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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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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 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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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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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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Testosterone Lawsuit Update: FDA Advisory Committee Decides Further Study of Cardiovascular Risks Required

Bloomberg News reports that the members of a Food and Drug Administration (FDA) Advisory Committee unanimously agreed this week that manufacturers of testosterone drugs should further study the potential cardiovascular health risks of testosterone products and who should take these drugs. According to the FDA, the Advisory Committee Meeting was held on September 17, 2014 […]

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