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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]
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]
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]
22 Oct 2012, 12:40 pm
Combination Pill Of Topamax And Phentremine Was Approved By FDA, But EMA Points To Heart Side Effects, Birth Defects, And Other Safety Issues (Posted by Tom Lamb at DrugInjuryWatch.com) On October 18, 2012 European drug regulators took a different course than the FDA with regard to a new anti-obesity medication which contains the active ingredient in Topamax, topiramate, and phentermine. [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]
13 Jul 2007, 2:40 pm
Some Lessons Learned From A "Top 10" Drug Errors Session At The American Pharmacists Association 2007 Annual Meeting (Posted by Tom Lamb at DrugInjuryWatch.com) The American Pharmacists Association (APhA) Annual Meeting was held in Atlanta, Georgia earlier this year. [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]
22 Jul 2011, 2:34 pm
FDA Now Looking At Two-Fold Increase In CV Deaths, Strokes, And Heart Failure Hospitalizations From PALLAS Study Data (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "Multaq (dronedarone) - Information on Increase in Heart-Related Events in Patients with Permanent Atrial Fibrillation - Sanofi-aventis Canada Inc. [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]
5 Jun 2012, 2:35 pm
Pradaxa Adverse Reactions And Serious Bleeding Events More Common In Older Patients And Females, With Reduced Renal Function Also Being A Factor (Posted by Tom Lamb at DrugInjuryWatch.com) In April 2012 the manufacturer of Pradaxa (dabigatran), Boehringer Ingelheim, announced it is launching the GLORIA TM-AF Registry Program, which is designed to gather real-world data on patient demographics, disease characteristics, treatment decisions, and the safety and efficacy of Pradaxa as… [read post]
6 Jul 2012, 1:02 pm
New Medical Journal Article Provides More Information About Emerging Drug Safety Issue Involving Avandia / Actos Side Effect Affecting Sight And Vision (Posted by Tom Lamb at DrugInjuryWatch.com) According to a recent medical journal article, "Association between thiazolidinedione treatment and risk of macular edema among patients with type 2 diabetes", published online in June 2012 by the Archives of Internal Medicine, the diabetes drugs Actos (pioglitazone) and… [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]
10 Dec 2008, 10:21 pm
Currently Print Drug Ads Are Required To Show Information So That Patients Can Report Serious Side Effects To FDA MedWatch Program (Posted by Tom Lamb at DrugInjuryWatch.com) A November 25, 2008 Associated Press (AP) article, "FDA to study phone number to report side effects", let us know about an issue that the FDA will be considering, soon: Whether television drug advertisements should urge… [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]
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]
4 Feb 2010, 12:39 pm
Medtronic Says 4.6 Percent Of Leads Failed, While Reports From Some Hospitals Indicate 9.2 Percent Of Sprint Fidelis Wires Failed (Posted by Tom Lamb at DrugInjuryWatch.com) In our December 30, 2009 article, "Sprint Fidelis Lead Wire Failure Rate Could Rise To 30 Percent By Four Years", we provided the little bit of information we could find, then, about the future failure rates for the Medtronic Sprint Fidelis lead wires that were removed from the market… [read post]
2 Sep 2009, 11:46 am
August 2009 Medical Journal Article Presents Well-Documented Report Of Pancreatitis In Context Of Byetta Use (Posted by Tom Lamb at DrugInjuryWatch.com) In October 2007 the FDA announced that the agency had reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta (exenatide), a drug used to treat adults with type 2 diabetes. [read post]
22 May 2009, 11:24 am
Agency Has Received Case Reports Of Hepatotoxicity For Orlistat, The Active Ingredient For Xenical And Alli (Posted by Tom Lamb at DrugInjuryWatch.com) There was only this brief mention in the Memorandum of Meeting Minutes for the FDA's April 16, 2009 Drug Safety Oversight Board Meeting: The Drug Safety Oversight Board (DSB) discussed two topics: the product orlistat and the potential risk of hepatotoxicity and alcohol-based skin antiseptics and the risk of a fire in the… [read post]
18 Mar 2009, 11:56 am
Risk Is Greatest For Elderly, Especially Older Women, And Long-Term Users Of This Popular Gastrointestinal Medication (Posted by Tom Lamb at DrugInjuryWatch.com) On February 26, 2009 the FDA sent by email a MedWatch Alert, "Metoclopramide-containing drugs: chronic use linked to tardive dyskinesia", which included this information: FDA notified healthcare professionals that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a… [read post]
19 Jun 2009, 12:29 pm
Doctors Should Inform Their Patients About Potential Serious Side Effects Like Osteonecrosis Of The Jaw And Femur Fractures (Posted by Tom Lamb at DrugInjuryWatch.com) The rather alerting headline above comes from an article, "Osteoporosis treatments and adverse events", which was published in the April 30, 2009 edition of Current Opinion in Rheumatology. [read post]
