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24 Oct 2007, 2:01 pm
A "Dear Doctor" Letter About Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Associated With Provigil Was Sent In September 2007 (Posted by Tom Lamb at DrugInjuryWatch.com) On October 24, 2007 the FDA sent an email alert to inform doctors and other healthcare providers that the drug company Cephalon issued a revised package insert, or label, for Provigil (modafinil) in August 2007. [read post]
26 Jun 2009, 1:24 pm
Marshals Seize Drug Products From Caraco's Three Michigan Facilities Due To Continuing Lack Of Quality Controls (Posted by Tom Lamb at DrugInjuryWatch.com) On June 25, 2009 the FDA issued a press release, "U.S. [read post]
3 Nov 2008, 5:01 pm
Read What The Attorneys For Diana Levine And Wyeth Argued, And What Questions Were Asked By The Justices Regarding Possible Federal Preemption Of This Drug Injury Case (Posted by Tom Lamb at DrugInjuryWatch.com) In the run up to the November 3, 2008 oral arguments in the Wyeth v. [read post]
26 Aug 2008, 3:28 pm
Inspection Found Sandoz Failed To Properly Validate Manufacturing Process For Metoprolol Succinate ER Tablets (Generic Form Of Toprol XL) Before Distributing Pills (Posted by Tom Lamb at DrugInjuryWatch.com) There is yet another apparent quality-control problem in the generic drug manufacturer sector. [read post]
21 Jan 2009, 7:10 am
ISMP QuarterWatch: Cannot "rule out, or state definitively, whether defective digoxin tablets led to hundreds of patient deaths" (Posted by Tom Lamb at DrugInjuryWatch.com) On January 15, 2009 The Institute for Safe Medication Practices (ISMP) released QuarterWatch: 2008 Quarter 2, which includes an analysis of how the Digitek recall has been handled by Actavis, the drug maker, and FDA, the regulatory agency, which demonstrates how ineffectual the FDA has become when it… [read post]
4 Jan 2008, 8:33 am
Public Citizen Files Lawsuit Against FDA Seeking "Black Box" Warning About This Painful And Lingering Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) According to a January 3, 2008 Reuters article, "Group sues U.S. in push for new antibiotic warning", the consumer group Public Citizen has filed a lawsuit intended to force the FDA to consider whether stronger warnings should be added to certain antibiotics such as Johnson & Johnson's… [read post]
20 May 2008, 9:08 am
Actavis, Mylan, Or The FDA Should Tell Public Their Current Estimate Of How Many Defective Digitek Pills Were Distributed To Pharmacies, And During What Time Period (Posted by Tom Lamb at DrugInjuryWatch.com) On May 9, 2008 Actavis North America issued this press release "Digitek ® recall - customer support and frequently asked questions", which looked like it contained some new information about the Digitek recall. [read post]
11 Sep 2009, 10:33 am
., Parke-Davis, Warner-Lambert, and Pfizer (Posted by Tom Lamb at DrugInjuryWatch.com) The Drug Industry Document Archive (DIDA), created by the University of California at San Francisco (UCSF), contains over 1500 documents, many of which were previously secret and only made public as a result of lawsuits filed against pharmaceutical companies. [read post]
4 Aug 2009, 10:02 am
In July 2009 FDA Issues Updated Guidance For Industry Document Concerning DILI In Premarketing Clinical Evaluation (Posted by Tom Lamb at DrugInjuryWatch.com) In July 2009 the FDA issued a Guidance for Industry document intended for pharmaceutical companies developing new prescription drugs which explains how certain laboratory measurements obtained in clinical trials can be used to assess the new drug's potential to cause severe… [read post]
25 Sep 2007, 3:00 pm
FDA Post-Marketing Safety Review Adds Liver Problems To Previous Reports Of Kidney Failure Associated With Exjade (Posted by Tom Lamb at DrugInjuryWatch.com) In the first edition of FDA Drug Safety Newsletter (Volume 1, Number 1), which was posted on the FDA's web site September 18, 2007, there is an article about the agency's post-marketing safety review of Exjade (deferasirox). [read post]
10 Sep 2007, 10:14 am
