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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]
26 Sep 2012, 10:20 am by Tom Lamb
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 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 of… [read post]
22 Dec 2011, 2:52 pm by Tom Lamb
December 2011: Some Recent Medical Studies About These Bisphosphonate-Related Subtorchanteric Or Atypical Femoral Fractures (Posted by Tom Lamb at Here are some recent reports about medical studies concerning the association, or link, between bisphosphonate drugs such as Fosamax and Boniva that are used to treat osteoporosis and the risk of a rare but serious type of thigh bone fracture known as an "atypical femur fracture [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]
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 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]
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]
8 Mar 2012, 2:16 pm by Tom Lamb
Federal Court NuvaRing MDL Bellwether Trial Dates Pushed Back Several Times Previously; Perhaps It Will Be Late 2012 (Posted by Tom Lamb at The first NuvaRing lawsuit has been scheduled to start trial in February 2013 pursuant to In Re: NuvaRing Litigation Case Management Order (CMO) #19. [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 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]
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]
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]
4 May 2012, 2:02 pm by Tom Lamb
A Drug Safety Controversy Continues: Whether It Is The Diabetes Drug Or The Diabetes Which Causes Pancreas Disease (Posted by Tom Lamb at As regards the possible association between Victoza and pancreatitis as a side effect of this diabetes drug from Novo Nordisk, there have quite a few assorted developments during the period April 2011 to April 2012. [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 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]
25 Oct 2010, 11:10 am by Tom Lamb
Novartis Sends "Dear Doctor" Letter To Canadian Physicians With Health Canada Endorsed Safety Information (Posted by Tom Lamb at In 2007 Aclasta (zoledronic acid 5mg) was approved by the FDA under the brand name Aclasta® Injection as the first and only once-yearly medicine for postmenopausal osteoporosis.  [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]
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]