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18 Sep 2008, 9:17 pm
Abrahamsen Asserts Atypical Fractures Of Femur Are Not Triggered By Fosamax (Posted by Tom Lamb at In late June 2008 we learned that one type of femoral stress fracture (simple, transverse) may be caused by long term use of the popular bisphosphonate Fosamax. [read post]
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 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]
15 Apr 2009, 11:53 am
An Introduction Using Examples And Facts Relevant To Avoiding Drug-Drug Interaction Risks (Posted by Tom Lamb at Patients who require multiple prescription drugs at one time, i.e., concomitant use, are sometimes placed at risk for developing drug-drug interactions (DDIs), where one drug alters the effect of another drug. [read post]
14 Jul 2009, 12:52 pm
July 2009 Canadian Adverse Reaction Newsletter Provides Summary Of Reports Made To Health Canada (Posted by Tom Lamb at Singulair (montelukast) has been marketed in Canada since 1997. [read post]
3 Jun 2008, 10:47 am
New Canadian Study Highlights Link Between Some Medications And Serious Health Problems (Posted by Tom Lamb at A June 3, 2008 article, "More than 1 in 9 ER visits medication-related", in  The Globe and Mail reported the highlights of a study published in June 2008 by the Canadian Medical Association Journal which concerned 1,017 patients who presented at the Vancouver General Hospital emergency room (ER) during a 12-week period back in… [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 We learned in April 2010 from U.S. [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 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]
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 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 In the run up to the November 3, 2008 oral arguments in the Wyeth v. [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 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]
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 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]
11 Sep 2009, 10:33 am
., Parke-Davis, Warner-Lambert, and Pfizer (Posted by Tom Lamb at 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 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 On June 25, 2009 the FDA issued a press release, "U.S. [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 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 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 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]
10 Sep 2007, 10:14 am
2007 Medical Journal Article Reports That Ketek May Cause A Greater Than 80% Increased Risk Of Hepatotoxicity (Posted by Tom Lamb at In early September 2007 Health Canada issued a MedEffect alert about Ketek which was based upon their review of the available safety information, including reported cases of severe liver injury. [read post]
7 Oct 2010, 12:19 pm by Tom Lamb
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 In early October 2010 the New Jersey state court jury which heard the evidence in the case of Bessemer v. [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 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]
17 Feb 2012, 12:52 pm by Tom Lamb
Same General Warning About All COCs Was Added To YAZ In March 2011; And Why The One Year Delay, We Wonder (Posted by Tom Lamb at The February 14, 2012 email captioned "What's New on the FDA Drugs Site" let us know that there was a new version of the Package Insert for Yasmin, Safyral, and Beyaz which consisted of four new sentences being added to the WARNINGS AND PRECAUTIONS section: 5.1 Thromboembolic Disorders and Other Vascular Problems ... [read post]
20 Aug 2012, 11:15 am by Tom Lamb
This Pradaxa MDL Case Will Include Gastrointestinal Bleeding And Other Hemorrhages As Well As Heart Attacks Or Myocardial Infarctions (Posted by Tom Lamb at Pradaxa is a blood-thinning drug used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem.  [read post]