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28 Feb 2012, 1:11 pm
Bayer 2011 Annual Report: Settlement Agreements: 70 Cases Settled As of Mid-February 2012; Negotiations Will Continue On Case-by-Case Basis (Posted by Tom Lamb at DrugInjuryWatch.com) From February 1, 2011 to February 1, 2012 the number of lawsuits in the U.S. served upon Bayer involving side effects allegedly from the use of Bayer’s oral contraceptive products Yasmin™ and/or YAZ™ or from the use of Ocella™ and/or Gianvi™ has increased from… [read post]
16 Sep 2009, 1:38 pm
August 2009 FDA Warning Letter Sent To Bayer Relates To Quality Control Problems Found In March 2009 At German Facility Where DRSP Was Made (Posted by Tom Lamb at DrugInjuryWatch.com) By means of a September 15, 2009 Associated Press (AP) news article, "FDA Warns Bayer Over German Manufacturing Plant", we first learned about a Warning Letter sent by the FDA back on August 5, 2009. [read post]
6 Sep 2012, 11:00 am
Brief History Of This ONJ / Jaw Lawsuit: First, Mistrial; Second, Jury Verdict For Plaintiff But Award Reduced By Judge (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: We have been informed that there will not be a third Boles trial after all because just prior to its start Merck and the attorney for Shirley Boles agreed to a stipulation of damages amount that will be reduced to a… [read post]
16 Jul 2009, 3:13 pm
July 2009 Liver Transplantation Article Reports The Findings And Accompanying Editorial Makes The Recommendations (Posted by Tom Lamb at DrugInjuryWatch.com) In its July 2009 edition the medical journal Liver Transplantation published an article that provides an overview of the current situation concerning drug-induced acute liver failure (DIALF) in the U.S. and an editorial that makes some recommendations about how we might improve that… [read post]
16 Jun 2008, 1:58 pm
Recall Now Covers 30 mg And 60 mg Tablets Made During June 2006 To May 2008 Period Due To The Potential For Oversized Tablets (Posted by Tom Lamb at DrugInjuryWatch.com) As we reported recently, on June 10, 2008 the FDA issued a MedWatch Email Alert, "Morphine Sulfate 60 mg Extended Release Tablets - Recall of a Single Lot Due to a Report of a Tablet With Twice the Appropriate Thickness". [read post]
7 Dec 2007, 12:08 pm
Agency's Follow-Up On Its August 2007 "Early Communication" About These Heartburn Drugs Is Late, But Just In Time For Christmas Dinner (Posted by Tom Lamb at DrugInjuryWatch.com) As reported previously, in early August 2007 the FDA and Health Canada raised concerns about possible serious cardiac events in patients using Nexium and Prilosec, made by AstraZeneca (AZN), which are used for the treatment of gastroesophageal reflux disease (GERD) and esophageal… [read post]
15 Oct 2012, 1:58 pm
People Who Suffer These Atypical Femoral Fractures Are Well Treated With This Surgical Procedure Using Rod-Like Nail, With Low Rate Of Complications (Posted by Tom Lamb at DrugInjuryWatch.com) According a recent article about a presentation -- Clinical and functional outcomes in patients who sustained bisphosphonate-associated complete femur fractures. [read post]
31 Jul 2009, 11:45 am
(Posted by Tom Lamb at DrugInjuryWatch.com) In October 2008 Public Citizen petitioned the FDA to ban the sale of the diabetes drug Avandia (rosiglitazone) in the U.S. because its risks, which include heart attack and heart failure in addition to liver toxicity, far outweigh its benefits and because much safer alternatives exist for treating Type 2 diabetes. [read post]
26 Feb 2009, 1:44 pm
Senator Grassley's Report On How Glaxo Defended Avandia In Wake Of 2007 NEJM Article By Nissen And Wolski Is Expected To Be Released Soon (Posted by Tom Lamb at DrugInjuryWatch.com) On May 21, 2007, in our post titled "Glaxo's Diabetes Drug Avandia May Cause Significant Heart Attack Risk", we reported about the Los Angeles Times publishing a May 21 article which broke the story about a new analysis of Avandia data that had been published… [read post]
5 Mar 2009, 10:22 am
