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4 Jan 2008, 8:33 am
Public Citizen Files Lawsuit Against FDA Seeking "Black Box" Warning About This Painful And Lingering Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) According to a January 3, 2008 Reuters article, "Group sues U.S. in push for new antibiotic warning", the consumer group Public Citizen has filed a lawsuit intended to force the FDA to consider whether stronger warnings should be added to certain antibiotics such as Johnson & Johnson's… [read post]
3 Nov 2008, 5:01 pm
Read What The Attorneys For Diana Levine And Wyeth Argued, And What Questions Were Asked By The Justices Regarding Possible Federal Preemption Of This Drug Injury Case (Posted by Tom Lamb at DrugInjuryWatch.com) In the run up to the November 3, 2008 oral arguments in the Wyeth v. [read post]
20 May 2008, 9:08 am
Actavis, Mylan, Or The FDA Should Tell Public Their Current Estimate Of How Many Defective Digitek Pills Were Distributed To Pharmacies, And During What Time Period (Posted by Tom Lamb at DrugInjuryWatch.com) On May 9, 2008 Actavis North America issued this press release "Digitek ® recall - customer support and frequently asked questions", which looked like it contained some new information about the Digitek recall. [read post]
21 Jan 2009, 7:10 am
ISMP QuarterWatch: Cannot "rule out, or state definitively, whether defective digoxin tablets led to hundreds of patient deaths" (Posted by Tom Lamb at DrugInjuryWatch.com) On January 15, 2009 The Institute for Safe Medication Practices (ISMP) released QuarterWatch: 2008 Quarter 2, which includes an analysis of how the Digitek recall has been handled by Actavis, the drug maker, and FDA, the regulatory agency, which demonstrates how ineffectual the FDA has become when it… [read post]
26 Jun 2009, 1:24 pm
Marshals Seize Drug Products From Caraco's Three Michigan Facilities Due To Continuing Lack Of Quality Controls (Posted by Tom Lamb at DrugInjuryWatch.com) On June 25, 2009 the FDA issued a press release, "U.S. [read post]
11 Sep 2009, 10:33 am
., Parke-Davis, Warner-Lambert, and Pfizer (Posted by Tom Lamb at DrugInjuryWatch.com) The Drug Industry Document Archive (DIDA), created by the University of California at  San Francisco (UCSF), contains over 1500 documents, many of which were previously secret and only made public as a result of lawsuits filed against pharmaceutical companies. [read post]
26 Aug 2008, 3:28 pm
Inspection Found Sandoz  Failed To Properly Validate Manufacturing Process For Metoprolol Succinate ER Tablets (Generic Form Of Toprol XL) Before Distributing Pills (Posted by Tom Lamb at DrugInjuryWatch.com) There is yet another apparent quality-control problem in the generic drug manufacturer sector. [read post]
24 Oct 2007, 2:01 pm
A "Dear Doctor" Letter About Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Associated With Provigil Was Sent In September 2007 (Posted by Tom Lamb at DrugInjuryWatch.com) On October 24, 2007 the FDA sent an email alert to inform doctors and other healthcare providers that the drug company Cephalon issued a revised package insert, or label, for Provigil (modafinil) in August 2007. [read post]
20 Sep 2007, 3:04 pm
FDA Links Cephalon's Provigil To Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, And Erythema Multiforme (Posted by Tom Lamb at DrugInjuryWatch.com) According to the Fall 2007 FDA Drug Safety Newsletter (Volume 1, Number 1), which was released in mid-September 2007, the FDA has been monitoring cases of serious skin reactions associated with the sleep disorder drug Provigil (modafinil). [read post]
16 May 2011, 1:03 pm by Tom Lamb
A Pulmonary Embolism Case Is Selected By Judge Herndon; More Than 6600 Lawsuits Filed Against Bayer As Of May 2011 (Posted by Tom Lamb at DrugInjuryWatch.com) In May 2011 federal court Judge David R. [read post]
22 Dec 2011, 2:52 pm by Tom Lamb
