Alerts and implant recalls

Under pressure to strengthen oversight on the superbug scope that killed two people and possibly infected hundreds of others at UCLA, the Food and Drug Administration (FDA) is creating an advisory panel to deal with the spread of potentially deadly bacteria linked to contaminated duodenoscopes. The FDA Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee meets May 14-15 to examine the threat posed to patients by superbugs like carbapenem-resistant Enterobacteriaceae (CRE), which may lurk in these scopes and infect patients after endoscopic retrograde cholangiopancreatography (ERCP) procedures, according to the FDA. “FDA is convening this committee to seek expert scientific and clinical opinion related to reprocessing of duodenoscopes and other endoscopes, as well as automated endoscope reprocessors, based on available scientific information,” the agency said in its notice.

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The company that manufactured the endoscope linked to UCLA’s deadly superbug infections never obtained approval from the Food and Drug Administration (FDA) for the device, an agency official told CNN. Doctors use these scopes in more than 500,000 procedures annually, and a patient infected by the superbug scope is now suing the device maker. The scope in question, Olympus’ TJF-Q180V duodenoscope, is used routinely in a procedure called endoscopic retrograde cholangiopancreatography (ERCP) to diagnose or treat diseases of the liver, bile ducts and the pancreas, including types of cancer. Doctors insert the flexible snake-like device into the body through the throat or anus.

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The U.S. Food and Drug Administration (FDA) is warning doctors and consumers that a supplement used to treat genetic disorders in children can cause serious harm and in some cases could lead to death. New York-based compounding firm Medisca recently issued a voluntary recall of certain lot numbers of its L-citrulline products and warned consumers [...]

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The Food and Drug Administration (FDA) ordered testosterone drugmakers to add heart attack and stroke risk warnings to medication labels and also warned doctors against over-prescribing the medication. The agency announced recently that pharmaceutical companies must clarify that testosterone drugs are only approved for use in men with low testosterone caused by an injury or disease. They also must warn physicians and patients that the treatment is not without risks, that the medication may increase the risk of cardiovascular problems including heart attack and stroke. “FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging,” the agency said.

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Before reaching for a bottle of Tylenol, popping a DayQuil pill or downing a dose of Tylenol Cold and Flu this flu season, Americans should know these popular drugs and their generic counterparts may harm their liver. Acetaminophen effectively lowers fever and relieves minor aches and pains without stomach discomfort and heart issues associated with [...]

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Johnson & Johnson and subsidiary Janssen Pharmaceuticals face ongoing legal troubles with Risperdal after the drug giant was slapped with two multimillion dollar verdicts this week – one awarded to a family of a young man who claimed he grew breasts while on the drug and the other to South Carolina for marketing fraud. A Philadelphia jury awarded $2.5 million after finding J&J liable for the side effects suffered by plaintiff Austin Pledger and his family. The company was judged to have failed to warn that the medication could cause gynecomastia, a condition where young men and boys develop breasts.

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FDA officials will again review Pradaxa, one of the best-selling blood thinners on the market that is also linked to accidental, uncontrollable bleeding. The review by the U.S. Food and Drug Administration’s Mini-Sentinel initiative will compare post-trial results between Pradaxa (dabigatran), by drugmaker Boehringer Ingelheim, and its popular counterpart warfarin as a “one-time assessment of [...]

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An Oklahoma jury awarded $1.2 million to the family of a 96-year-old woman who was abused in a nursing home by two employees. Eryetha Mayberry’s three daughters filed a nursing home abuse lawsuit against Quail Creek Nursing Home and Rehabilitation Center in Oklahoma after hidden camera footage showed the elderly dementia patient’s caretakers manhandling her. The case reached federal court in Oklahoma City and judge announced the verdict on February 13. Daughter Doris Racher and her two sisters installed cameras in their mother’s room after they suspected someone at the home was stealing from her.

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The U.S. Food and Drug Administration in early January approved a new pill from Bristol-Meyers Squibb Co. and AstraZeneca to treat Type 2 diabetes after previously rejecting the drug. FDA officials last week announced Farxiga (dapaglifozin) can now be marketed and sold in the U.S. It’s the agency’s first new approval in 2014. The risk [...]

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