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26 Nov 2007, 3:06 pm
November 2007 Advisory Panel Meeting To Consider Safety of These Glaxo Drugs As Well As Novartis' Foradil (Posted by Tom Lamb at DrugInjuryWatch.com) An October 24, 2007 FDA staff report about Serevent (SUBJECT: 1-year Post-Pediatric Exclusivity Postmarketing Adverse Event Review) concluded that this inhaled beta-2 agonist asthma drugs as well as Advair "may have an unfavorable risk-benefit ratio" for children's asthma. [read post]
5 Nov 2007, 9:29 am
Market Withdrawal Or Recall Of Trasylol Seems Possible As Bayer Waits For Final Data From Halted BART Study (Posted by Tom Lamb at DrugInjuryWatch.com) On November 5, 2007 the FDA announced and Health Canada announced that sales of Bayer AG' s anti-bleeding drug Trasylol (aprotinin) would be suspended temporarily in the U.S. and Canada while investigations continued about whether Trayslol is linked to a higher risk of death than competing heart surgery drugs. [read post]
25 Jul 2012, 1:55 pm
And Another Medical Journal Article Concludes Venous Thromboembolism (VTE) Risk Associated With NuvaRing Is As High As YAZ Or Yasmin And Ortho Evra (Posted by Tom Lamb at DrugInjuryWatch.com) In May 2012 I wrote this article, "Merck Funded Study Says There Is No Blood Clot Risk With NuvaRing, While BMJ Medical Journal Article Reports A 90% Increased Risk", which pointed out some recent conflicting findings as regards serious NuvaRing side effects involving blood clots,… [read post]
24 Feb 2012, 2:08 pm
The Flores Case And The Sessner Case Involve Incidents Of ONJ Jaw Injury, Not The Femur Fracture Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: During pretrial hearings Judge Higbee severed the Flores case from the Sessner case. [read post]
29 Jul 2011, 2:32 pm
EMA Orders New Warning About Risk Of Venous Thromboembolism, While FDA And Health Canada Begin Safety Review (Posted by Tom Lamb at DrugInjuryWatch.com) In recent months there has been a flurry of activity by drug safety regulators in North America as well as Europe concerning the progestin drospirenone and its apparent association with an increased risk of venous thromboembolism, e.g., pulmonary embolus, more commonly called pulmonary embolism, or pulmonary emboli (when… [read post]
21 Mar 2011, 2:04 pm
Provides New Warnings About Certain Side Effects As Regards ALL Birth Control Pills (Not Specific To YAZ) (Posted by Tom Lamb at DrugInjuryWatch.com) The bottom line is this: There is nothing specific about YAZ in the new warning language added to the YAZ label by Bayer in March 2011. [read post]
29 Jan 2008, 3:13 pm
Congress Wants To Know When Sanofi-Aventis And The FDA Learned About Fraud Involved With Ketek Study 3014 (Posted by Tom Lamb at DrugInjuryWatch.com) Soon after noon on January 29, 2008 Ed Silverman posted on his Pharmalot blog an article, "House Committee Will Subpoena FDA Over Ketek", which reported this breaking news about the Congressional investigation into Ketek, Sanofi-Aventis, and the FDA:At its hearing this morning, the House Energy and Commerce… [read post]
18 Aug 2009, 11:32 am
Recent Studies Find That New Progestin Drospirenone Has 1.7 Times Increased Risk Of Developing Blood Clots Compared To Levonorgestrel (Posted by Tom Lamb at DrugInjuryWatch.com) Let's start with an August 13, 2009 MedPage Today article, "Thrombosis Risk with OCs Depends on Progestogen", from which we get this concise summary of the issue from Nick Dunn, MD, of the University of Southampton: All of the more recent progestogens, possibly except norgestimate, now… [read post]
22 Dec 2008, 11:03 pm
Two December 2008 Medical Journal Articles Examine Prescription Drug Hepatotoxicity And Reports Of Liver Damage Associated With Ketek (Posted by Tom Lamb at DrugInjuryWatch.com) Antibiotics cause drug-induced liver injury (DILI) more often than other prescription drugs according to a recent medical journal article, "Causes, Clinical Features, and Outcomes From a Prospective Study of Drug-Induced Liver Injury in the United States", which appeared in the December 2008… [read post]
16 Sep 2010, 2:36 pm
FDA Considering Issue Due To September 2010 American Society of Bone And Mineral Research Report About Bisphosphonate Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: FDA Drug Safety Communication: Safety update for osteoporosis drugs, bisphosphonates, and atypical fractures Safety Announcement [10-13-2010] The U.S. [read post]
