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16 Feb 2011, 12:41 pm by Tom Lamb
The Number Of Birth Control Lawsuits Filed Against Bayer Now Exceeds 6000 (Posted by Tom Lamb at DrugInjuryWatch.com) The number of YAZ, Yasmin, and Ocella lawsuits filed on behalf of women who have developed a blood clot-related side effect, such as pulmonary embolism (PE) or deep vein thrombosis (DVT), as well as those who have had to undergo gallbladder removal surgery now exceeds 6000. [read post]
30 Apr 2008, 2:18 pm
So-called "Digitalis Toxicity" Is Possible, Especially In Patients With Renal Failure (Posted by Tom Lamb at DrugInjuryWatch.com) In an April 28, 2008 MedWatch Safety Alert about Digitek (digoxin tablets), the FDA informed doctors and patients that this prescription medication is the subject of a nationwide Class I recall because of the possibility that some tablets were manufactured such that they contain twice the approved level of active ingredient. [read post]
16 Dec 2010, 12:20 pm by Tom Lamb
Discovery Deadlines And Expert Witness Deposition Dates Are Extended To Allow Time For Additional Document Review (Posted by Tom Lamb at DrugInjuryWatch.com) We learned in April 2010 from U.S. [read post]
15 Oct 2007, 2:25 pm
Two Perspectives On How Emerging Drug Safety Situations Should Be Handled Going Forward (Posted by Tom Lamb at DrugInjuryWatch.com) The September 1, 2007 edition of Pharmaceutical Executive starts with the piece "From the Editor: What Do You Say? [read post]
18 Sep 2007, 6:54 am
The Safety Profile Of Adderall, Concerta, Ritalin, Dexedrine And All Other ADHD / ADD Drugs Will Be Reviewed (Posted by Tom Lamb at DrugInjuryWatch.com) In a September 17, 2007 FDA News article titled "AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks With ADHD Medications" we learned that the safety of Adderall, Concerta, Ritalin, and Dexedrine -- as well as all other attention deficit hyperactivity disorder (ADHD) and attention deficit… [read post]
25 Oct 2010, 11:10 am by Tom Lamb
Novartis Sends "Dear Doctor" Letter To Canadian Physicians With Health Canada Endorsed Safety Information (Posted by Tom Lamb at DrugInjuryWatch.com) In 2007 Aclasta (zoledronic acid 5mg) was approved by the FDA under the brand name Aclasta® Injection as the first and only once-yearly medicine for postmenopausal osteoporosis.  [read post]
4 May 2012, 2:02 pm by Tom Lamb
A Drug Safety Controversy Continues: Whether It Is The Diabetes Drug Or The Diabetes Which Causes Pancreas Disease (Posted by Tom Lamb at DrugInjuryWatch.com) As regards the possible association between Victoza and pancreatitis as a side effect of this diabetes drug from Novo Nordisk, there have quite a few assorted developments during the period April 2011 to April 2012. [read post]
15 Nov 2012, 2:00 pm by Tom Lamb
The Relatively New Diabetes Medication Victoza From Novo Nordisk Was Only Approved By FDA In 2010 (Posted by Tom Lamb at DrugInjuryWatch.com) In November 2012 The Annals of Pharmacotherapy published online before print this new medical journal article about Victoza, "Pancreatitis: A Potential Complication of Liraglutide?". [read post]
23 Jun 2009, 10:46 am
This Public Interest Group Reviewed Gardasil Cases Found In FDA's Vaccine Adverse Event Reporting System (VAERS) (Posted by Tom Lamb at DrugInjuryWatch.com) According to the Gardasil web site: GARDASIL is the only cervical cancer vaccine that helps protect against 4 types of human papillomavirus (HPV): 2 types that cause 70% of cervical cancer cases, and 2 more types that cause 90% of genital warts cases. [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]
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 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]
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]
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]
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]
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]
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]
4 Aug 2009, 10:02 am
In July 2009 FDA Issues  Updated Guidance For Industry Document Concerning DILI In Premarketing Clinical Evaluation (Posted by Tom Lamb at DrugInjuryWatch.com) In July 2009 the FDA issued a Guidance  for Industry document intended for pharmaceutical companies developing new prescription drugs which  explains how certain laboratory measurements obtained in clinical trials can be used to assess the new drug's potential to cause severe… [read post]
10 Feb 2012, 10:38 am by Tom Lamb
At Increased Risk Are Patients Who Are Older, Have Altered Renal Clearance, Or Undergoing Atrial Fibrillation (AF) Ablation (Posted by Tom Lamb at DrugInjuryWatch.com) We first reported about Pradaxa (dabigatran) back in October 2011 in this article "New Heart Drug Pradaxa May Be Sending "Early" Drug Safety Signals". [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]