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Xarelto makers want to strike doctor’s testimony


The makers of the blood thinner Xarelto asked the Louisiana federal judge overseeing the third bellwether trial currently underway to strike testimony from a physician about a proposed change to the drug’s safety label that was redlined by the Food and Drug Administration (FDA), according to Law360. The case involves that of Dora Mingo, who blames the blood thinner for causing her gastrointestinal bleed. She was taking the medication to treat deep vein thrombosis she developed after undergoing hip replacement surgery. She claims that Johnson & Johnson’s Janssen Pharmaceuticals and Bayer, makers of Xarelto, should have informed doctors on its safety ... Read More

Beware of Chinese Made Copper Pipe, watchdog Group Warns


Beware of Chinese-made copper pipes, pipe fittings, and other plumbing supplies not made in the U.S., consumer watchdog group Plumbing Pipe Advocate advises, adding that homeowners could find themselves with little legal recourse if they experience a major plumbing failure caused by defective materials. According to the group, “As we have seen with other Chinese made building products such as toxic Chinese drywall, if the homebuilder goes broke because they used defective construction products the homeowner’s only recourse may be attempting [to] file a lawsuit against a Chinese company. As we saw with toxic Chinese drywall the Chinese do not stand behind the products ... Read More

Sterility concerns with Vital Rx products

antibiotics - vials, test tubes

The Food and Drug Administration (FDA) is warning health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by Vital Rx Inc., doing business as Atlantic Pharmacy and Compounding, because the sterility of the products cannot be determined. This poses a health risk to people who use these products. Healthcare professionals and patients should immediately check their inventories and quarantine any drug products by Vital Rx Inc., or Atlantic Pharmacy and Compounding. The FDA inspected Atlantic Pharmacy’s Pompano Beach, Florida, facility and observed insanitary conditions including poor sterile practices that bring ... Read More

Takata Airbags Trigger Recall of Nearly 80,000 older Mazda Vehicles

Takata airbag - image source alexauto321, wikicommons

Defective Takata airbags have prompted another safety recall, this time affecting nearly 80,000 older Mazda cars and SUVs. The National Highway Traffic Safety Administration (NHTSA) said the recall covers certain 2007 through 2009 and 2012 Mazda CX-7, CX-9, and Mazda 6 vehicles in the U.S. According to the Associated Press, Takata airbags in some of the vehicles are being recalled for the second time. A previous recall in January replaced some Takata airbag inflators with the same parts that were thought to be somewhat safer than the originals. The replacements, however, are still susceptible to degradation because they are powered ... Read More

Deaths with intragastric balloon obesity treatment

bathroom scale, diet, weight

Five unanticipated deaths since 2016 have occurred in patients who were implanted with liquid-filled intragastric balloon systems to treat obesity, the Food and Drug Administration (FDA) announced in a Safety Communication. Four of the deaths occurred with the Orbera Intragastric Balloon System manufactured by Apollo Endo Surgery. One report involved the ReShape Integrated Dual Balloon System made by ReShape Medical Inc. All five patient deaths occurred within a month or less of balloon placement. In three reports, death occurred as soon as one to three days after balloon placement. “At this time, we do not know the root cause or ... Read More

Amputation, Concussion Among Minnesota School Explosion Injuries

explosion, school, Minnesota, Minnehaha - image by WCCO CNN

Doctors performed a leg amputation and several concussion screenings on the survivors of a Minneapolis, Minnesota school explosion Aug. 2. A soccer coach who was critically injured in the Minnehaha school explosion is recovering from a leg amputation, while several others are being monitored for concussions and other head injuries similar to combat vets returning home from war. The wife of Bryan Duffey, an assistant boys soccer coach at Minnehaha Academy, said her husband continues to make progress after being critically wounded in the natural gas explosion at the school. He has undergone three surgeries and will have a major skin graft surgery in the ... Read More

Utah Woman Sues Costco For E. Coli Injuries

chicken salad sandwich - Wikimedia Commons

A Utah woman who contracted a severe and debilitating form of E. coli illness after eating chicken salad linked to a multistate outbreak is suing Costco, alleging it permanently ruined her health, quality of life, and acting aspirations. Chloe Rodgerson was just 18 years old when she became extremely sick after eating Costco chicken salad in October 2015. She started to vomit blood and her health deteriorated to the point where she was left fighting for her life in intensive care. No connection was made between her illness and the chicken salad immediately, so doctors were testing Ms. Rodgerson for ... Read More

CVS boots Jardiance for more risky Invokana


CVS Caremark is booting the type 2 diabetes drug Jardiance as a preferred option in favor of Invokana, despite Invokana showing more adverse events than its competitor. Eli Lilly and Boehringer Ingelheim’s Jardiance, and Johnson & Johnson’s Janssen Pharmaceuticals’ Invokana are in the same drug class known as SGLT2 inhibitors. Both drugs have posted a 14 percent composite reduction in cardiovascular risks in studies, a highly desirable marker for a diabetes drug. But the move by CVS has some analysts scratching their heads. While both drugs provide cardiovascular benefit, many drugs in the class have been rife with adverse events ... Read More

FDA considers first oral testosterone treatment

Low T

Two drug companies – both plagued by fits and starts– are racing to see which will be the first to gain Food and Drug Administration (FDA) approval for the first testosterone pill that can be taken by mouth. This week Lipocine announced it had resubmitted a New Drug Application (NDA) to the FDA for LPCN 1021, it’s oral testosterone replacement therapy designed to boost testosterone in men with low levels of the male hormone, a condition called hypogonadism. Lipocine had previously submitted an NDA to the FDA in June 2016 but was rejected. The agency cited problems with the dosing ... Read More

Proposed Sleep Apnea Rule Withdrawn

sleepy truck driver sign

A proposed rule addressing the deadly risk of obstructive sleep apnea for commercial drivers and other transportation workers has been struck down by two federal agencies. According to a Federal Register posting, the Federal Motor Carrier Safety Administration (FMCSA) and the Federal Railroad Administration (FRA) are abandoning regulatory efforts to reduce the number of drowsy-driver related crashes by requiring testing and treatment of sleep apnea. The proposed rule becomes the latest safety regulation to be thrown on the chopping block by the Trump Administration, alarming safety experts who have demonstrated through years of research how serious safety deficiencies in current ... Read More