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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 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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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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EMA Agrees with FDA: Testosterone Therapy Drugs Not for Lifestyle Use

According to a recent report, the EMA has agreed with the FDA that the use of testosterone drugs should be reserved for men whose testosterone levels are low due to a medical condition. An EMA oversight committee said, “Testosterone levels naturally fall somewhat with age, but restoration of these levels in healthy older mean is […]

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Transvaginal Mesh Manufacturer Boston Scientific Sets Aside Nearly $1 Billion for Legal Expenses

In light of the ongoing lawsuits against Boston Scientific on behalf of women alleging severe injuries from their transvaginal mesh (TVM) devices, the 2006 acquisition of Guidant Corporation, and IRS tax issues, Boston Scientific has set aside nearly $1 Billion to pay legal expenses – as reported by the Boston Business Journal. According to the […]

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Testosterone Therapy (Low-T) Lawsuit Update: Direct Filing Order Entered in MDL 2545

On October 24, 2014, The Honorable Matthew F. Kennelly entered an Order allowing for the filing of federal complaints directly into the testosterone therapy multidistrict litigation (MDL 2545) pending in the United States District Court for the Northern District of Illinois. Kristine Kraft, a partner at Schlichter, Bogard & Denton, LLP, has been appointed by […]

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Xarelto® Lawsuit Update: JPML Hearing for Xarelto® (MDL 2592) Set for December

On December 4, 2014, a hearing before the Judicial Panel on Multidistrict Litigation (JPML) will take place in Charleston, South Carolina regarding the potential Xarelto® MDL (In re: Xarelto® Products Liability Litigation, MDL 2592). During this hearing, plaintiffs and defendants will present their arguments to the panel as to whether all federally-filed Xarelto cases should […]

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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 May Tighten Restrictions for Testosterone Drugs

CBS reports that the FDA Advisory Committee voted 20-1 that the product labels of popular testosterone drugs should be revised to clearly indicate that these drugs have not been shown to reverse common aging issues, including muscle loss and libido. Members of the Advisory Committee also unanimously agreed that evidence linking cardiovascular events and blood […]

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FDA Warns of Risk of Allergic Reactions from Active Ingredients in Certain Acne Treatment Products

ABC News reports that the FDA has warned of rare, but serious, allergic reactions to some active ingredients in over-the-counter acne treatments, including benzoyl peroxide and salicylic acid. In particular, the FDA issued a statement notifying that such topical, over-the-counter acne products containing these active ingredients can cause dangerous side effects, including life-threatening allergic reactions […]

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