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6 Sep 2007, 2:56 pm
Antibiotic Ketek Restricted To Certain Types Of Pneumonia; No Longer Used For Sinusitis, Bronchitis, Tonsillitis, Pharyngitis (Posted by Tom Lamb at DrugInjuryWatch.com) On September 5, 2007 Health Canada issued by email a MedEffect alert about Ketek which included this summary:Sanofi-aventis Canada, Inc. is informing Canadians that the antibiotic Ketek (telithromycin), should no longer be used to treat sinusitis, bronchitis, tonsillitis or pharyngitis. [read post]
16 Sep 2009, 1:38 pm
August 2009 FDA Warning Letter Sent To Bayer Relates To Quality Control Problems Found In March 2009 At German Facility Where DRSP Was Made (Posted by Tom Lamb at DrugInjuryWatch.com) By means of a September 15, 2009 Associated Press (AP) news article, "FDA Warns Bayer Over German Manufacturing Plant", we first learned about a Warning Letter sent by the FDA back on August 5, 2009. [read post]
5 Mar 2009, 10:22 am
March 2009 Drug Safety Update Newsletter (UK) Raises Emerging Safety Issue Of Kidney-Related Side Effects From Byetta Use (Posted by Tom Lamb at DrugInjuryWatch.com) We last reported on Byetta (exenatide) in August 2008, when the FDA issued a MedWatch email alert about six new cases of hemorrhagic pancreatitis and necrotizing pancreatitis that had been reported to FDA since an October 2007 "Dear Doctor" letter about Byetta and acute pancreatitis was sent to doctors in… [read post]
5 Jun 2012, 2:35 pm by Tom Lamb
Pradaxa Adverse Reactions And Serious Bleeding Events More Common In Older Patients And Females, With Reduced Renal Function Also Being A Factor (Posted by Tom Lamb at DrugInjuryWatch.com) In April 2012 the manufacturer of Pradaxa (dabigatran), Boehringer Ingelheim, announced it is launching the GLORIA TM-AF Registry Program, which is designed to gather real-world data on patient demographics, disease characteristics, treatment decisions, and the safety and efficacy of Pradaxa as… [read post]
16 Jun 2008, 1:58 pm
Recall Now Covers 30 mg And 60 mg Tablets Made During June 2006 To May 2008 Period Due To The Potential For Oversized Tablets (Posted by Tom Lamb at DrugInjuryWatch.com) As we reported recently, on June 10, 2008 the FDA issued a MedWatch Email Alert, "Morphine Sulfate 60 mg Extended Release Tablets - Recall of a Single Lot Due to a Report of a Tablet With Twice the Appropriate Thickness". [read post]
9 May 2012, 12:51 pm by Tom Lamb
825 Lawsuits Are Part Of New Jersey State Court Mass Tort Consolidation; Majority Of Other Cases Are Filed In "Second" Fosamax Federal Court MDL (Posted by Tom Lamb at DrugInjuryWatch.com) The following information about the number of Fosamax - femur fracture lawsuits that had been filed before January 2012 comes from pages 117-118 of the Merck & Co., Inc. [read post]
23 Feb 2010, 1:34 pm by Tom Lamb
Heart Risk Is Current Focus Due To GlaxoSmithKline Past Conduct; But Public Citizen Has Pointed The Liver Failure Case Reports Linked To Avandia, Also(Posted by Tom Lamb at DrugInjuryWatch.com) As some of you may recall, in October 2008 Public Citizen petitioned the FDA to ban the sale of the diabetes drug Avandia (rosiglitazone) in the U.S. because its risks, which include heart attack and heart failure in addition to liver toxicity, far outweigh its benefits and because much… [read post]
7 Dec 2011, 5:16 am by Tom Lamb
J&J Birth Control Patch Ortho Evra Safety Review Will Focus On Blood Clot Side Effects Like Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT) (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE:  Transcript for the December 9, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee  (PDF - 685KB) Minutes for the… [read post]
10 Dec 2008, 10:21 pm
Currently Print Drug Ads Are Required To Show Information  So That Patients  Can Report Serious Side Effects To FDA MedWatch Program (Posted by Tom Lamb at DrugInjuryWatch.com) A November 25, 2008 Associated Press (AP) article, "FDA to study phone number to report side effects",  let  us know about  an issue that the FDA will be considering, soon:   Whether television drug advertisements should urge… [read post]
11 Jun 2009, 1:58 pm
