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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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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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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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FDA Advisory Committee Supports New Anticoagulant Drug Savaysa® (Edoxaban)

Forbes reports that the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-1 in favor of approval for Savaysa® (Edoxaban), an anticoagulant manufactured by Daiichi Sankyo. If approved by the FDA, this drug will become the fourth novel oral anticoagulant (NOAC) to receive FDA approval alongside Pradaxa, Xarelto, and Eliquis. Although the panel clearly supported […]

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Defense Verdict in First DePuy Pinnacle™ MDL Bellwether Case

Reuters reports that Johnson & Johnson was found not liable by a jury in the first federal  bellwether trial case in Texas over whether Pinnacle™ hip implants manufactured by DePuy were defective. The first bellwether trial in the DePuy Pinnacle™ Multidistrict Litigation (In Re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, MDL No. […]

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Xarelto® Lawsuit Update: Roger Denton Appears on Live Radio Show to Discuss Dangers of Xarelto®

On October 10, 2014, Roger Denton of Schlichter, Bogard & Denton, LLP appeared as a guest on the “Majority Report with Sam Seder” live radio show to discuss Xarelto®, a prescription anticoagulant that is the subject of recent lawsuits in the United States. Click here to listen to the segment. Denton explained that Xarelto® was […]

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FDA Remains Undecided Regarding the Potential Ban on Power Morcellators

The Democrat & Chronicle reports that the Food and Drug Administration (FDA) held hearings more than two months ago regarding the issue of whether to ban power morcellators. However, the FDA has yet to rule on the issue and affected families are outraged about the delay. FDA spokesperson Morgan Liscinsky provided, “The FDA is considering […]

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FDA Issues Drug Safety Communication regarding Health Risks for Asthma Drug Xolair®

On September 26, the FDA issued a Drug Safety Communication regarding the health risks of the asmtha drug Xolair® (omalizumab). In particular, the FDA warned that a 5-year safety study suggests a slightly increased risk of cardiovascular and cerebrovascular serious adverse events (as a result of heart and brain blood vessel problems) for patients being […]

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Class I Recall Issued by FDA for DePuy Synthes Craniomaxillofacial Distraction System

On August 28, 2014, the FDA notified healthcare professionals of a Class I Recall of the DePuy Synthes Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies). The FDA explained that “DePuy Synthes is recalling certain lots of the Craniomaxillofacial Distraction System because the device may reverse direction and lose the desired distraction […]

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