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29 Feb 2008, 2:35 pm
Prescription Drugs Wrongly Prescribed Or Improperly Dispensed Are Preventable Adverse Events Which Need To Be Reduced In Number -- And This Can Be Done (Posted by Tom Lamb at DrugInjuryWatch.com) In a February 14, 2008 article, "1 in 10 patients gets drug error", Boston Globe reporter Patricia Wen presented some disturbing data from a study which examined adverse events involving prescription errors that occurred in six undisclosed Massachusetts community… [read post]
25 Jul 2012, 1:55 pm by Tom Lamb
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]
29 Aug 2007, 9:01 pm
Does Organon's Current NuvaRing Label Have Sufficient Warnings About Risk Of Blood Clots And Related Conditions (Posted by Tom Lamb at DrugInjuryWatch.com) In Part One of this series about NuvaRing we looked at some medical information about the so-called "third generation" progestin desogestrel causing a significant increased risk of venous thromboembolism, or serious blood clots; in turn, these blood clots can develop into a pulmonary embolism (PE), deep… [read post]
29 Jul 2011, 2:32 pm by Tom Lamb
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]
25 Jul 2012, 1:55 pm by Tom Lamb
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]
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]
26 Sep 2011, 12:46 pm by Tom Lamb
Early Results Suggest An Approximately 1.5-fold Increase In The Risk For Birth Control Pills With Drospirenone (DRSP) (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE:  YAZ / Yasmin / Ocella Update: October 2011 FDA Study Finds Increased Risk Of Blood Clot Side Effects Like DVT, PE, Stroke, And Heart Attack (11/2/11) _____________________________________________________________________ UPDATE:  New… [read post]
28 Jun 2012, 2:45 pm by Tom Lamb
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]
2 Jan 2008, 9:12 am
Sanofi-Aventis Antibiotic Has Been Subject Of Controversy Since Reports of Liver Damage Surfaced In Early 2006 (Posted by Tom Lamb at DrugInjuryWatch.com) The safety concerns about Ketek (telithromycin) began in early 2006 after Health Canada and the European Union's European Medicines Agency (EMEA) issued alerts based on the online "early" release of an article about Ketek that would later be published in the March 21, 2006 edition of the Annals of… [read post]
24 Feb 2012, 2:08 pm by Tom Lamb
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]
1 Sep 2011, 2:55 pm by Tom Lamb
Generic Drug Companies Should Have To Update Side Effect Warnings Or Face Drug Injury Lawsuits (Posted by Tom Lamb at DrugInjuryWatch.com) On August 29, 2011 the consumer advocacy group Public Citizen took action in an attempt to (1) require generic drug companies to warn about serious side effects caused by their prescription medications, and (2) to gain back for patients harmed by a generic medicine the right to file a drug injury lawsuit. [read post]
14 Aug 2012, 12:35 pm by Tom Lamb
August 2012 CMAJ Medical Journal Article Adds To Hepatotoxicity Evidence Against These Two Fluoroquinolone Drugs (Posted by Tom Lamb at DrugInjuryWatch.com) According to a case-control study published by the Canadian Medical Association Journal (CMAJ) on August 13, 2012, "Fluoroquinolone therapy and idiosyncratic acute liver injury: A population-based study"(full text), the use of two common antibiotics, Avelox (moxifloxacin) and Levaquin (levofloxacin), among older… [read post]
21 Mar 2011, 2:04 pm by Tom Lamb
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]
10 Apr 2012, 1:15 pm by Tom Lamb
Beyaz, Safyral, Ocella, Gianvi, Zarah, Loryna, Syeda, And Vestura OC Pills Contain DRSP Progestin Also (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE:  Bayer's "Dear Doctor" Letter about April 2012 label change (PDF) for its drospirenone (DRSP) birth control pills -- YAZ, Yasmin, Beyaz, and Safyral -- resulting from the December 8, 2011 FDA Advisory Committees meeting.… [read post]
20 Jul 2012, 1:30 pm by Tom Lamb
Once The FDA Started Paying Attention The Writing On The Wall Became Apparent, Albeit Too Late For Some (Posted by Tom Lamb at DrugInjuryWatch.com) This lengthy and well-presented news report, "Anemia drugs made billions, but at what cost? [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]
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]
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]
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]