabetes drug Invokana can double the risk of lower limb amputations. The findings prompted the Food and Drug Administration (FDA) to add a black box warning to Invokana’s labeling on May 16.
The increased risk of amputation has affected the intent to prescribe and treat diabetes patients with Invokana. According to MedPage Today, physicians and hospitals have started to discontinue use of the popular diabetes medication.
Nursing Homes
Advocacy
Government Investigators Discover Severe Nursing Home Abuse Isn’t Being Reported
After finding a disturbing number of severe nursing home abuse cases are not being reported, the Office of Inspector General at the Department of Health and Human Services issued an urgent alert. Federal law requires serious cases of abuse to be turned over to local police, but investigations show that authorities are not being informed—even when the abuse is so severe it could warrant an emergency room visit.
“More than one-quarter of serious cases of nursing home abuse are not reported to the police,” NPR reports. While government investigators conduct an ongoing review of nursing home abuse, they are calling for changes to begin immediately.
Xarelto
Studies
Xarelto Compass Trial Downplays Risk of Bleeding
A recent study, known as the COMPASS trial, showed the blood thinner Xarelto can reduce the risk of heart attack and stroke when combined with aspirin. The positive cardiovascular results, hailed as a victory for manufacturers, were showcased at the European Society of Cardiology 2017 Congress.
A MedScape editorial reported small differences in risk reduction, as major bleeding with Xarelto doubled in patients older than 75 years. “Although major bleeding was higher with rivaroxaban/aspirin, fatal bleeding did not differ,” according to MedScape.
Roundup
Drugs Abroad
Regulators Question EU Report Using Monsanto's Study To Confirm Herbicide Safety
New information has led to questions about the validity of the European Food Safety Authority's (EFSA) choice to reject the World Health Organization's carcinogenic classification of glyphosate, the main ingredient in the herbicide Roundup.
The Guardian revealed that dozens of pages from the 2015 assessment report were directly copied from a study conducted by the herbicide's manufacturer Monsanto. The revelation comes as the European Union debates whether it should extend the approval licensing of Roundup, the world's most popular herbicide, though it has been linked to non-Hodgkin's lymphoma and other health issues.
Talcum Powder
Legal Developments
Jury Awards $417M in California Talcum Powder Lawsuit
A Los Angeles jury awarded a record $417 million in a talcum powder lawsuit. California resident and plaintiff, Ana Echeverria, alleged that Johnson & Johnson failed to warn their consumers about the risks involving prolonged talcum powder use and ovarian cancer.
Further studies have strengthened the connection between talcum powder and ovarian cancer, but Johnson & Johnson continues to defend their product’s use and safety. More than 1,000 women have filed lawsuits against Johnson & Johnson, imploring the company to inform consumers of the risks involving long-term Baby Powder use. Read the full MedTruth article here.