“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.


Malpractice Litigation Made Easier Through Video Replays!

The newest development in surgical technology is not an instrument or a special technique; it’s basically a “black box” device that records the actions taken by the surgical team during the procedure. Legislators in Wisconsin and New York have introduced bills that, if passed, give patients the rights to the video recordings of their surgeries.


FDA Approves Nestle’s Maggi Noodles, Banned in India

Foodmaker Nestle scored a major victory late Monday night when the U.S. Food and Drug Administration (FDA) granted marketing approval for the company’s Maggi noodles within the U.S. The U.S. joins six other countries in allowing the sale of the two-minute instant snack noodles, which had been tested by the regulator for unsafe levels of


Big Pharma Wins First Cymbalta Withdrawal Suit

There are approximately 250 pending lawsuits against drug manufacturer Eli Lilly over its wonder-child, Cymbalta. Plaintiffs claim that the withdrawal symptoms experienced occur much more frequently than the Big Pharma giant warns. The first case went to trial this month and Big Pharma wins the first Cymbalta withdrawal suit. The drug, which brings Lilly about


Medtronic Issues Recall for Newly-Approved Heart Device

Leading medical device manufacturer Medtronic has issued its second recall in as many weeks involving recently developed technology. Coming off of the European recall of its MiniMed 640 insulin pump last week, which is scheduled for a Pre-Market Approval (PMA) review in the U.S. later this year, the company has recalled nearly 7,000 EnVeo R