March 2009 Drug Safety Update Newsletter (UK) Raises Emerging Safety Issue Of Kidney-Related Side Effects From Byetta Use (Posted by Tom Lamb at DrugInjuryWatch.com) We last reported on Byetta (exenatide) in August 2008, when the FDA issued a MedWatch email alert about six new cases of hemorrhagic pancreatitis and necrotizing pancreatitis that had been reported to FDA since an October 2007 "Dear Doctor" letter about Byetta and acute pancreatitis was sent to doctors in… [read post]
18 Feb 2008, 8:45 am
Delay By Bayer And FDA Until November 2007, When Trasylol Sales Were "Suspended", Caused 22,000 Excess Deaths Per CBS Report (Posted by Tom Lamb at DrugInjuryWatch.com) According to interviews broadcast by CBS Television's 60 Minutes program about Trasylol on February 17, 2008, an estimated 22,000 patient lives could have been saved if the FDA had acted quicker to recall Trasylol, Bayer AG's drug used to stem bleeding during open heart surgery. [read post]
7 Oct 2010, 12:19 pm
This October 2010 New Jersey Trial Result Is In Stark Contrast To $3.2 Million Verdict In 2009 Montana Zometa Case (Posted by Tom Lamb at DrugInjuryWatch.com) In early October 2010 the New Jersey state court jury which heard the evidence in the case of Bessemer v. [read post]
5 Jul 2011, 10:35 am
Canadian Medical Journal Article Suggests That The June 2011 Label Change By FDA And Pfizer Is Not Sufficient Measure (Posted by Tom Lamb at DrugInjuryWatch.com) As some may recall, in mid-June 2011 the FDA issued these two items: Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events; and, FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular… [read post]
7 Dec 2011, 5:16 am
J&J Birth Control Patch Ortho Evra Safety Review Will Focus On Blood Clot Side Effects Like Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT) (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Transcript for the December 9, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee (PDF - 685KB) … [read post]
6 Sep 2012, 11:00 am
Brief History Of This ONJ / Jaw Lawsuit: First, Mistrial; Second, Jury Verdict For Plaintiff But Award Reduced By Judge (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-September 2012 there will be another trial in the federal court Fosamax MDL for osteonecrosis of the jaw (ONJ) / jaw injury cases, but this lawsuit is far from being a "new" matter in that drug injury litigation. [read post]
12 Sep 2012, 1:45 pm
Heart Drug Multaq Can Cause Pulmonary Fibrosis And Pneumonitis; Symptoms Are Inflammation Of The Lungs, Including Scarring And Thickening (Posted by Tom Lamb at DrugInjuryWatch.com) Multaq (dronedarone) is a drug used to treat abnormal heart rhythm (atrial fibrillation or atrial flutter). [read post]
19 Aug 2011, 1:55 pm
New Sanofi "Dear Doctor" Letter: Label Change Regarding Heart-Related Side Effects Coming Soon (Posted by Tom Lamb at DrugInjuryWatch.com)This August 2011 update on Multaq (dronedarone) covers both liver injury and cardiovascular side effects. [read post]
29 May 2008, 7:43 am
Confusion Between Similar Drugs Is A Cause Of Medication Errors That Agency Will Focus On In New Pilot Program (Posted by Tom Lamb at DrugInjuryWatch.com) To start, we get this background information from "Medication Errors: FDA 101", which was posted March 14, 2008 on the FDA's web site: A medication error is any preventable event that may cause or lead to inappropriate medication use or harm to a patient. [read post]
13 Jan 2011, 1:55 pm
2011 Raptiva Lawsuit Filed In Texas Against Drug Company: Failure To Warn About Side Effect Risks (Posted by Tom Lamb at DrugInjuryWatch.com)Back in 2009 we told you about some of the developments which led to Raptiva being withdrawn from the market in these two articles: -- A Timeline For The Psoriasis Drug Raptiva, From Product Launch In U.S. [read post]
27 Jan 2009, 3:00 pm
(Posted by Tom Lamb at DrugInjuryWatch.com) In the most recent FDA Drug Safety Newsletter (Volume 2, Number 1, 2009) we found a report, "Atomoxetine (Marketed as Strattera): Serious Liver Injury", that is rather disturbing insofar that the majority of patients at risk are children. [read post]