2007 Medical Journal Article Reports That Ketek May Cause A Greater Than 80% Increased Risk Of Hepatotoxicity (Posted by Tom Lamb at DrugInjuryWatch.com) In early September 2007 Health Canada issued a MedEffect alert about Ketek which was based upon their review of the available safety information, including reported cases of severe liver injury. [read post]
13 Jul 2012, 2:17 pm
Greater Risk For Uveitis, Scleritis, And Other Ocular Side Effects According To Two Recent Medical Journal Articles (Posted by Tom Lamb at DrugInjuryWatch.com) Fosamax, Boniva, and other osteoporosis medications in the bisphosphonates drug class have been linked to osteonecrosis of the jaw (ONJ) and atypical femur fractures, with both of these side effects getting considerable coverage in the popular press for some years now. [read post]
6 Aug 2008, 1:40 pm
August 2008 ASA Meeting: Sociologist Donald Light Presents His Paper, "Institutional Foundations of the Vioxx Disaster" (Posted by Tom Lamb at DrugInjuryWatch.com) On August 3, 2008, at the American Sociological Association (ASA) annual meeting in Boston, Donald W. [read post]
16 Mar 2009, 11:20 am
Nonetheless, Pending Byetta Label Change Will Probably Add Stronger Warnings About Severe Pancreatitis Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) As some may recall, in August 2008 the FDA issued a MedWatch alert about six cases of hemorrhagic pancreatitis and necrotizing pancreatitis associated with the diabetes medicine Byetta. [read post]
7 Aug 2007, 2:36 pm
Risk For Heart Attack And Death From Cardiovascular Disease For Diabetic Patients Using Avandia: "Uncertain" (Posted by Tom Lamb at DrugInjuryWatch.com) On August 6, 2007 the medical journal Annals of Internal Medicine published online an early-release version of a new Avandia article, "Uncertain Effects of Rosiglitazone on the Risk for Myocardial Infarction and Cardiovascular Death", that analyzes the recently reported Nissen and Wolski… [read post]
10 Sep 2008, 9:32 pm
Recall That Bristol-Myers Had Said Decline In Sales Was Reason For Its Decision To Stop Selling Tequin (Posted by Tom Lamb at DrugInjuryWatch.com) On September 2, 2008 the FDA issued a Notice entitled "Determination That TEQUIN (Gatifloxacin) Was Withdrawn From Sale for Reasons of Safety or Effectiveness" which provides (and confirms) the real reason that Bristol-Myers Squibb Co. [read post]
25 Aug 2011, 2:02 pm
Federal Court Judge Keenan Wants Two More Fosamax - ONJ Bellwether Cases To Go To Jury Verdict After This Trial(Posted by Tom Lamb at DrugInjuryWatch.com)______________________________________________________________________________ UPDATE: "Merck Wins Another Federal Bellwether Trial Regarding FOSAMAX(R) (alendronate sodium)" (10/3/11, Merck Press Release)_____________________________________________________________________ UPDATE: On August 30, 2011… [read post]
4 Jul 2009, 8:14 am
New Medical Journal Article Follows June 2009 FDA-Required Warning For Singulair About Neuropsychiatric Events (Posted by Tom Lamb at DrugInjuryWatch.com) On June 12, 2009 the FDA announced a new warning about an increased risk of neuropsychiatric events for the asthma medicine Singulair (montelukast)-- as well as some other less popular leukotriene inhibitors, Accolate (zafirlukast) as well as Zyflo and Zyflo CR (zileuton). [read post]
30 Apr 2012, 1:49 pm
While Mediations And Negotiations Continue, The First Scheduled YAZ / Yasmin Trials In Federal And State Courts Are Postponed Indefinitely (Posted by Tom Lamb at DrugInjuryWatch.com) In late April 2012 Bayer announced that it has settled lawsuits involving YAZ and Yasmin side effects related to blood clots, namely deep vein thrombosis (DVT) and pulmonary embolism (PE) cases. [read post]
24 Jan 2011, 12:04 pm
Merck Case Involves Woman Who Alleges She Developed Osteonecrosis Of The Jaw (ONJ) (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: "Merck Wins First Fosamax ‘Jaw Death’ State-Court Trial" (2/14/2011, Bloomberg Businessweek) _____________________________________________________________________ On January 18, 2011 the first Fosamax trial involving bisphosphonate-related… [read post]
