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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]
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]
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]
1 Oct 2009, 12:47 pm
MDL No. 2100 -- IN RE: Yasmin and Yaz (Drospirenone) Marketing and Sales Practices and Products Liability Litigation -- Assigned To Southern District of Illinois (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: Our Focus Page on YAZ / Yasmin / Ocella has a complete collection of our articles about these birth control pills as well as selected news reports about YAZ, Yasmin, and… [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]
20 Sep 2007, 3:04 pm
FDA Links Cephalon's Provigil To Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, And Erythema Multiforme (Posted by Tom Lamb at DrugInjuryWatch.com) According to the Fall 2007 FDA Drug Safety Newsletter (Volume 1, Number 1), which was released in mid-September 2007, the FDA has been monitoring cases of serious skin reactions associated with the sleep disorder drug Provigil (modafinil). [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]
22 Apr 2007, 12:35 pm
FDA Staffers' Letter To Editor Defends Steps Taken Over Time As Regards This Controversial Sanofi-Aventis Antibiotic (Posted by Tom Lamb at DrugInjuryWatch.com) In the April 19, 2007 New England Journal of Medicine (NEJM) appears "The FDA and the Case of Ketek", by David B. [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]
1 Jul 2009, 1:06 pm
Will Warn About Risk Of Serious Neuropsychiatric Symptoms Including Agitation, Depression, Suicidal Thoughts, And Attempted Suicide (Posted by Tom Lamb at DrugInjuryWatch.com) On July 1, 2009 the FDA issued a Public Health Advisory about Chantix (varenicline) as well as Wellbutrin (bupropion) and Zyban (bupropion) which announced that these smoking cessation drugs will be getting a so-called "black-box" warning: ...highlighting the risk of serious neuropsychiatric… [read post]
28 Oct 2011, 6:16 pm
(Posted by Tom Lamb at DrugInjuryWatch.com) On October 27, 2011 the FDA released its new drug-safety study report, "Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints", which included the NuvaRing (etonogestrel / estradiol vaginal ring) -- referred to as "ETON" in this 2011 FDA study report. [read post]
21 Aug 2007, 8:26 am
This Second Edition Has Detailed, Useful Information For Doctors And Pharmacists (Posted by Tom Lamb at DrugInjuryWatch.com) The August 9, 2007 edition of The New England Journal of Medicine (NEJM) has an insightful book review by John P. [read post]
31 Aug 2009, 1:45 pm
Medical Journal Letter To Editor Stated That Exact Mechanism Of Hepatotoxicity In Subject Patient Was Unknown (Posted by Tom Lamb at DrugInjuryWatch.com) As we reported, on August 24, 2009 the FDA issued its "Early Communication" notification about an ongoing safety review of the obesity drugs Xenical (orlistat 120 mg) and Alli (orlistat 60 mg). [read post]
19 Oct 2007, 6:35 am
This Medtronic Defibrillator Lead Line Was Particularly Popular In Younger Patients Due To Its Smaller Size (Posted by Tom Lamb at DrugInjuryWatch.com) In an October 19, 2007 article, "Heart Wires May Pose More Risk for the Young", Wall Street Journal (WSJ) reporters Anna Wilde Mathews and Thomas M. [read post]
16 May 2007, 10:34 am
Plaintiff Simon Developed Breast Cancer After Using HRT Drugs Prempro, Premarin, And Provera (Posted by Tom Lamb at DrugInjuryWatch.com) On May 15, 2007 a Pennsylvania state court jury handed down a mixed verdict in the latest hormone replacement therapy (HRT) products liability case to go to trial, Simon v. [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]
18 Feb 2010, 12:52 pm
Reports About Sudden Breaking Of Thigh Bone In Patients Using Fosamax For Five Years Or More (Posted by Tom Lamb at DrugInjuryWatch.com) The side effects of Fosamax include osteonecrosis of the jaw (ONJ), esophageal irritation, and musculoskeletal pain. [read post]
11 Feb 2008, 9:20 am
February 2008 Australian Report Links Liver Failure And Hepatitis To Popular Novartis Drug (Posted by Tom Lamb at DrugInjuryWatch.com) A February 4, 2008 article, "Anti-fungal tablet linked to liver deaths", published by Australia's Herald Sun newspaper, brought to our attention the fact that Australian drug regulators have issued a warning about serious liver reactions after taking a popular prescription drug used to treat fungal infections, Lamisil… [read post]
16 Feb 2007, 7:40 am
Plaintiff Alleged Wyeth Used False And Misleading Advertising For Prempro And Premarin, Thereby Hiding Risks (Posted by Tom Lamb at DrugInjuryWatch.com) On February 15, 2007 a federal court jury in Arkansas found the drug company Wyeth not liable for the breast cancer which 72-year old Helene Rush alleged was caused by her use of Prempro and Premarin. [read post]
22 Sep 2011, 12:00 pm
EMA Cites The Increased Risks Of Liver Injury, Lung Side Effects, And Cardiovascular Adverse Events (Posted by Tom Lamb at DrugInjuryWatch.com) In late September 2011 the European Medicines Agency (EMA) recommended that the use of Sanofi's antiarrhythmic medication Multaq (dronedarone) be restricted to certain patients with paroxysmal or persistent atrial fibrillation. [read post]
