On February 9, 2009, a North Carolina resident was implanted with the Obtryx Transobturator Mid-Urethral sling. This patient filed suit against the maker of her vaginal mesh, Boston Scientific (“Boston”), asserting claims of breach of express and implied warranties, negligence, punitive damages, and strict liability (design defect, failure to warn, and […]
Category: Articles
Diabetes is the seventh leading cause of death in the U.S. Invokana (canagliflozin) is a diabetes medicine that helps control blood sugar levels. Canagliflozin works by helping the kidneys clean glucose from your bloodstream. The most serious potential side effects, problems and risks caused due to the use of Invokana […]
In a strange twist of fate, a class of drugs that help reduce the painful burning feeling in your chest caused by indigestion (if you suffer from a disease like gastroesophageal reflux disease) may also increase your risk of a heart attack. A new study conducted by a team of […]
It’s a scary day when even the federal government can’t keep a laboratory sterile for drug-making. Following the New England Compounding Center (NECC) fungal outbreak in 2012, the Food and Drug Administration (FDA) has shut down the government’s own compounding pharmacy run by the National Institutes of Health (NIH) over […]
The FDA recently announced that it is investigating allegations of improprieties in conjunction with clinical trials that were conducted by Bayer and Conceptus with regard to the Essure device, which is utilized in sterilization procedures. Bayer Corporation, a German pharmaceutical giant, purchased Conceptus, the original designer of the Essure device, […]
A reported 100,000 Americans, including a 54-year-old Illinois man and 36-year-old North Carolina woman, have reported severe side effects from Levaquin, an antibiotic that packs enough pill power to kill anthrax. Levaquin, a drug classified in the fluoroquinolone family, is now undergoing another Food and Drug Administration evaluation because of the controversy. Twelve […]
New Medications Meet Unmet Patient Needs The Food and Drug Administration’s approval of 41 novel new drugs in 2014 made it a banner year for the pharmaceutical industry. The class of 2014 included biologicals, drugs that treat cancer and infectious diseases (bacterial, fungal, parasitic and viral) and therapeutic drugs. The […]
At the Food and Drug Administration’s Center for Devices and Radiological Health, the new year started off with an approval of the first therapeutic weight loss option for obese patients since 2007. The device – the Maestro Rechargeable System – was given a thumbs-up following a scientific study of a […]
Safeguarding, streamlining, strengthening the clinical trial process is one of three of the Food and Drug Administration’s primary goals for 2015. So states an 11-page document titled 2014 – 2015 Strategic Priorities. The other two goals focus on 1) striking a better balance between data collection requirements and the time […]
Since the passage of the “Dietary Supplement and Health Education Act,” the supplement industry has effectively been a wild west of snake oil salesmen foisting their sometimes fraudulent and dangerous miracle cures on the American public. We’ve been writing about this terrible federal law for years – a law that […]
