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FDA assists in Zinbryta MS drug’s removal from U.S. market

A week after drug makers Biogen and AbbVie announced they were pulling the multiple sclerosis (MS) drug Zinbryta from markets worldwide because the medication had been linked to severe liver damage and brain inflammation, the Food and Drug Administration (FDA) announced it planned to assist the drug companies with the management of the withdrawal in the U.S. Zinbryta, known chemically as daclizumab, was approved to treat relapsing MS in the European Union, the United States, Switzerland, Canada, and Australia. Most of the 8,000-plus people treated with Zinbryta live in Germany. The companies announced the withdrawal of Zinbryta after receiving eight ... Read More

Humira user suffers infection that leads to quadruple amputation

A 38-year-old mother of six who was taking the arthritis drug Humira had her arms and legs amputated after developing a cold, which progressed into pneumonia and then sepsis. The family blames Humira for lowering the patient’s immune system, making her susceptible to life-threatening injuries. The Utah woman, Tiffany King, was taking Humira to treat ankylosing spondylitis, a form of arthritis that affects the spine and large joints. Humira, a TNF blocker medicine, lowers the ability of the immune system to fight infections. Users have suffered serious infections including tuberculosis (TB), and infections caused by viruses, fungi, or bacteria that ... Read More

FDA issues warning about devices used to treat aneurysms

Neuromuscular embolization coils containing 304V stainless steel, used to treat brain aneurysms and vascular abnormalities, can cause increased image artifact on follow-up resonance angiography (MRA). This reduced quality of the MRA image can result in inaccurate clinical diagnoses and subsequent inappropriate medical decision, the Food and Drug Administration (FDA) warned in a Safety Communication. Most neurovascular embolism coils on the market are labeled as Magnetic Resonance (MR) Conditional, which lets the user know the conditions of safe use of the device when scanned within an MR environment. The product labeling for these devices does not currently convey the extent of ... Read More

FDA issues warnings to three duodenoscope makers

Three medical device manufacturers were warned by the Food and Drug Administration (FDA) for failing to conduct studies on their specialized endoscopes, called duodenoscopes, to determine if their cleaning and disinfecting guidelines were adequate enough to prevent disease-causing bacteria from spreading from patient to patient. Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestines, called the duodenum. They are used during procedures to diagnose and treat problems in the pancreas and bile ducts. Duodenoscopes are used in about a half million procedures in the U.S. each year. The ... Read More

Salmonella-contaminated Kratom recalled

PDX Aromatics, doing business as Kraken Kratom, Phytoextractum, and Soul Speciosa, is recalling 33 lots of various kratom-containing powdered dietary supplements because some of the products have tested positive for Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. At least one person has been sickened after consuming the herb. Healthy people infected with Salmonella can also experience symptoms like fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare cases, Salmonella infection can result in the organism getting into the bloodstream ... Read More

MO supplement maker faces prison time, fines for felony fraud

A Joplin, Missouri dietary supplement manufacturer is facing up to 20 years in prison after pleading guilty to felony fraud in federal court. Jeff Hicks, owner of JT Naturals, pleaded guilty in U.S. District Court for the Western District of Missouri for misrepresenting ingredients in his dietary supplements his company made and sold to several retail outlets in Florida, New York, California and Oklahoma. Hicks also admitted to lying about conducting tests for potentially dangerous ingredients in the supplements when he actually did not. Hicks was released on a personal recognizance bond. He faces up to 20 years in prison ... Read More

Approval of Xarelto antidote still hangs in the air

A novel drug that reverses the blood thinning abilities of newer anticoagulants called Factor Xa inhibitors could control serious bleeding in patients. If approved by drug regulators, it would be the first antidote on the market that can reverse the effects of Factor Xa inhibition when potentially life-threatening major bleeding events occur. The drug’s effectiveness was suggested by clinical trial results presented at the American College of Cardiology’s 67th Annual Scientific Session. Factor Xa inhibitors work by inhibiting a protein involved in the formation of blood clots. Drugs in this class include Xarelto and Eliquis. They are used to prevent ... Read More

Advances in Burn Injury Care Result in High Survival Rate

Burn injury survivability has increased dramatically over the last 30 years due to major advances in the treatment of severe burn injuries, according to a new study published in the Journal of American College of Surgeons. Surprisingly, no previous studies have analyzed the progress made in burn injury treatments and their effects on patients since major improvements in burn care occurred in the 1980s. “Mortality has decreased three to fivefold since the 1980s, ostensibly from the substantial advances in burn care that occurred between 1980 and 1989,” said lead study author David N. Herndon MD, chief of staff and director ... Read More

Cook fights second IVC filter lawsuit

Arthur Gage waited too long to sue Cook Medical Inc., over claims that the company’s blood clot-catching device caused him serious injuries, according to Law360. Gage sued the company in 2014, but an Indiana federal judge ruled that he should have filed within a year and a day of the product’s delivery in 2011. Gage’s case was the second bellwether in a multidistrict litigation accusing Cook Medical’s IVC filters of causing injuries. IVC filters are tiny cage-like devices that are implanted in the inferior vena cava (IVC), a large vein that carries deoxygenated blood from the lower extremities to the ... Read More

$1 Billion Whistleblower Case Against Hospice Provider Unsealed

A whistleblower lawsuit against one of the nation’s largest hospice care providers was unsealed last week after the federal government declined to intervene. The lawsuit, filed in 2010 against HCR ManorCare by a former regional director of operations under whistleblower provisions of the False Claims Act, alleges the company engaged in a “corporate-wide pattern of conduct that has resulted in the submission of thousands of false claims” and payments of “millions of dollars” to Medicare for patients who were not terminally ill. When a terminally ill Medicare patient enters hospice care, Medicare stops covering traditional medical care designed to improve ... Read More