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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 DrugInjuryWatch.com) 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]
5 Mar 2012, 1:05 pm
Prescriber Error, Impaired Renal Function, Patient Age, And Lack Of An Effective Reversal Agent Are Cited (Posted by Tom Lamb at DrugInjuryWatch.com) A Letter to The Editor, titled "Bleeding Risk with Dabigatran in the Frail Elderly" (subscription required), which appeared in the March 1, 2012 edition of the New England Journal of Medicine (NEJM) may help explain when and why there is a serious bleeding risk associated with Pradaxa (dabigatran). [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 DrugInjuryWatch.com) 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]
10 Mar 2009, 11:11 am
Agency Publishes Notice In March 9 Edition Of The Federal Register: Seeking Public Comment On Proposed Voluntary Survey (Posted by Tom Lamb at DrugInjuryWatch.com) In May 2008 the FDA published a white paper, "The Sentinel Initiative - A National Strategy for Monitoring Medical Product Safety", that served to introduce and explain this new agency effort intended to to improve the post-approval monitoring of prescription drugs and medical devices. [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 DrugInjuryWatch.com) 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]
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 DrugInjuryWatch.com) We start with the something "old", which only goes back in time a few months. [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]
16 Dec 2010, 12:20 pm
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]
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 Feb 2011, 12:41 pm
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]
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 DrugInjuryWatch.com) 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]
15 Apr 2009, 11:53 am
An Introduction Using Examples And Facts Relevant To Avoiding Drug-Drug Interaction Risks (Posted by Tom Lamb at DrugInjuryWatch.com) 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]
30 May 2007, 10:22 am
Jury Awards $2.6 Million For Inflammatory Bowel Disease Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) 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]
3 Jun 2008, 10:47 am
New Canadian Study Highlights Link Between Some Medications And Serious Health Problems (Posted by Tom Lamb at DrugInjuryWatch.com) 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]
19 Jul 2011, 1:32 pm
Liver Failure, Renal Impairment, And Cardiovascular Problems Cited As Potential Signals Of Risk Involving Multaq (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Health Canada announced on July 21, 2011 that it is reviewing the heart-related safety of Multaq. [read post]
18 Sep 2008, 9:17 pm
Abrahamsen Asserts Atypical Fractures Of Femur Are Not Triggered By Fosamax (Posted by Tom Lamb at DrugInjuryWatch.com) 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]
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]
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 DrugInjuryWatch.com) Singulair (montelukast) has been marketed in Canada since 1997. [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 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]
