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16 Apr 2012, 12:04 pm by Tom Lamb
QuarterWatch 2011 Quarter 2: More Pradaxa Adverse Events Reported Than Any Other Regularly Monitored Drug (Posted by Tom Lamb at The developing drug safety controversy involving the anticoagulation drug Pradaxa (dabigatran) has been presented best, perhaps, by the ISMP QuarterWatch publication, which served as the basis for these two past articles about the problems with Pradaxa: (1) New Heart Drug Pradaxa May Be Sending "Early" Drug Safety Signals -- ISMP… [read post]
22 Oct 2012, 12:40 pm by Tom Lamb
Combination Pill Of Topamax And Phentremine Was Approved By FDA, But EMA Points To Heart Side Effects, Birth Defects, And Other Safety Issues (Posted by Tom Lamb at On October 18, 2012 European drug regulators took a different course than the FDA with regard to a new anti-obesity medication which contains the active ingredient in Topamax, topiramate, and phentermine. [read post]
5 Dec 2008, 4:00 pm
Many Patients Are Dissatisfied With Lack Of Information From Sandoz, FDA, Or Their Pharmacy About Why This Generic Toprol Pill Was Pulled (Posted by Tom Lamb at In an August 26, 2008 Drug Injury Watch post, "FDA Warns Sandoz About Possible Quality-Control Problems At Its North Carolina Generic Drug Manufacturing Facility", I reported FDA inspectors found that Sandoz had failed to properly validate its manufacturing process for Metoprolol Succinate… [read post]
8 Mar 2011, 7:54 am by Tom Lamb
Oral Clefts In Babies Are 20 Times More Likely With Women Who Used Topamax (topiramate) After Getting Pregnant (Posted by Tom Lamb at In early March 2011 the FDA announced that the prescribing information for Topamax and generic topiramate products would be changed to warn women and their doctors about an increased risk of oral cleft birth defects in children whose mothers used these epilepsy and migraine drugs during pregnancy. [read post]
24 Feb 2012, 2:08 pm by Tom Lamb
The Flores Case And The Sessner Case Involve Incidents Of ONJ Jaw Injury, Not The Femur Fracture Side Effect (Posted by Tom Lamb at ______________________________________________________________________________ UPDATE: During pretrial hearings Judge Higbee severed the Flores case from the Sessner case.  [read post]
15 Mar 2012, 11:40 am by Tom Lamb
820 Cases Are Filed In Federal Court NuvaRing MDL And 125 Lawsuits Are Part Of New Jersey State Court Mass Tort (Posted by Tom Lamb at The following information about the number of NuvaRing lawsuits that had been filed before January 2012 comes from page 119 of the Merck & Co., Inc. [read post]
4 Apr 2011, 1:15 pm by Tom Lamb
Merck ONJ Trial Set For May 2011 (Posted by Tom Lamb at _____________________________________________________________________UPDATE: On May 23, 2011 the U.S. [read post]
23 Nov 2011, 1:13 pm by Tom Lamb
Analysis Of PALLAS Study Data Shows Two-Times Increased Risk Of Death, Stroke, And Heart Attack (Posted by Tom Lamb at ______________________________________________________________________________ UPDATE:  FDA Drug Safety Communication: Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events Safety Announcement [12-19-2011] The U.S. [read post]
9 Aug 2007, 9:31 am
AstraZeneca Study Information Provided To Regulatory Agencies In May 2007 Currently The Subject of Their Ongoing Safety Reviews (Posted by Tom Lamb at On August 9, 2007 the FDA and Health Canada issued email alerts about possible serious cardiac events in patients using the prescription heartburn drugs Nexium (esomeprazole) and Prilosec (omeprazole), made by AstraZeneca (AZN). [read post]
8 Sep 2011, 11:04 am by Tom Lamb
Osteonecrosis Of The Jaw, Or Jawbone Death, And Atypical Femur Fractures, Or Low-Stress Thigh Bone Breaks, Are The Primary Drug-Safety Issues (Posted by Tom Lamb at ______________________________________________________________________________ UPDATE:  Warner, Merck Bone Drugs Need Label Changes on Use Duration, Panel Says (9/9/11, Bloomberg) FDA Panel: Osteoporosis Drugs Need Better Labels (9/9/11, WebMD Health News)Time Limits on the Drugs Are Suggested,… [read post]
