FDA Approves New Anticoagulation Reversal Agent and Boehringer Ingelheim Updates Pradaxa Label
The U.S. Food and Drug Administration (FDA) recently approved a reversal agent to be used in patients experiencing serious and uncontrollable bleeding. The anticoagulation reversal agent is called Kcentra, a product developed and manufactured by CSL Behring. The new treatment counteracts the effects of vitamin K antagonist (VKA) anticoagulation, which could be triggered by the use of an anticoagulant medicine such as Pradaxa or warfarin. The advantage of Kcentra is healthcare providers do not have to thaw the reversal agent, as they commonly do with plasma treatments, nor do Continue Reading
Pradaxa Timeline: Carey Danis & Lowe Pradaxa Lawyers Chronicle Pradaxa Bleeding Risk
August 15, 2009 – Boehringer Ingelheim researchers submitted Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial data to The New England Journal of Medicine October 19, 2010 – Pradaxa approved by FDA to prevent stroke in patients with atrial fibrillation. December 2011 – FDA announced an investigation into a significant number of reports linking episodes of serious, uncontrollable bleeding with Pradaxa use. November 2012 – FDA released another opinion on the safety of Pradaxa following an FDA evaluation of Pradaxa bleeding events recorded via the FDA’s Sentinel Initiative Mini-Sentinel Continue Reading
New Pradaxa Analysis Underscores Pradaxa Deaths and Urgency of Further Pradaxa Safety Investigations
In January, the Institute for Safe Medication Practices (ISMP) released a report with their safety analysis of three anticoagulant medications, including Pradaxa, warfarin, and Xarelto. The ISMP found that approximately 1,734 adverse event reports were submitted to the U.S. Food and Drug Administration (FDA) in quarter 2 of 2012 for the anticoagulant drugs warfarin, Pradaxa, and Xarelto. Of those adverse event reports, around 233 detail patient deaths linked to use of these three anticoagulant medications. These numbers led the ISMP to conclude that anticoagulant medications in general pose a Continue Reading
Australian Topamax Study Links Anti-Epileptic Drug to Birth Defects
A study published in early March by a team of Australian researchers establishes a strong link between Topamax and congenital birth defects. The study was conducted by the Department of Medicine and Neurosciences at the Royal Melbourne Hospital and by the University of Melbourne. In their study, the Australian research team discovered a link between exposure to Topamax in the womb and the development of hypospadias and problems with proper brain development. Topamax has been firmly connected to the birth defects known as oral clefts, such as cleft lips Continue Reading
Carey Danis & Lowe Examines FDA Pradaxa Safety Review
Submit Your Claim The U.S. Food and Drug Administration (FDA) recently published a report about the safety of Pradaxa in The New England Journal of Medicine. The article’s intention was to more thoroughly examine the health risks associated with Pradaxa use, especially in light of the increasing reports linking Pradaxa to excessive bleeding and death. The study that won Pradaxa FDA approval in October 2010, the Randomized Evaluation of Long-Term Anticoagulation Therapy, or RE-LY, trial compared Pradaxa to warfarin. The RE-LY trial results concluded there to be no difference Continue Reading
FDA Sends Stryker Warning Letter about Negligent Business Practices
Submit Your Claim According to a Reuters report published on March 12, the U.S. Food and Drug Administration (FDA) has sent Stryker a warning letter about its business practices and its marketing strategy. The letter follows a visit by the FDA to a Styrker plant in November 2012. The FDA visited a Stryker plant in Portage, Michigan to conduct an inspection, and discovered that Stryker, the manufacturer of orthopedic implants, had been marketing implants without FDA approval. Furthermore, Stryker had also recalled one of their products without communicating this Continue Reading
First Actos Trial is Cooper v. Takeda Pharmaceuticals America Inc.
Submit Your Claim The first Actos lawsuit has gone to trial in a California Superior Court in Los Angeles, known as Cooper v. Takeda Pharmaceuticals America Inc. Cooper v. Takeda is being heard by Judge Kenneth Freeman in California. The plaintiff in the case claims that Takeda failed to warn that one of the risks connected to the diabetes drug is bladder cancer. To date, there are over 3,000 Actos bladder cancer lawsuits that have been filed against Takeda across the United States in states like California, Illinois, and Continue Reading
Lawyers at Carey Danis & Lowe Currently Evaluating Mirena Cases
Submit Your Claim Published February 20, 2013 by PR Web St. Louis, Missouri (PRWEB) February 20, 2013 To address the increasing number of adverse event reports associated with the use of the Mirena intrauterine device manufactured by Bayer(1), lawyers at Carey Danis & Lowe have launched a new website with useful information for individuals who may have used the Mirena IUD or know someone who has used the contraceptive device. The new webpage has information about health complications associated with use of Bayer’s Mirena IUD. In Carey Danis & Continue Reading
Carey Danis & Lowe Currently Evaluating Mirena Lawsuits: Lawyers Accepting Mirena Cases
Submit Your Claim Lawyers at Carey Danis & Lowe have been closely following recent news regarding Mirena lawsuits. Following growing adverse event reports filed with the U.S. Food and Drug Administration (FDA) as well as increasing numbers of Mirena lawsuits being filed across the country, Lawyers at Carey Danis & Lowe are currently offering free legal evaluations of Mirena cases. Manufactured by Bayer Healthcare Pharmaceuticals Inc. (Bayer), Mirena is a contraceptive device intended for long-term use of up to 5 years, and is recommended for use by women who Continue Reading
Takeda Pharmaceuticals Releases New Diabetes Drug with Bladder Cancer Causing Pioglitazone
Submit Your Claim The manufacturer of the diabetes drug Actos, a drug that is tied up in mounting complaints and lawsuits citing the development of bladder cancer, has received U.S. Food and Drug Administration (FDA) approval for a new diabetes drug known generically as alogliptin. The FDA approved three new alogliptin combination drugs for the treatment of type 2 diabetes along with an adjusted diet and exercise regimen. Takeda has announced that it will release the three drug combinations onto the market beginning in the summer of 2013. Takeda Continue Reading
