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Xarelto Expanded Use Denied Again by FDA

According to Reuters, the FDA once again declined to approve wider uses of the prescription drug Xarelto® (Rivaroxaban) late last month. Currently, the drug’s biggest approved use is to prevent blood clots and strokes in patients with an irregular heartbeat called atrial fibrillation. Recently, the drug’s co-marketers—Bayer AG and Johnson & Johnson—tried to expand the drug’s […]

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Risperdal: $2.5 Million Verdict for Plaintiff in Philadelphia State Court

Philadelphia Daily News reports that a Philadelphia jury has awarded a 20 year old autistic man, Austin Pledger, $2.5 million after he developed size 46 DD breasts (a condition referred to as gynecomastia) as a young teenager after using the antipsychotic drug Risperdal. In particular, the jury found that the manufacturer, Johnson & Johnson, failed […]

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FDA Requires New Labeling Change for Testosterone Drugs Regarding Increased Risk of Heart Attack and Stroke

On March 3, 2015, the Food and Drug Administration (FDA) issued a Safety Announcement cautioning that testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions, rather than due to aging. The FDA also required manufacturers of testosterone drugs to clarify the approved uses of these medications and […]

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Pfizer Agrees to $400 Million Settlement in Class-Action Securities Lawsuit Involving Investors

The Wall Street Journal reports that Pfizer has agreed to pay $400 million to settle a class-action securities lawsuit alleging that the company illegally marketed several medications causing its investors to lose money, according to a filing with the United States Securities and Exchange Commission (SEC). The securities lawsuit alleged that Pfizer marketed several drugs […]

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Xarelto® Litigation Update: Mass Tort Created in Philadelphia State Court

On January 21, Administrative Judge Kevin Dougherty of the Philadelphia Court of Common Pleas issued an Order transferring Xarelto cases currently on file in Philadelphia state court to the court’s mass tort docket for coordination. The cases will be transferred to the court’s Complex Litigation Center for further management. Plaintiffs allege that Xarelto® was introduced […]

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FDA Approves New Blood Thinning Medication Savaysa (Edoxaban)

The FDA announced that it has approved Savaysa (edoxaban), an anti-clotting drug manufactured by Tokyo-based Daiichi Sankyo and used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problems. Savaysa has also been approved by the FDA to treat […]

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Daiichi Sankyo Pays $39 Million to Settle False Claims Act Lawsuit

Law 360 reports that Daiichi Sankyo Inc., a Japanese pharmaceutical giant, has agreed to pay $39 million to the Massachusetts government and state Medicaid problems in order to settle a False Claims Act (FCA) lawsuit alleging that the company paid kickbacks to physicians to encourage prescriptions of the company’s cholesterol and blood pressure medications (U.S. […]

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FDA Requires Black Box Warning for Power Morcellators

The Wall Street Journal reports that the Food and Drug Administration (FDA) has called for an immediate ‘Black Box Warning’ for power morcellators, which is “the strongest caution the agency issues.” William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said, “We believe that in the vast […]

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FDA Warns of Rare, But Potentially Fatal, Skin Reactions with Ziprasidone

On December 11, 2014, the Food and Drug Administration (FDA) issued a Drug Safety Communication warning that the antipsychotic drug Ziprasidone (brand name, Geodon), which is used to treat schizophrenia and bipolar disorder, is associated with rare, but potentially fatal, serious skin reactions that can affect other parts of the body. The FDA reports that […]

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Gynecologists Continue Using Power Morcellators Despite FDA Warning, The Wall Street Journal Reports

The Wall Street Journal reports that doctors nationwide are continuing to use a popular surgical tool, known as power morcellators, even after the United States Food and Drug Administration (FDA) warned that the device can spread undetected cancer. The Wall Street Journal notes that this demonstrates “the limits of the regulator’s reach into clinical practice.” In […]

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