December 2011: Some Recent Medical Studies About These Bisphosphonate-Related Subtorchanteric Or Atypical Femoral Fractures (Posted by Tom Lamb at DrugInjuryWatch.com) Here are some recent reports about medical studies concerning the association, or link, between bisphosphonate drugs such as Fosamax and Boniva that are used to treat osteoporosis and the risk of a rare but serious type of thigh bone fracture known as an "atypical femur fracture. [read post]
10 Sep 2008, 9:32 pm
Recall That Bristol-Myers Had Said Decline In Sales Was Reason For Its Decision To Stop Selling Tequin (Posted by Tom Lamb at DrugInjuryWatch.com) On September 2, 2008 the FDA issued a Notice entitled "Determination That TEQUIN (Gatifloxacin) Was Withdrawn From Sale for Reasons of Safety or Effectiveness"  which provides (and confirms) the real reason that Bristol-Myers Squibb Co. [read post]
1 Jul 2009, 1:06 pm
Will Warn About Risk Of Serious Neuropsychiatric Symptoms Including Agitation, Depression, Suicidal Thoughts, And Attempted Suicide (Posted by Tom Lamb at DrugInjuryWatch.com) On July 1, 2009 the FDA issued a Public Health Advisory about Chantix (varenicline) as well as Wellbutrin (bupropion) and Zyban (bupropion) which announced that these smoking cessation drugs will be getting a so-called "black-box" warning: ...highlighting the risk of serious neuropsychiatric… [read post]
7 Aug 2007, 2:36 pm
Risk For Heart Attack And Death From Cardiovascular Disease For Diabetic Patients Using Avandia: "Uncertain" (Posted by Tom Lamb at DrugInjuryWatch.com) On August 6, 2007 the medical journal Annals of Internal Medicine published online an early-release version of a new Avandia article, "Uncertain Effects of Rosiglitazone on the Risk for Myocardial Infarction and Cardiovascular Death", that analyzes the recently reported Nissen and Wolski… [read post]
25 Aug 2011, 2:02 pm by Tom Lamb
Federal Court Judge Keenan Wants Two More Fosamax - ONJ Bellwether Cases To Go To Jury Verdict After This Trial(Posted by Tom Lamb at DrugInjuryWatch.com)______________________________________________________________________________ UPDATE:  "Merck Wins Another Federal Bellwether Trial Regarding FOSAMAX(R) (alendronate sodium)"  (10/3/11, Merck Press Release)_____________________________________________________________________ UPDATE:  On August 30, 2011… [read post]
6 Aug 2008, 1:40 pm
August 2008 ASA Meeting: Sociologist Donald Light Presents His Paper, "Institutional Foundations of the Vioxx Disaster" (Posted by Tom Lamb at DrugInjuryWatch.com) On August 3, 2008, at the American Sociological Association (ASA) annual meeting in Boston, Donald W. [read post]
8 May 2007, 8:30 am
Recent Subjects Have Been Drug Recalls Involving IBS Medication Zelnorm And Parkinson's Drug Permax (Posted by Tom Lamb at DrugInjuryWatch.com) An April 20, 2007 FDA News item reminded doctors and other health care professionals as well as patients and interested consumers that since February 2007 the FDA has been providing its emerging drug safety information by means of audio broadcasts. [read post]
1 Oct 2009, 12:47 pm
MDL No. 2100 -- IN RE: Yasmin and Yaz (Drospirenone) Marketing and Sales Practices and Products Liability Litigation -- Assigned To Southern District of Illinois (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE:  Our Focus Page on YAZ / Yasmin / Ocella  has a complete collection of our articles about these birth control pills as well as selected news reports about YAZ, Yasmin, and… [read post]
12 Aug 2008, 8:18 pm
August 2008 Senate Counterpart of HR 6381, Medical Device Safety Act 2008, Which Was Sponsored By Congressmen Waxman And Pallone (Posted by Tom Lamb at DrugInjuryWatch.com) In a June 27, 2008 article, "Newly Introduced Legislation Would Protect Legal Rights of Patients Harmed By Defective Medical Devices", we said that soon after the July 4th Congressional recess there would be a bill introduced by Senators Ted Kennedy (D-Mass.) and Patrick Leahy (D-Vt.) [read post]