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9 Oct 2012, 2:37 pm by Tom Lamb
Concomitant Use Of Tekturna With ACE Inhibitors And ARBs Contraindicated In Patients With Diabetes; Plus An FDA Caution Regarding Renal Impairment (Posted by Tom Lamb at Tekturna (aliskiren) was approved by the FDA for marketing in March 2007 after it was evaluated for safety in 6,460 patients, and only 1250 patients were treated for longer than 1 year.  [read post]
15 Jan 2007, 9:24 am
One Injury (Humeston) And One Death (Hermans) Case Involving Heart Attacks After Vioxx Use Will Go Before Jury (Posted by Tom Lamb at In a January 13, 2007 Bloomberg article by David Voreacos we learned that Judge Carol Higbee has cut the Carver and Kieley cases from the consolidated Vioxx trial that is starting later this month. [read post]
12 Feb 2007, 11:12 am
New Package Insert, Or Label, For Ketek Will Get Black-box Warning And Medication Guide For Patients, Also (Posted by Tom Lamb at In mid-December 2006 an FDA advisory panel recommended that any future use of the antibiotic Ketek should be restricted. [read post]
29 Sep 2009, 10:06 am
(Posted by Tom Lamb at On September 25, 2009 the FDA posted on its web site "Information for Healthcare Professionals - Acute pancreatitis and sitagliptin (marketed as Januvia and Janumet)". [read post]
8 Sep 2009, 12:20 pm
Healthcare Providers And Patients Are Encouraged To Report Adverse Events Involving Approved Or Unapproved Indications As Well As Medication Errors (Posted by Tom Lamb at In October 2006 Quintiles Inc., a leading CRO company, conducted a survey titled "Consumer Perceptions on Drug Safety" that consisted of 1726 US men and women aged 18 years and over. [read post]
30 Jul 2007, 12:11 am
Read Selected Essays From 77 Diverse Legal Blogs (aka Blawgs) In This Free eBook From TechnoLawyer (Posted by Tom Lamb at On July 30, 2007 TechnoLawyer issued a press release announcing the launch of BlawgWorld 2007, a free eBook that features a diverse and impressive collection of essays from the so-called legal blogosphere. [read post]
30 May 2012, 1:37 pm by Tom Lamb
Researchers Find Increased Number Of Low-Energy Subtrochanteric Fractures For A Period Ten Years After Introduction Of Fosamax In That Country (Posted by Tom Lamb at At the Orthopaedic Proceedings section of the Journal of Bone & Joint Surgery, British Volume, web site there is an item that presents some findings from a recent Australian study which supports the apparent link between Fosamax and atypical femur fractures. [read post]
28 Sep 2011, 1:43 pm by Tom Lamb
Possibly Increased Risk Of Blood Clot-Related Side Effects Like PE And DVT Suggested By Postmarketing Studies (Posted by Tom Lamb at _____________________________________________________________________ UPDATE:  Ortho Evra Update: October 2011 FDA Study Finds Increased Risk Of Serious Blood Clot Side Effects Like Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT) (11/2/11) _____________________________________________________________________ On December 9,… [read post]
18 Jul 2008, 6:03 pm
Something Old And Something New: Two Items From July 3, 2008 NEJM Show Why Preemption Applied In These Types Of Cases Is Bad Public Policy (Posted by Tom Lamb at We start with the something "old", which only goes back in time a few months. [read post]
28 Jan 2009, 5:30 am
Thought leaders like Ron Baker, Pat Lamb, Tom Kane and now law firm leaders won't let the topic go way. [read post]
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]
30 May 2007, 10:22 am
Jury Awards $2.6 Million For Inflammatory Bowel Disease Side Effect (Posted by Tom Lamb at On May 29, 2007 a New Jersey state court jury handed down a $2.619 million verdict against pharmaceutical company Hoffman-La Roche Inc. for the failure to warn that its acne drug Accutane can cause inflammatory bowel disease (IBD), as alleged in the Complaint for the lawsuit Andrew McCarrell v. [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]
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]
4 Jun 2008, 8:32 pm
FDA Will Conduct A Safety Review Of These TNF Blockers To Investigate This Possible Link (Posted by Tom Lamb at On June 4, 2008 the FDA issued an "Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers"announcing that the agency has started an investigation into the potential link between certain TNF blockers used to treat Juvenile Idiopathic Arthritis (JIA), Crohn's disease, or other diseases and the… [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]
30 Apr 2008, 2:18 pm
So-called "Digitalis Toxicity" Is Possible, Especially In Patients With Renal Failure (Posted by Tom Lamb at 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 We learned in April 2010 from U.S. [read post]
19 Jul 2011, 1:32 pm by Tom Lamb
Liver Failure, Renal Impairment, And Cardiovascular Problems Cited As Potential Signals Of Risk Involving Multaq (Posted by Tom Lamb at ______________________________________________________________________________ UPDATE:  Health Canada announced on July 21, 2011 that it is reviewing the heart-related safety of Multaq.  [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 The September 1, 2007 edition of Pharmaceutical Executive starts with the piece "From the Editor: What Do You Say? [read post]