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18 Apr 2012, 11:23 am
Closing Arguments Focus On Medical Issue Of Whether Or Not Fosamax Causes Osteonecrosis Of The Jaw (ONJ) (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Defense Verdict For Merck Ques #1: Did Mrs. [read post]
16 Apr 2012, 12:04 pm
QuarterWatch 2011 Quarter 2: More Pradaxa Adverse Events Reported Than Any Other Regularly Monitored Drug (Posted by Tom Lamb at DrugInjuryWatch.com) The developing drug safety controversy involving the anticoagulation drug Pradaxa (dabigatran) has been presented best, perhaps, by the ISMP QuarterWatch publication, which served as the basis for these two past articles about the problems with Pradaxa: (1) New Heart Drug Pradaxa May Be Sending "Early" Drug Safety… [read post]
10 Apr 2012, 1:15 pm
Beyaz, Safyral, Ocella, Gianvi, Zarah, Loryna, Syeda, And Vestura OC Pills Contain DRSP Progestin Also (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Bayer's "Dear Doctor" Letter about April 2012 label change (PDF) for its drospirenone (DRSP) birth control pills -- YAZ, Yasmin, Beyaz, and Safyral -- resulting from the December 8, 2011 FDA Advisory Committees meeting.… [read post]
4 Apr 2012, 2:10 pm
Neither Recent Nor Past Use Of These Antibiotics In Fluoroquinolones Class Was Related To Retinal Detachment (Posted by Tom Lamb at DrugInjuryWatch.com) Patients taking oral antibiotics known as fluoroquinolones such as Cipro (ciprofloxacin) and Levaquin (levofloxacin) are at an increased risk for developing a detached retina, an eye injury which can lead to permanent blindness if not medically treated in a timely manner. [read post]
29 Mar 2012, 12:10 pm
Mensing, Some Momentum Builds For (Once Again) Allowing Drug Injury Lawsuits On All Prescription Medications, Generic As Well As Brand Name (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: Introduction of the “Patient Safety and Generic Labeling Improvement Act” legislation in late April 2012 The Senate bill, S. 2295, was introduced by the Chairman of the Judiciary Committee, Senator… [read post]
25 Mar 2012, 10:57 pm
The D&O Diary is on assignment in the British Isles this week, with the first stop on the itinerary in London. [read post]
22 Mar 2012, 1:15 pm
New Case Report About Routine Fall Involving An Elderly Patient That Results In Fatal Irreversible Brain Hemorrhage (Posted by Tom Lamb at DrugInjuryWatch.com) Pradaxa® is the name under which Boehringer Ingelheim Pharmaceuticals, Inc. markets a prescription anticoagulant medication generically called dabigatran. [read post]
15 Mar 2012, 11:40 am
820 Cases Are Filed In Federal Court NuvaRing MDL And 125 Lawsuits Are Part Of New Jersey State Court Mass Tort (Posted by Tom Lamb at DrugInjuryWatch.com) The following information about the number of NuvaRing lawsuits that had been filed before January 2012 comes from page 119 of the Merck & Co., Inc. [read post]
9 Mar 2012, 3:06 pm
Jury Is Told Numerous Times By Her Attorney That Fosamax Did Nothing For Sessner, It Only Did Something To Her (Posted by Tom Lamb at DrugInjuryWatch.com) During his March 5, 2012 opening statement the plaintiff's attorney, Tim O'Brien, told members of the jury numerous times that Fosamax did nothing for Jo Ann Sessner, it only did something to her. [read post]
8 Mar 2012, 2:16 pm
Federal Court NuvaRing MDL Bellwether Trial Dates Pushed Back Several Times Previously; Perhaps It Will Be Late 2012 (Posted by Tom Lamb at DrugInjuryWatch.com) The first NuvaRing lawsuit has been scheduled to start trial in February 2013 pursuant to In Re: NuvaRing Litigation Case Management Order (CMO) #19. [read post]
5 Mar 2012, 1:05 pm
Prescriber Error, Impaired Renal Function, Patient Age, And Lack Of An Effective Reversal Agent Are Cited (Posted by Tom Lamb at DrugInjuryWatch.com) A Letter to The Editor, titled "Bleeding Risk with Dabigatran in the Frail Elderly" (subscription required), which appeared in the March 1, 2012 edition of the New England Journal of Medicine (NEJM) may help explain when and why there is a serious bleeding risk associated with Pradaxa (dabigatran). [read post]