In Europe Reports Of Pulmonary Embolism And Deep Vein Thrombosis Were Made Soon After Yasmin Birth Control Pill Was Approved In 2000 (Posted by Tom Lamb at DrugInjuryWatch.com) An April 13, 2002 BMJ article, "Dutch GPs warned against new contraceptive pill" (FREE registration required), was published the week before the Yasmin birth control pill was going to become available to women in the United Kingdom. [read post]
6 Feb 2012, 2:17 pm by Tom Lamb
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]
16 Jul 2009, 3:13 pm
July 2009 Liver Transplantation Article  Reports  The Findings And Accompanying Editorial Makes The  Recommendations (Posted by Tom Lamb at DrugInjuryWatch.com) In its July 2009 edition the medical journal Liver Transplantation published an article that provides an overview of the current situation concerning drug-induced acute liver failure (DIALF) in the U.S. and an editorial that makes some recommendations about how we might improve that… [read post]
18 Feb 2008, 8:45 am
Delay By Bayer And FDA Until November 2007, When Trasylol Sales Were "Suspended", Caused 22,000 Excess Deaths Per CBS Report (Posted by Tom Lamb at DrugInjuryWatch.com) According to interviews broadcast by CBS Television's 60 Minutes program about Trasylol on February 17, 2008, an estimated 22,000 patient lives could have been saved if the FDA had acted quicker to recall Trasylol, Bayer AG's drug used to stem bleeding during open heart surgery. [read post]
5 Jun 2012, 2:35 pm by Tom Lamb
Pradaxa Adverse Reactions And Serious Bleeding Events More Common In Older Patients And Females, With Reduced Renal Function Also Being A Factor (Posted by Tom Lamb at DrugInjuryWatch.com) In April 2012 the manufacturer of Pradaxa (dabigatran), Boehringer Ingelheim, announced it is launching the GLORIA TM-AF Registry Program, which is designed to gather real-world data on patient demographics, disease characteristics, treatment decisions, and the safety and efficacy of Pradaxa as… [read post]
15 Oct 2012, 1:58 pm by Tom Lamb
People Who Suffer These Atypical Femoral Fractures Are Well Treated With This Surgical Procedure Using Rod-Like Nail, With Low Rate Of Complications (Posted by Tom Lamb at DrugInjuryWatch.com) According a recent article about a presentation -- Clinical and functional outcomes in patients who sustained bisphosphonate-associated complete femur fractures. [read post]
31 Jul 2009, 11:45 am
(Posted by Tom Lamb at DrugInjuryWatch.com) In October 2008 Public Citizen petitioned the FDA to ban the sale of the diabetes drug Avandia (rosiglitazone) in the U.S. because its risks, which include heart attack and heart failure in addition to liver toxicity, far outweigh its benefits and because much safer alternatives exist for treating Type 2 diabetes. [read post]
28 Feb 2012, 1:11 pm by Tom Lamb
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 6,850 (source: Bayer Annual… [read post]
7 Dec 2007, 12:08 pm
Agency's Follow-Up On Its August 2007 "Early Communication" About These Heartburn Drugs Is Late, But Just In Time For Christmas Dinner (Posted by Tom Lamb at DrugInjuryWatch.com) As reported previously, in early August 2007 the FDA and Health Canada raised concerns about possible serious cardiac events in patients using Nexium and Prilosec, made by AstraZeneca (AZN), which are used for the treatment of gastroesophageal reflux disease (GERD) and esophageal… [read post]
13 Jul 2007, 2:40 pm
Some Lessons Learned From A "Top 10" Drug Errors Session At The American Pharmacists Association 2007 Annual Meeting (Posted by Tom Lamb at DrugInjuryWatch.com) The American Pharmacists Association (APhA) Annual Meeting was held in Atlanta, Georgia earlier this year. [read post]
26 Feb 2009, 1:44 pm
Senator Grassley's Report On How Glaxo Defended Avandia In Wake Of 2007 NEJM Article By Nissen And Wolski Is Expected To Be Released Soon (Posted by Tom Lamb at DrugInjuryWatch.com) On May 21, 2007, in our post titled "Glaxo's Diabetes Drug Avandia May Cause Significant Heart Attack Risk", we reported about the Los Angeles Times publishing a May 21 article which broke the story about a new analysis of Avandia data  that had been published… [read post]