Appeals Court Rules in Favor of Labor Department and Home Care Workers

Calling it a “tremendous victory,” Sarah Leberstein, senior staff attorney for the National Employment Law Group said, “Paying workers less than the minimum wage for their work hours, and not paying an overtime premium after 40 hours a week benefits no one.” According to the advocacy group Caring Across Generations, domestic care is one of the U.S.’s lowest paying industry, with an average hourly wage of $9.61.


Fluoroquinolone Antibiotic Neuropathy

Fluoroquinolone antibiotics, such as Cipro and Levaquin, can cause permanent, debilitating side effects. These side effects include fluoroquinolone antibiotic neuropathy, also known as peripheral neuropathy, tendinopathy (the painful inflammation of tendons and tendon rupture. Blurred vision may also occur. In many instances, these side effects persist long after the drugs have been discontinued.


Xarelto Bleeding Risks Equal to Warfarin

A French study shows that the risk of life threatening or uncontrollable bleeding events in patients using Xarelto are no greater than that in patients using Warfarin. However, the study warns that the fact that no reversal agent exists for the effects of Xarelto does not make it safer than Warfarin.


Valeant Buys Sprout Pharmaceuticals, Maker of Just-Approved Female Libido Medication

Valeant’s purchase of Sprout will include $500 million cash up front as well as $500 million when the deal is closed, which is expected to be in early 2016. In addition, Valeant has agreed to give Sprout a portion of future revenues if certain milestones are met, although neither party would discuss specifics. Sprout CEO Cindy Whitehead will join Valeant and lead the division responsible for Addyi.


“Female Viagra” Drug, Flibanserin Approved by FDA on Third Attempt

Unlike its counterpart medications for male erectile dysfunction like Viagra or Cialis, Addyi will not be taken on an “as needed” basis. Citing differences in sexual function between men and women, clinical sex therapist Judy Kuriansky said, “Women’s sexuality is very complicated. It’s not a matter of just taking that pill, by the way, and then all of a sudden the lights go on.” Kuriansky added, “You have to feel good about your body. You have to feel good about yourself. You have to feel the guy really loves you. It’s complex.


Duodenoscope Sterilization a Focus as FDA Warns Three Device Makers

The regulator sent the letters to the Olympus, Fujifilm, and Pentax as part of an effort to fight against a wave of deadly bacterial infections attributed to the insufficient cleaning and sterilization of the devices. Duodenoscopes are reusable flexible tubes that go down the throat in order to treat gastrointestinal tract ailments.


FDA Issued Mammogram Quality Safety Notice

The FDA issued a notice concerning mammogram quality at Boston Diagnostic Imaging in Orlando, Florida. The facility failed its accreditation renewal and a subsequent investigation by the American College of Radiology brought quality issues to light. The facility has also lost its MQSA certification and can no longer legally provide mammograms in the U.S. If you or a loved one had a mammogram done there on or after May 13, 2013, you should consult your doctor as you may possible need a repeat mammogram. NOTE: This does not mean your mammogram results were wrong!


Baby Powder – Ovarian Cancer Link?

“Shower to Shower a day helps keep odors away,” and just may cause ovarian cancer. Johnson’s Baby Powder may also be a culprit. Studies suggest nearly a quarter of women diagnosed used one of these products, leading researchers to think that there may be a baby powder – ovarian cancer link. Estimates provided by the


Three More Birth-Defect Lawsuits add to GSK’s Zofran Tally as MDL Deadline Approaches

The lawsuits accuse GSK of “off-label” marketing, that is, it is prescribed for ailments (pregnancy) that is not mentioned in the drug’s official FDA labeling. Zofran’s 1991 FDA approval was for “treatment of nausea and vomiting related to chemotherapy and surgery.” According to San Francisco attorney Rachel Abrams, speaking at a bar conference in the city regarding the lawsuits, “If they’re marketing and pushing a drug for a certain indication, and don’t have FDA approval for that indication, that’s a problem for GSK in and of itself.”


FDA Warns Drugmaker Duchesnay over Kim Kardashian Instagram Post

Indeed the social media age has brought a new wrinkle in the FDA’s regulatory agenda. Social media marketing schemes are often designed to appear casual and conversational, as if friends are discussing an issue over coffee. While certainly not illegal and for the most part, and a useful form of advertisement, FDA risk statements rarely fit within 144 character-limit social-media parameters.