28 Feb 2012, 1:11 pm
Bayer 2011 Annual Report: Settlement Agreements: 70 Cases Settled As of Mid-February 2012; Negotiations Will Continue On Case-by-Case Basis (Posted by Tom Lamb at DrugInjuryWatch.com) From February 1, 2011 to February 1, 2012 the number of lawsuits in the U.S. served upon Bayer involving side effects allegedly from the use of Bayer’s oral contraceptive products Yasmin™ and/or YAZ™ or from the use of Ocella™ and/or Gianvi™ has increased from… [read post]
24 Feb 2012, 2:08 pm
The Flores Case And The Sessner Case Involve Incidents Of ONJ Jaw Injury, Not The Femur Fracture Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: During pretrial hearings Judge Higbee severed the Flores case from the Sessner case. [read post]
Yasmin / Safyral / Beyaz: February 2012 Label Change Non-Specific To These Bayer Birth Control Pills
17 Feb 2012, 12:52 pm
Same General Warning About All COCs Was Added To YAZ In March 2011; And Why The One Year Delay, We Wonder (Posted by Tom Lamb at DrugInjuryWatch.com) The February 14, 2012 email captioned "What's New on the FDA Drugs Site" let us know that there was a new version of the Package Insert for Yasmin, Safyral, and Beyaz which consisted of four new sentences being added to the WARNINGS AND PRECAUTIONS section: 5.1 Thromboembolic Disorders and Other Vascular Problems… [read post]
10 Feb 2012, 10:38 am
At Increased Risk Are Patients Who Are Older, Have Altered Renal Clearance, Or Undergoing Atrial Fibrillation (AF) Ablation (Posted by Tom Lamb at DrugInjuryWatch.com) We first reported about Pradaxa (dabigatran) back in October 2011 in this article "New Heart Drug Pradaxa May Be Sending "Early" Drug Safety Signals". [read post]
6 Feb 2012, 2:17 pm
Reason Is That Bayer Has Been Supplying Teva And Barr With The Product For Their Gianvi Pills Since December 2010 (Agreement Is Similar To Ocella Deal) (Posted by Tom Lamb at DrugInjuryWatch.com) Gianvi, a generic version of YAZ, is marketed by Teva Pharmaceuticals and Barr Laboratories, which are commonly referred to as generic drug companies. [read post]
30 Jan 2012, 2:06 pm
"Significant Safety Concern": Higher Death Rate For Doribax In Ventilator-Associated Pneumonia When Compared To Patients Receiving Imipenem Therapy (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "Doribax (doripenem for injection) - Higher Mortality Rate and a Lower Clinical Cure Rate Observed During a Comparative Clinical Trial - Notice to Hospitals" [Health Canada,… [read post]
23 Jan 2012, 12:11 pm
11 Of The 26 FDA Panel Members Voted There Were No Sufficient Unique Benefits For YAZ / Yasmin That Cannot Be Found In Other Hormonal Contraceptives (Posted by Tom Lamb at DrugInjuryWatch.com)On December 8, 2011 the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee held a joint meeting to discuss YAZ and Yasmin as well as several other relatively new birth control pills. [read post]
16 Jan 2012, 12:35 pm
FDA Reviewing Serious Side Effects Associated With Pradaxa Ranging From Heart Attacks To Serious Bleeding or Hemorrhages (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Pradaxa label change: This January 17, 2012 FDA approval letter shows the revisions being made to current label. (1/19/12) ______________________________________________________________________________ Patients who use… [read post]
5 Jan 2012, 1:16 pm
Ten Strategies Intended For Pharmacists Can Help Patients Stay Safe, Also (Posted by Tom Lamb at DrugInjuryWatch.com) It is relatively well-accepted in the healthcare community that medication errors involving prescription drugs happen more often than they should but the incident rate could be reduced if both pharmacists and patients took certain precautions. [read post]
