The FDA has issued citations to 10 manufacturers of dimethylamylamine, more commonly known as DMAA. One of those manufacturers is USP Labs, LLC, the manufacturer of Oxy Elite Pro and Jack3D. The FDA warnings stem from a violation of the Dietary Supplement Health and Education Act of 1994 (DSHEA). This act requires that manufacturers of
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According to an FDA review of biphosphonates published in the New England Journal of Medicine, long term use of these drugs, commonly known as Boniva or Fosamax, could lead to weakened bones. In these cases women suffered very serious Fosamax side effects including unusual femur fractures and osteonecrosis of the jawbones. The FDA now questions
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The manufacturer of Depakote, Abbott Laboratories, has reached an agreement to pay out 1.6 billion dollars “for its criminal and civil liability arising from the company’s illegal promotion of the prescription drug Depakote for uses not approved as safe and effective by the Food and Drug Administration” according to a press release from the Department
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More cases against Bayer, maker of Yaz and Yasmin, have begun to settle. Currently 651 cases have settled, which averages around $218,000 per case, where women suffered from life threatening blood clots, according to Bloomberg News. Thousands more cases await trial or settlement and until April 10th the drug did not have a heightened warning
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In the case known as U.S. ex rel. Helen Ge v. Takeda Pharmaceutical Co. the maker of Actos is under fire for trying to influence the medical reviewers of the drug to “change their professional opinions” when reviewers found that there were heart problems associated with the use of Actos. Ge brought suit under the
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On April 20, 2012, the U.S. Food and Drug Administration (FDA) issued a Safety Communication adding new warnings and new contraindications associated with the use of blood pressure medications containing aliskiren, which is the active ingredient in Tekturna. Tekturna side effects include stroke and kidney failure. The new warnings include risks when using Tekturna with
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On May 1, 2012, U. S. District Judge Joseph R. Goodwin, the presiding judge for all federal transvaginal mesh lawsuits against C.R. Bard Inc., issued an Order scheduling the first bellwether trial in MDL 2187 to begin February 5, 2013. MDLs, multidistrict litigation cases, involve the consolidation of lawsuits filed in federal courts across the
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Bayer continues to settle Yaz/Yasmin birth control lawsuits involving blood clots that caused deep vein thrombosis or pulmonary embolism. Bayer reported in its 1st quarter Stockholders’ Newsletter 2012 that it reached an agreement to settle the claims of 651 plaintiffs for a total amount of $142 million, for an average of $218,000 a case. This
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The U.S. Food and Drug Administration (FDA) delayed its approval on a new diabetes medication, alogliptin, requesting additional data from the manufacturers. Japan’s Takeda Pharmaceutical Co Ltd (Takeda) has been trying to obtain FDA approval for several years on what the company hopes will be the successor to its top-selling diabetes drug, Actos. In June
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On April 16, 2012 Health Canada warned diabetes patients of the increased risk of developing bladder cancer associated with the diabetes drug, Actos (pioglitazone). Takeda Canada, the Canadian manufacturer of Actos, joined Health Canada in issuing the safety communication, confirming the link of Actos with bladder cancer. The Actos warning comes as no surprise to
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