21 Jan 2008, 2:50 pm
Pfizer Increases Warning About Abnormal Behavior Of Patients Using Its Smoking Cessation Medication In January 2008 (Posted by Tom Lamb at On November 20, 2007 the FDA issued an "Early Communication About an Ongoing Safety Review Varenicline (marketed as Chantix)" to inform healthcare providers about reports the agency had received of people exhibiting various types of abnormal behaviors while using Chantix. [read post]
13 Dec 2007, 10:16 am
Serious Adverse Reactions With This Vaginal Ring Birth Control Device Include Deep Vein Thrombosis (DVT) And Pulmonary Emboli (PE) (Posted by Tom Lamb at An abstract from the annual meeting of the American Society of Hematology (ASH) entitled "Venous Thromboembolic Events in Women Using the NuvaRing ®. [read post]
24 Nov 2010, 10:57 am by Tom Lamb
Johnson and Johnson: Man Ruptured Achilles Tendons In Both Feet After Taking Levaquin (Posted by Tom Lamb at _____________________________________________________________________________ UPDATES: "J&J Loses First Trial on Warnings of Levaquin Risk" (12/8/10, Bloomberg) "Johnson & Johnson Warned on Levaquin Risk, Lawyer Says [During Closing Argument]" (12/6/10, Bloomberg) "Schedin v. [read post]
2 May 2011, 1:12 pm by Tom Lamb
April 2011 Edition Of BMJ Breaks News And Provides Insight From One Who Saw An Increased Risk Of Pancreatitis  (Posted by Tom Lamb at According to a news item published April 11, 2011 by The British Medical Journal (BMJ), letters written by Merck and Novo Nordisk to Anil Rustgi, the editor-in-chief of Gastroenterology, resulted in that journal withdrawing an article which it had posted on its website about how Januvia (sitagliptin) and Byetta (exenatide)… [read post]
28 Apr 2008, 9:03 am
After Their Medications Get Approved By FDA, Many Drug Companies Have Not Yet Started The Studies Which They Promised To Do (Posted by Tom Lamb at Each year the FDA issues what could be called a "report card" on how the pharmaceutical companies are doing as regards post-approval studies for their products that have been approved for sale in the U.S. [read post]
14 Feb 2008, 2:44 pm
January 2008 Health Canada Newsletter Presents These Adverse Reaction Cases, And Announces "Canada Vigilance" (Posted by Tom Lamb at The Canadian Adverse Reaction Newsletter (CARN), in its January 2008 edition (Volume 18, Issue 1), has two articles of interest regarding side effects associated with birth control products that are alternatives to oral contraceptives. [read post]
6 Dec 2011, 8:55 am by Tom Lamb
Expert Reports From YAZ / Yasmin Lawsuits Will Not Be Considered Because Submitted After Deadline Set By FDA (Posted by Tom Lamb at _____________________________________________________________________ UPDATE:  "Bayer Birth Control Pill Benefits Outweigh Risks, Panel Says" (12/8/11, Bloomberg) (12/12/11) _____________________________________________________________________ In October 2011 the FDA released its new drug-safety study report, "Combined Hormonal… [read post]
12 May 2009, 6:55 am
These New Cases Involve Premixed IV Bags of Heparin And Initial Tests Did Not Detect Oversulfated Chondroitin Sulfate Contamination (Posted by Tom Lamb at The headline used by the Wall Street Journal (WSJ), "Heparin Stirs New Fears", alluded to last year's heparin-illness outbreak when roughly 80 deaths were linked to contaminated heparin and led to a recall of the medicine from several companies. [read post]
5 Nov 2012, 12:59 pm by Tom Lamb
More Findings About Atypical Femoral Fractures And The Use Of Fosamax Or Other Bisphosphonate Therapy For Osteoporosis (But Often Osteopenia) (Posted by Tom Lamb at In the fall of 2012 we have two more medical journal articles about Fosamax-related femur fractures, with each taking a different perspective on this still-emerging drug safety / side-effects issue. [read post]
28 Jan 2010, 2:00 pm by Tom Lamb
(Posted by Tom Lamb at On January 21, 2010 the Health Research Group arm of Public Citizen sent its "Petition to Ban Fibromyalgia Drug Milnacipran (Savella)" to FDA Commissioner Margaret Hamburg, M.D.  [read post]