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31 Aug 2012, 2:30 pm
Approved By FDA In 2010, There Has Been No Study Done Yet Regarding Beyaz Safety -- Despite Significant Number Of Beyaz Adverse Event Reports (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: FDA Meeting Materials for Pediatric Focused Safety Review: Beyaz (ethinyl estradiol, drospirenone, levomefolate calcium) Pediatric Advisory Committee Meeting September 11, 2012 (PowerPoint PDF) (9/19/12)… [read post]
28 Mar 2008, 7:42 am
A Couple Of Recent Offerings From Our Readers, For Your Consideration (Posted by Tom Lamb at DrugInjuryWatch.com) As you will see, we have two readers who emailed me recently to thank for today's post. [read post]
1 Feb 2008, 2:53 pm
Three Medical Journal Articles From Late 2007 Shed More Light On Risk Factors, Prevention, And Treatment Of These Serious Bone Diseases Associated With Fosamax And Similar Drugs (Posted by Tom Lamb at DrugInjuryWatch.com) We start our review of recent medical journal articles about bisphosphonate-induced osteonecrosis and osteomyelitis of the jaw with a November 2007 article, "Bisphosphonates and Bisphosphonate Induced Osteonecrosis", written by Yoh Sawatari and… [read post]
10 Nov 2010, 5:55 am
Patients Have No Legal Claim Due To Federal Preemption Ruling (Posted by Tom Lamb at DrugInjuryWatch.com) As those who have been following the Sprint Fidelis litigation know by now, the thousands of product liability lawsuits that had been filed in connection with the defective lead wire recall by Medtronic did not go the way that injured plaintiffs had hoped. [read post]
3 Oct 2012, 11:00 am
Newly Available Expert Analysis Of Confidential Drug Company Data Reveals That NuvaRing Estrogen Levels In Studies Were A Cause For Concern, And The Method Of Reporting Was Misleading (Posted by Tom Lamb at DrugInjuryWatch.com) In the pending NuvaRing litigation a federal judge recently unsealed some significant documents previously protected under claims of confidentiality. [read post]
6 May 2009, 3:01 pm
May 12 Hearing In Washington Begins The Debate About Whether The Medical Device Industry Should Have Total Immunity From Legal Liability (Posted by Tom Lamb at DrugInjuryWatch.com) On May 12, 2009 the Health Subcommittee of the House Energy and Commerce Committee will have a hearing on the Medical Device Safety Act of 2009. [read post]
24 May 2007, 3:47 pm
In Comparison, Europe's Regulators Had Glaxo Change Avandia Label In 2006 To Include Warning About Risk Of Cardiac Ischemic Events Such As Heart Attacks (Posted by Tom Lamb at DrugInjuryWatch.com) In a May 24, 2007 New York Times (NYT) article about Avandia, Stephanie Sauls and Gardiner Harris reported the FDA was put on notice as far back as 2000 that there was concern in parts of the medical community about the cardiovascular safety of Avandia, a diabetes drug from… [read post]
2 Nov 2010, 11:00 am
Merck Issues Its "No Liability" Press Release On First Day Of Trial; 1092 Fosamax Lawsuits Filed As Of June 2010 (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: Merck Not at Fault in Fosamax Trial, Jurors Say (New York Times, 11/19/10) ... [read post]
23 Feb 2010, 1:34 pm
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… [read post]
9 May 2012, 12:51 pm
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]
14 Jan 2011, 11:14 am
Steven Nissen To Express "concerns about the safety, efficacy and tolerability of dronedarone" (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Multaq "safety warning" issued by European drug regulator MHRA on January 21, 2011: "New information on possible risk of liver injury with dronedarone (Multaq)" Includes "Dear Doctor" letter sent by… [read post]
9 Oct 2008, 3:59 pm
After Earlier Class 1 Recall Of Digitek, All Acvtavis Drugs Manufactured At Its Little Falls, NJ Plant Were Recalled In August 2008 (Posted by Tom Lamb at DrugInjuryWatch.com) On October 8, 2008 Representatives John D. [read post]
2 Feb 2009, 9:51 am
ETHEX Recall Goes To Retail Pharmacy Level For Hydromorphone HCl Tablets And Metoprolol Succinate ER Tablets, Only; All Other ETHEX Generics Recalled To Wholesale Level (Posted by Tom Lamb at DrugInjuryWatch.com) In late December 2008 KV Pharmaceutical announced another drug recall involving its subsidiary ETHEX Corporation, which covered "a single production lot of Hydromorphone HCl 2 mg tablets (Lot 90219, Exp: 3/2010; NDC 58177-0620-04), a pain management drug, following… [read post]
24 Feb 2009, 1:18 pm
Physicians Must Consider The Pros And Cons Of Surgical Removal Before Heart Device Shocks Unnecessarily Or Fails To Work When Patient Needed Shock (Posted by Tom Lamb at DrugInjuryWatch.com) On February 23, 2009 the medical journal HeartRhythm made available online an article by Robert G. [read post]
2 May 2011, 1:12 pm
April 2011 Edition Of BMJ Breaks News And Provides Insight From One Who Saw An Increased Risk Of Pancreatitis (Posted by Tom Lamb at DrugInjuryWatch.com) According to a news item published April 11, 2011 by The British Medical Journal (BMJ), letters written by Merck and Novo Nordisk to Anil Rustgi, the editor-in-chief of Gastroenterology, resulted in that journal withdrawing an article which it had posted on its website about how Januvia (sitagliptin)… [read post]
Procrit, Epogen, And Aranesp: New "Black Box" Warnings Only First Part Of FDA's Safety Re-evaluation
12 Mar 2007, 10:10 am
Popular Anemia Drugs Have Increased Risk Of Death, Blood Clots, Strokes, And Heart Attacks, Especially In Context Of Off-label Prescribing And Use (Posted by Tom Lamb at DrugInjuryWatch.com) On March 9, 2007 the FDA announced that Amgen Inc. and Johnson & Johnson (J&J) would add strong new warnings to their anemia drugs Procrit, Epogen, and Aranesp after several recent studies showed a higher risk of death and life-threatening side effects in some patients. [read post]
10 Aug 2009, 11:43 am
Important Safety Information For Women Who Are Currently Using YAZ / Yasmin / Ocella, NuvaRing, Or Ortho Evra For Contraception Or Hormone Replacement Therapy (Posted by Tom Lamb at DrugInjuryWatch.com) For women who are using estrogen-progestin methods of birth control, here is some important information from WebMD's Birth Control Health Center about the symptoms of some serious, potentially fatal side effects: The following symptoms, called… [read post]
4 Sep 2008, 9:08 pm
2008 Medical Journal Articles Describe Two Cases; Authors Suggest Liver Testing At Start Of Therapy And When Titrating Dosage Is Necessary (Posted by Tom Lamb at DrugInjuryWatch.com) In December 2007 we told you about an article by New York Times (NYT) reporter Alex Berenson, "Data About Zetia Risks Was Not Fully Revealed", which revealed that Merck and Schering-Plough had conducted several studies of Zetia that raised the possibility that Zetia can cause… [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]
20 Nov 2007, 7:18 am
(Posted by Tom Lamb at DrugInjuryWatch.com) In mid-November 2007 the FDA sent an MedWatch Email Alert to inform the public about an emerging drug safety issue involving Maxipime (Cefepime), an injectable antibiotic that was approved by the FDA in 1996. [read post]