25 Jul 2012, 1:55 pm
And Another Medical Journal Article Concludes Venous Thromboembolism (VTE) Risk Associated With NuvaRing Is As High As YAZ Or Yasmin And Ortho Evra (Posted by Tom Lamb at DrugInjuryWatch.com) In May 2012 I wrote this article, "Merck Funded Study Says There Is No Blood Clot Risk With NuvaRing, While BMJ Medical Journal Article Reports A 90% Increased Risk", which pointed out some recent conflicting findings as regards serious NuvaRing side effects involving blood clots,… [read post]
23 Nov 2011, 1:13 pm
Analysis Of PALLAS Study Data Shows Two-Times Increased Risk Of Death, Stroke, And Heart Attack (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: FDA Drug Safety Communication: Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events Safety Announcement [12-19-2011] The U.S. [read post]
28 Jun 2012, 2:45 pm
Medical Journal Article Reports Pradaxa-Induced Rectal Bleeding And Hemostatic Disorder In Two Elderly Patients (Posted by Tom Lamb at DrugInjuryWatch.com) On May 31, 2012 the Institute for Safe Medication Practices (ISMP) released its 2011 Annual Report Issue (PDF) which included new data for the second half of 2011 found in the FDA Adverse Event Reporting System (AERS), which consists of serious drug side effects information taken from FDA MedWatch reports. [read post]
23 Feb 2011, 2:48 pm
Long-Term Bisphosphonate Use Linked To Subtrochanteric And Femoral Shaft Fractures, Also Called Femur Fractures (Posted by Tom Lamb at DrugInjuryWatch.com) An article published in the February 23, 2011 edition of the medical journal JAMA (Journal of the American Medical Association) reports on research finding that older women who used Fosamax, Boniva, Reclast, or other bisphosphonate drugs had a significant increased risk of suffering leg fractures involving their thigh… [read post]
18 Mar 2008, 2:27 pm
March 2008 Article In FDA's Drug Safety Newsletter Discusses Two Cases In Detail (Posted by Tom Lamb at DrugInjuryWatch.com) The quarterly issue of the FDA's online Drug Safety Newsletter [DSN] which was published on March 18, 2008 includes an article about a postmarket safety review of Byetta (Exenatide) that associates this diabetes drug with acute pancreatitis. [read post]
6 Apr 2009, 1:13 pm
Angell, Former NEJM Editor-In-Chief And Current Harvard Medical School Professor, Writes An April 2009 Editorial For The Boston Globe (Posted by Tom Lamb at DrugInjuryWatch.com) Marcia Angell was the first woman to serve as editor-in-chief of The New England Journal of Medicine (NEJM). [read post]
18 May 2007, 6:41 am
Vioxx Trials Scheduled In CA, AL, FL, NV, WV, TX, and IL State Courts As Well As Federal Court MDL (Posted by Tom Lamb at DrugInjuryWatch.com) According to Merck & Co., as of May 11, 2007 there are seven trial dates set in various state courts around the country and one trial date set in the federal court Multi-district Litigation (MDL). [read post]
24 Jan 2007, 2:18 pm
Plaintiff Alleges Taking Prempro For Almost Ten Years Caused Her Breast Cancer (Posted by Tom Lamb at DrugInjuryWatch.com) In the third hormone replacement therapy (HRT) case to get to trial, 71-year old Helene Rush alleges that her breast cancer diagnosed in 1999 is due to the fact that she took Prempro, Wyeth Pharmaceuticals Inc.'s estrogen-progestin hormone therapy medication, for nearly ten years. [read post]
31 May 2007, 6:11 am
Wyeth Lawsuit (Posted by Tom Lamb at DrugInjuryWatch.com) On May 31, 2007 Wyeth announced that the Philadelphia Court of Common Pleas, of the Pennsylvania state court system, had granted the pharmaceutical company's motion for post-trial relief, and entered a judgment notwithstanding the verdict in favor of Wyeth in the lawsuit Jennie Nelson v. [read post]
23 Oct 2007, 7:02 am
Committee on Oversight and Government Reform Wants To Know What The FDA Knew About Defibrillator Lead Wire Fractures And When They Knew It (Posted by Tom Lamb at DrugInjuryWatch.com) On October 22, 2007, as Chairman of the Committee on Oversight and Government Reform, Congressman Henry Waxman (29th District, CA) sent a letter to FDA Commissioner Andrew von Eschenbach about the recently recalled Medtronic Sprint Fidelis defibrillator lead wires. [read post]
