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Korea adds severe skin reaction warning to Xarelto

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Korea’s Ministry of Food and Drug Safety (MFDS) is requiring an update to the safety label of the blood thinner Xarelto to include new warnings regarding the risk of the serious and sometimes fatal skin reactions known as Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). The warning comes after the European Commission issued a public safety alert regarding serious skin conditions with Xarelto. Most side effects were reported within the first week of treatment. The ministry collected opinions and reviewed them last month and determined that the warnings should also come with a recommendation for doctors to discontinue ... Read More

Chemical Release Puts Baltimore Communities Under Temporary Lockdown

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A chemical spill that sent a plume of acid gas into the air prompted officials to put three Baltimore area communities under an emergency shelter-in-place order Monday morning. The leak occurred at the Solvay plant when a tank truck delivering chlorosulfonic acid, a raw material used for producing soaps and detergents, leaked from a valve as it was being transferred by hose to a trailer. The chemical, which produces a white cloud when exposed to air, is extremely corrosive to the eyes, skin, and respiratory tract, the U.S. Centers for Disease Control and Prevention (CDC) says. Symptoms associated with inhaling ... Read More

Supplements don’t meet ‘medical food’ requirement

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ND Labs Inc., promoted its dietary supplements as medical foods for people with a host of conditions including pressure ulcers, trauma, chronic constipation, and muscle weakness, but the Food and Drug Administration (FDA) said it wasn’t aware of any distinctive nutritional needs for people with those conditions. Furthermore, the products didn’t even fit the definition of a medical food under the Orphan Drug Act. As a result, the dietary supplement maker was slapped with a warning letter. “Medical foods are not those simply recommended by a physician as part of an overall diet to manage the symptoms, or reduce the ... Read More

County Fair Draft Horse Chairman Thrown from Wagon, Killed

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Just weeks after the Ohio State Fair incident that killed one and injured several more, another fair has turned deadly. The Meadville Tribune reports that Wednesday afternoon, 64-year-old Charles E. Burns, the chairman of the draft horse competition department, was killed when he was thrown from his horse-drawn wagon as he rode around the horse ring of the Crawford County Fair in Pennsylvania. According to witnesses, Burns was driving a wagon pulled by a team of draft horses when it made a sharp turn, throwing Burns forward beneath the hooves of the giants. The horses became spooked and began bucking. Emergency ... Read More

Is Equifax Shopping for a Coffin After Data Breach?

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Equifax’s failure to fend off hackers, who accessed the personal and financial information of 143 million Americans, has doomed the credit-reporting company, a technology attorney predicts. New York City-based technology law expert Mark Grossman told CNBC that he doesn’t see how Equifax could recover from the massive data breach. “We’ve seen a $6 billion loss in market cap, estimated losses from these breaches in excess of $20 billion,” he said in an interview on CNBC’s program “Closing Bell.” “This is ugly. The facts are still unfolding. It’s going to get worse. … We’re pointing to a bankruptcy. We’re pointing to ... Read More

Whistleblower Helps U.S. Recover $4M From NY Hospital Operator

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The corporate owner-operator of two Queens, New York, hospitals has agreed to pay $4 million to settle a whistleblower lawsuit alleging it unlawfully billed Medicare for services forged from unlawful financial relationships with referring doctors. According to the whistleblower lawsuit, MediSys Health Network, Inc., which owns and operates Flushing Hospital Medical Center and Jamaica Hospital Medical Center, violated the False Claims Act by failing to comply with the requirements of the Stark Law, which restricts the financial relationships that hospitals may have with the physicians who refer patients to them. “When hospital operators provide financial incentives to doctors for patient referrals, ... Read More

Study compares Zytiga and Taxotere for high-risk prostate cancer treatment

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A recent study compared Zytiga (abiraterone acetate) plus prednisolone (AAP) versus Taxotere (docetaxel). The study analysed data gathered in STAMPEDE, a Phase 2/3 trial, which has prospectively studied more than 9,000 patients and includes six different approaches to treating high-risk or metastatic hormone sensitive prostate cancer. Two of the treatments included in STAMPEDE were AAP and Taxotere added to the standard hormone deprivation therapy, with 377 patients randomly assigned into the AAP treatment group and 189 into the Taxotere group. Both drugs had previously shown promise in improving survival in patients with high-risk prostate cancer when compared to the standard treatment ... Read More

Self-Driving Car Ready For Mass Production, GM and Cruise Announce

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A unit of General Motors developing self-driving auto technology announced that it is ready to begin production of fully automated, driverless cars on a mass scale once the software is fully developed and the regulatory environment is ready. “Today, we’re announcing the first production design of a self-driving car that can be built at massive scale,” Kyle Vogt, CEO and founder of Cruise Automation, a self-driving car developer that GM acquired as a startup last year, told Tech Crunch. “And more importantly, these vehicles can operate without a driver.” All the mechanical components of the self-driving cars are in place. ... Read More

Homeopathic drugs found to contain rat poison

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HomeoCare Laboratories Inc., a homeopathic company that makes drugs aimed to boost the immune system and treat symptoms of the cold and flu, was slapped with a Food and Drug Administration (FDA) warning letter for manufacturing drugs that contain the highly toxic rodent-killer strychnine. “You manufacture various homeopathic drugs from ingredients that pose potentially toxic effects,” the warning letter stated. “For example, some of your drugs include the ingredient nux vomica, which contains strychnine.” The agency called into question HomeoCare Laboratory’s procedures to ensure the quality and strength of its drugs conform to set standards. “Especially for drugs that contain ingredients ... Read More

Florida nursing home barred from accepting patients

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The Agency for Health Care Administration (ACHA), under the direction of Florida Gov. Rick Scott, placed an emergency moratorium on Rehabilitation Center at Hollywood Hills, the nursing home where eight patients died after Hurricane Irma knocked out the power. All residents who were at the facility were subsequently evacuated to a nearby hospital. The moratorium immediately prevents the nursing home from admitting any other patients until the order is lifted. The order “is necessary to protect the lives and the safety of frail elders,” ACHA’s press release stated. “Gov. Scott made it clear today he is demanding answers … and ... Read More