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Following up on an earlier blog post, Harman Law LLC is following a story about a 45-year-old man who took Tecfidera (dimethyl fumarate) for three weeks. He experienced extensive bilateral deep venous thrombosis extending from calf veins to deep femoral veins. Fortunately, the man’s DVT abated after receiving anticoagulation treatment. Tecfidera was approved by the… Continue reading
Covidien Components of Defibrillators May Cause Organ Failure, Strokes or Death The FDA has issued a Class 1 safety alert for the electrodes used in defibrillator medical devices listed below. A Class 1 alert is the most serious issued by the FDA. The concern is that devices using Covidien electrodes may delay or fail to… Continue reading
Asthma Drug Under Scrutiny The Food and Drug Administration issued a Safety Announcement warning that the asthma drug Xolair® increases the risk of heart attack, stroke, chest pain, and blood clots, among other serious problems. Xolair® is an injectable drug that was approved in 2003 to treat moderate to severe asthma in adults and children 12… Continue reading
Jeep Cherokee and Dodge Durango models in recall for defective wiring and potential fire risk After an investigation by the National Highway Traffic Safety Administration (NHTSA), Chrysler has been forced to recall almost 895,000 sport utility vehicles. The recall covers Jeep Grand Cherokee and Dodge Durango models manufactured between 2011 and 2014. The affected models… Continue reading
The FDA issued a drug safety alert that the agency is requiring the manufacturer of the antibiotic Levaquin (levofloxacin) and Avelox (moxifloxacin) to revise the labeling to warn patients of the risk of serious side effects including antibiotic nerve damage. Previously, these drugs were implicated in tendon tears and ruptures in the arms and legs,… Continue reading
Pharmacy Errors Under Scrutiny An article yesterday in the Legal Intelligencer newspaper says that pharmacy errors are on the rise and patient safety is at risk. The sheer increase in the number of people taking prescription drugs alongside the rapid development of pharmacies in every community may in part be a factor, but attorney Brandon… Continue reading
Researchers Issue New Warnings About 500 sunscreen products on the market this year that contain sunscreen have been found to either not work as well as advertised, or may contain ingredients that could be toxic according to a recent article in The Columbus Dispatch newspaper. Researchers at the Environmental Working Group said many of the… Continue reading
Concerns prompt FDA to issue additional safety alert The FDA issued a “Safety Communication” May 6, 2014 regarding the potential for harm to patients from a small, cage-like medical device implanted in blood veins. The device, the Interior Vena Cava (IVC) filter, is used in patients at risk of developing blood clots or embolisms anywhere… Continue reading
Pharma-Psychiatry Connection & the Legal Fallout on Tonight’s The American Law Journal The American Psychiatric Association’s new “Choosing Wisely” program admonishes doctors for prescribing psychotropic drugs for children and the elderly too quickly. Do brand name drugs going generic- and lawyers- have something to do with this? Tonight at 7:00 pm (March 31) on the… Continue reading
Followup to December 2013 Class 1 recall of the HeartWare, Inc. Heartware Ventricular Assist System In December of last year, the FDA issued its most serious recall, Class 1, for the HeartWare, Inc. “Heartware Ventricular Assist System” pump mechanism. The manufacturer followed up yesterday by reissuing a warning to physicians following additional reports of device… Continue reading
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