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12 Oct 2009, 2:07 pm
Is Pancreatitis A Januvia Side Effect Or Is There An Increased Risk Of This Medical Condition Among Type 2 Diabetics Across All Treatments (Posted by Tom Lamb at A few weeks back we reported that the FDA wants Merck to change the package insert, or label, for the diabetes drug Januvia (sitagliptin)  so as to show an increased warning about the risk of developing pancreatitis. [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]
24 Aug 2009, 1:30 pm
FDA Early Communication Makes Clear That No Definite Association Between Liver Injury And Orlistat Has Been Established At This Time (Posted by Tom Lamb at On May 22, 2009 we first reported that the FDA is investigating the obesity drugs Xenical and Alli for a possible link with liver damage. [read post]
15 Feb 2008, 2:30 pm
Action Reportedly Intended To Emphasize 2007 Label Change About Severe, Possibly Fatal Liver And Skin Side Effects (Posted by Tom Lamb at A February 14, 2008 Reuters article, "Bayer warns doctors on rare Avelox side effects", reports that this German drug company is sending warning letters to doctors in Europe about the antibiotic Avelox, one of its top-selling drugs. [read post]
26 Mar 2007, 2:53 pm
The Letter Concerns Black-Box Warning, Prescribing Changes, And Patient Medication Guide Announced Back In Mid-February 2007 (Posted by Tom Lamb at On March 26, 2007 the FDA announced that a so-called "Dear Doctor" letter regarding the antibiotic Ketek (telithromycin) has been sent by Sanofi-Aventis to healthcare professionals alerting them to new safety information for Ketek. [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]
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]
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]
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]
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]
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]
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 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]
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]
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]
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]
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 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]
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]
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 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]