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20 Mar 2020, 9:45 am
(Case review is done by attorney Tom Lamb) [read post]
25 Apr 2011, 1:08 pm
Just As It Did In 2010 Label Change, Bayer Contends New Medical Studies Are Less Reliable Than Other VTE Evidence (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone [May 31, 2011]... [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]
10 Apr 2012, 1:15 pm
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]
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]
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]
26 Sep 2011, 12:46 pm
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]
20 Jul 2012, 1:30 pm
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]
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]
13 Apr 2009, 9:58 am
Covers Bowel Cleansing Agents Visicol and OsmoPrep, As Well As Methadone Overdoses, Ethex Generic Drug Recall, And Medication Errors (Posted by Tom Lamb at DrugInjuryWatch.com) The FDA's Patient Safety News (PSN) is a series of monthly video news shows intended primarily for doctors and other health care professionals. [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]
12 Jul 2011, 2:13 pm
EMA And FDA Already Had Sanofi Issue A "Dear Doctor" Letter About Liver Failure In January 2011 (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: The FDA announced on July 21, 2011 that it is reviewing data from the PALLAS study which was stopped early after the data monitoring committee found a two-fold increase in death, as well as two-fold increases in stroke and hospitalization… [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]
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]
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 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]
29 Dec 2011, 11:02 am
Three More Lawsuits (Boles, Jellema, and Spano) Set For Trial, And A Special Master Appointed To Conduct Settlement Talks (Posted by Tom Lamb at DrugInjuryWatch.com) There are currently more than 900 Fosamax lawsuits pending against defendant Merck Sharp & Dohme Corp. [read post]
23 Mar 2009, 11:50 am
Newly Released FDA Report Indicates Medtronic Had First Reports Of Lead Wire Problems In Late 2004 (Posted by Tom Lamb at DrugInjuryWatch.com) A March 14, 2009 New York Times (NYT) article, "Medtronic Links Device for Heart to 13 Deaths", by reporter Barry Meier gave us the latest developments regarding the problems that gave rise to the October 2007 recall of Sprint Fidelis lead wires used in defibrillators. [read post]
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]
