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24 Apr 2012, 1:04 pm
Recent Medical Article And Poster Presentation Both Point To A Trend Toward Increased Rate Or Risk Of Myocardial Infarction (MI) (Posted by Tom Lamb at DrugInjuryWatch.com) A recent "position paper" by a group of experts from the European Society of Cardiology (ESC) Working Group on Thrombosis provides an update on the side effects associated with Pradaxa (dabigatran). [read post]
4 Apr 2011, 1:15 pm
Merck ONJ Trial Set For May 2011 (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________UPDATE: On May 23, 2011 the U.S. [read post]
8 Mar 2011, 7:54 am
Oral Clefts In Babies Are 20 Times More Likely With Women Who Used Topamax (topiramate) After Getting Pregnant (Posted by Tom Lamb at DrugInjuryWatch.com) In early March 2011 the FDA announced that the prescribing information for Topamax and generic topiramate products would be changed to warn women and their doctors about an increased risk of oral cleft birth defects in children whose mothers used these epilepsy and migraine drugs during pregnancy. [read post]
12 May 2009, 6:55 am
These New Cases Involve Premixed IV Bags of Heparin And Initial Tests Did Not Detect Oversulfated Chondroitin Sulfate Contamination (Posted by Tom Lamb at DrugInjuryWatch.com) The headline used by the Wall Street Journal (WSJ), "Heparin Stirs New Fears", alluded to last year's heparin-illness outbreak when roughly 80 deaths were linked to contaminated heparin and led to a recall of the medicine from several companies. [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]
9 May 2011, 2:13 pm
One Sees Mixed Findings About These Fosamax Side Effects From Various Research Reports And Case Studies (Posted by Tom Lamb at DrugInjuryWatch.com) Last month we wrote about the status of the thousands of Fosamax lawsuits that have been filed against Merck alleging that the use of this bisphosphonate drug by osteoporosis patients resulted in either atypical low-stress femur fractures or osteonecrosis of the jaw, commonly called ONJ. [read post]
8 Sep 2011, 11:04 am
Osteonecrosis Of The Jaw, Or Jawbone Death, And Atypical Femur Fractures, Or Low-Stress Thigh Bone Breaks, Are The Primary Drug-Safety Issues (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Warner, Merck Bone Drugs Need Label Changes on Use Duration, Panel Says (9/9/11, Bloomberg) FDA Panel: Osteoporosis Drugs Need Better Labels (9/9/11, WebMD Health News)Time Limits on the Drugs Are… [read post]
31 Jul 2012, 12:03 pm
Almost 2,000 Lawsuits With Blood Clots Such As DVT And PE Settled, With At Least Another 4,000 Such Cases In Settlement Mediation Negotiations (Posted by Tom Lamb at DrugInjuryWatch.com) From Bayer's Stockholders' Newsletter Second Quarter 2012 (PDF format), at page 50, we get the following update on the Gianvi / Ocella / Yasmin / YAZ litigation: As of July 19, 2012, the number of lawsuits pending in the United States and served upon Bayer was about 12,325 involving… [read post]
28 Apr 2008, 9:03 am
After Their Medications Get Approved By FDA, Many Drug Companies Have Not Yet Started The Studies Which They Promised To Do (Posted by Tom Lamb at DrugInjuryWatch.com) Each year the FDA issues what could be called a "report card" on how the pharmaceutical companies are doing as regards post-approval studies for their products that have been approved for sale in the U.S. [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]
21 Jan 2008, 2:50 pm
Pfizer Increases Warning About Abnormal Behavior Of Patients Using Its Smoking Cessation Medication In January 2008 (Posted by Tom Lamb at DrugInjuryWatch.com) On November 20, 2007 the FDA issued an "Early Communication About an Ongoing Safety Review Varenicline (marketed as Chantix)" to inform healthcare providers about reports the agency had received of people exhibiting various types of abnormal behaviors while using Chantix. [read post]
8 Feb 2011, 11:25 am
In Addition To The Federal Court Fosamax Jaw Injury Lawsuits Set For Trial In March 2011 And May 2011 (Posted by Tom Lamb at DrugInjuryWatch.com)_____________________________________________________________________ UPDATE: Order by Federal Court Fosamax MDL Judge John F. [read post]
1 Dec 2011, 2:02 pm
Coincidence, But Ironic, Given Several Recent Medical Studies Which Suggest Drospirenone (DRSP) Causes Blood Clots (Posted by Tom Lamb at DrugInjuryWatch.com) On November 29, 2011 Watson Pharmaceuticals issued this press release, "Watson's Generic Yaz(R) Receives FDA Approval", which begins as follows: Watson Pharmaceuticals, Inc. [read post]
19 Jan 2008, 3:29 pm
Label For "The Patch" No Longer Has Conflicting Information About Its Increased Risk Of Blood Clots (Posted by Tom Lamb at DrugInjuryWatch.com) A January 18, 2008 WebMD article, "Stronger Warning for Birth Control Patch", provided a concise summary of the latest news about the Ortho Evra Contraceptive Transdermal (Skin) Patch manufactured by Ortho-McNeil Pharmaceuticals, a division of Johnson & Johnson (JNJ):The FDA today strengthened… [read post]
6 Dec 2011, 8:55 am
Expert Reports From YAZ / Yasmin Lawsuits Will Not Be Considered Because Submitted After Deadline Set By FDA (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: "Bayer Birth Control Pill Benefits Outweigh Risks, Panel Says" (12/8/11, Bloomberg) (12/12/11) _____________________________________________________________________ In October 2011 the FDA released its new drug-safety study report,… [read post]
13 Oct 2008, 9:59 pm
(Posted by Tom Lamb at DrugInjuryWatch.com) In the first part of October 2008 we learned of yet another instance where a drug company chose to put profits over people. [read post]
13 Dec 2007, 10:16 am
Serious Adverse Reactions With This Vaginal Ring Birth Control Device Include Deep Vein Thrombosis (DVT) And Pulmonary Emboli (PE) (Posted by Tom Lamb at DrugInjuryWatch.com) An abstract from the annual meeting of the American Society of Hematology (ASH) entitled "Venous Thromboembolic Events in Women Using the NuvaRing ®. [read post]
24 Nov 2010, 10:57 am
Johnson and Johnson: Man Ruptured Achilles Tendons In Both Feet After Taking Levaquin (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________________ UPDATES: "J&J Loses First Trial on Warnings of Levaquin Risk" (12/8/10, Bloomberg) "Johnson & Johnson Warned on Levaquin Risk, Lawyer Says [During Closing Argument]" (12/6/10, Bloomberg) "Schedin v. [read post]
20 Aug 2012, 11:15 am
This Pradaxa MDL Case Will Include Gastrointestinal Bleeding And Other Hemorrhages As Well As Heart Attacks Or Myocardial Infarctions (Posted by Tom Lamb at DrugInjuryWatch.com) Pradaxa is a blood-thinning drug used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. [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]
