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23 Aug 2007, 7:16 am
Will Consider Data Suggesting Trasylol Can Cause Kidney Damage, Heart Failure, and Death (Posted by Tom Lamb at DrugInjuryWatch.com) An August 22, 2007 article, "FDA panel will review Trasylol safety", published in the The Boston Globe informed that the FDA will convene an advisory committee of drug safety experts on September 12, 2007 to discuss Bayer AG's blood-clotting drug Trasylol. [read post]
31 Mar 2009, 12:16 pm
Digitek Brand Of Generic Digoxin Tablets Had Been Recalled In April 2008 For Same Reason (Posted by Tom Lamb at DrugInjuryWatch.com) On March 31, 2009 the FDA announced another generic digoxin pill recall by posting this company press release on the agency's web site: "Caraco Pharmaceutical Laboratories, Ltd. [read post]
7 Oct 2008, 9:05 pm
Then This List Is For You (Posted by Tom Lamb at DrugInjuryWatch.com) Over at the Nursing Degree Guide web site, Joel West has an article, "Top 50 Pharmacist Blogs", which is seemingly intended to let people know where they can go on the web to read daily posts about various topics having to do with prescription drugs and medications. [read post]
15 Nov 2010, 2:12 pm
November 2010 FDA Approval Of Merck Action Raises Profile Of This Emerging Drug Safety Issue (Posted by Tom Lamb at DrugInjuryWatch.com) As we reported recently, the October 2010 issue of the Canadian Adverse Reaction Newsletter (CARN) included an article titled "Statins and interstitial lung disease". [read post]
27 Aug 2008, 2:20 pm
This Petition Is Sponsored By A Group Of Concerned Citizens Called "Americans for Drug and Device Accountability" (Posted by Tom Lamb at DrugInjuryWatch.com) In several earlier posts I have advocated that any application of the federal preemption doctrine to drug injury lawsuits would effectively eliminate a significant incentive for the drug company to ensure that its drug labels reflect accurate and up-to-date safety information, i.e., the possibility of… [read post]
23 Apr 2008, 6:14 am
Utah Woman Developed Inflammatory Bowel Disease After Using This Hoffman-LaRoche Drug (Posted by Tom Lamb at DrugInjuryWatch.com) A 24-year old woman from Utah was awarded more than $10 million in legal compensation by a New Jersey state court jury in a trial involving the allegation that Accutane (isotretinoin), a prescription acne medication, caused her inflammatory bowel disease (IBD). [read post]
15 Aug 2007, 2:41 pm
Researchers Find There Is No Such Risk, However, For Men Using This Atrial Fibrillation Heart Drug (Posted by Tom Lamb at DrugInjuryWatch.com) An August 14, 2007 article published by Reuters, "Heart drug may lead to pacemaker use in women", reports a rather peculiar finding concerning the Wyeth (WYE) heart drug Cordarone (amiodarone), used to treat atrial fibrillation, insofar that a serious side effect of this drug appears to affect only women and not men. [read post]
9 Dec 2009, 8:14 pm
Lieutenant-General Sir Graham Lamb, a man who does not mince words as can [...] [read post]
28 Sep 2011, 1:43 pm
Possibly Increased Risk Of Blood Clot-Related Side Effects Like PE And DVT Suggested By Postmarketing Studies (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ 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… [read post]
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 DrugInjuryWatch.com) 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]
30 Mar 2009, 1:35 pm
This Event In Support Of Proposed Medical Device Safety Act Is Organized By The "Campaign to Stop Corporate Immunity" Group (Posted by Tom Lamb at DrugInjuryWatch.com) The Campaign to Stop Corporate Immunity (CSCI) group has arranged for some patients injured by defective medical devices -- such as the recalled Medtronic Sprint Fidelis lead wires that were used in certain defibrillators -- to be in Washington, DC on Tuesday, March 31, 2009 for the purpose of… [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]
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]
30 May 2012, 1:37 pm
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 DrugInjuryWatch.com) 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]
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]
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]
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 DrugInjuryWatch.com) In mid-December 2006 an FDA advisory panel recommended that any future use of the antibiotic Ketek should be restricted. [read post]
9 Oct 2012, 2:37 pm
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 DrugInjuryWatch.com) 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]
29 Sep 2009, 10:06 am
(Posted by Tom Lamb at DrugInjuryWatch.com) 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]
26 Sep 2012, 10:20 am
Use Of Pradaxa After ACS Is Associated With Increased Rate Of Major Bleeding, And Concomitant Use Of Pradaxa With Multaq Is Contraindicated (Posted by Tom Lamb at DrugInjuryWatch.com) When Pradaxa (dabigatran) is used to prevent thrombotic events after an acute coronary syndrome (ACS), it is associated with increased rates of major bleeding that offsets any antithrombotic benefit, according to a September 24, 2012 (Online First) Archives of Internal Medicine article, "Use… [read post]
