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Drug Injury Watch

Provides developing information about prescription drug side effects as well as up-to-date news from the legal, medical, FDA, and pharmaceutical sectors.
By Tom Lamb

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Last Entry: October 30, 2020 at 16:30:00

Case Report: Man Using Diabetes Medication Januvia Develops Elevated Hepatic Enzymes

Posted on February 08, 2010
Authors Suggest That Certain Patients Starting Januvia Should Have Their Liver Function Monitored (Posted by Tom Lamb at DrugInjuryWatch.com) In the recent past we considered whether Januvia (sitagliptin) can cause pancreatitis in patients using this relatively new diabetes medication...

There Is Disagreement Over The Three-Year Failure Rate For Sprint Fidelis Lead Wires

Posted on February 04, 2010
Medtronic Says 4.6 Percent Of Leads Failed, While Reports From Some Hospitals Indicate 9.2 Percent Of Sprint Fidelis Wires Failed (Posted by Tom Lamb at DrugInjuryWatch.com) In our December 30, 2009 article, "Sprint Fidelis Lead Wire Failure Rate Could Rise To 30 Percent By Four Years", we provided the little bit of information we could find, then, about the future failure rates for the Medtronic Sprint Fidelis lead wires that were removed from the market back in 2007: A report by UBS Investment Research Monday said lead failures could accelerate over time, citing independent studies that predict failure rates could...

February 2010: Fosamax Federal Court MDL Litigation Update; Next Trial Starts In Mid-April

Posted on February 02, 2010
Merck Lost Its Attempt To Have Louise Maley's Fosamax Lawsuit Dismissed Before Her April 19, 2010 Trial Date (Posted by Tom Lamb at DrugInjuryWatch.com) We have been reporting about the three bellwether trial cases for the federal court Fosamax MDL and, in this article, we continue to do so...

Fibromyalgia Drug Savella Should Be Pulled From Market, Says Public Citizen Group

Posted on January 28, 2010
January 2010 Petition Letter To FDA Was Sent One Year After The Medication Was Approved For Sale In U.S. (Posted by Tom Lamb at DrugInjuryWatch.com) 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...

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Should Meridia Remain On Market? FDA Says "Yes" (For Now At Least), European Drug Regulators Say "No"

Posted on January 25, 2010
Difference Of Opinion Suggests There Could Be A Possible Meridia Recall In U.S. Before The FDA Holds Its Public Advisory Meeting In September 2010 (Posted by Tom Lamb at DrugInjuryWatch.com) The beginning of a January 23, 2010 newspaper article, "Heart Patients Warned Against Using Meridia, an Anti-Obesity Drug" -- by Natasha Singer and Andrew Pollock for The New York Times (NYT) -- frames the issue: European and American drug regulators had two starkly different reactions this week to data on an obesity drug...

National Alert Network For Serious Medication Errors: New Drug-Safety Project From ISMP And ASHP

Posted on January 20, 2010
Will Send Email Alerts To Healthcare Providers When Dangerous Or Life-Threatening Prescription Drug Errors Are Reported To ISMP (Posted by Tom Lamb at DrugInjuryWatch.com) A January 19, 2010 article, "Catching Deadly Drug Mistakes", by The Wall Street Journal's health reporter, Laura Landro, brought to our attention a new project intended to reduce medication errors...

When Will Michigan State Senate Vote Whether To Repeal Statute Prohibiting Drug Injury Lawsuits

Posted on January 18, 2010
State Senate Republicans Move In January 2010 To Delay, Again, Any Action Regarding This "FDA Defense" Law (Posted by Tom Lamb at DrugInjuryWatch.com) As you may be aware, Michigan is the only state in the country that has a statute, or law, which serves to shield pharmaceutical companies from drug injury lawsuits...

Safety "Cloud" Gets Removed From Spiriva By FDA In January 2010

Posted on January 15, 2010
This COPD Medication Had Previously Been Possibly Linked To Stroke, Heart Attack, And Death (Posted by Tom Lamb at DrugInjuryWatch.com) On January 14, 2010 the FDA issued a news release, "FDA Updates Earlier Guidance on Respiratory Treatment Spiriva HandiHaler -- Current data do not support increased risks for stroke, heart attack, or death", which began as follows: The U...

FDA Introduces A New Web Site Intended To Give The Public More Insight About Agency's Work

Posted on January 12, 2010
FDA Basics: Site Seeks To Present Information To Consumers And Patients In Useful And User-Friendly Format (Posted by Tom Lamb at DrugInjuryWatch.com) On January 12, 2009 Dr. Joshua Sharfstein, Principal Deputy Commissioner of the FDA, introduced FDA Basics, which is a new Web resource intended to answer questions from consumers and patients as well as to discuss other important public health topics in a useful and user-friendly format...

GE Healthcare Seemingly Tries To Intimidate And Silence A Critic Of Its Omniscan Product

Posted on January 11, 2010
Drug Company Files Libel Lawsuit In UK Against Prominent Danish Radiologist Henrik Thomsen (Posted by Tom Lamb at DrugInjuryWatch.com) The Sunday Times (UK) recently ran a story that demonstrates how Britain's libel laws are possibly being used by GE Healthcare to intimidate a prominent Danish radiologist, Henrik Thomsen, M...

FDA Wants Studies Done On Byetta Safety, With Focus On Pancreatitis, Pancreatic Cancer, Thyroid Neoplasm, And Acute Renal Failure

Posted on January 06, 2010
FDA Letter About Byetta Sent To Amilyn In October 2009; Drug Company Tries To Downplay, But Investors React When They Learn About It In December 2009 (Posted by Tom Lamb at DrugInjuryWatch.com) On October 30, 2009 Amylin Pharmaceuticals Inc. issued a press release, "BYETTA Approved for Expanded Use as First-Line Treatment for Type 2 Diabetes Prescribing Information Also Includes Updated Safety Information", in which they announced that the FDA had approved an expanded indication for BYETTA� (exenatide) injection: BYETTA is now approved for use as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults...

Levaquin Has Been Associated With Dysglycemia Events Such As Hyperglycemia And Hypoglycemia

Posted on January 04, 2010
North Carolina Case Report: Man With Diabetes Develops Low Blood Sugar After Using Levaquin Together With Glucotrol (Posted by Tom Lamb at DrugInjuryWatch.com) Three years ago to the day we posted an article, back in January 2007, about the fact that Health Canada had received several reports of patients developing blood sugar problems after using Levaquin (levofloxacin) over the period January 1997 to June 2006...

Sprint Fidelis Lead Wire Failure Rate Could Rise To 30 Percent By Four Years

Posted on December 30, 2009
About 260,000 Medtronic Sprint Fidelis Leads Were Implanted In US, With Approximately 143,000 Still Active (Posted by Tom Lamb at DrugInjuryWatch.com) The December 28, 2009 edition of "US Morning Meeting Highlights" from UBS Investment Research brought some relatively grim news for patients who have a defibrillator with a Sprint Fidelis lead wire...

A New Year's Resolution For The FDA, As Recommended By The GAO

Posted on December 23, 2009
FDA Needs To Restructure Its Staff In Order To Better Monitor Emerging Drug Safety Issues (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-December 2009 the Government Accounting Agency (GAO) -- often referred to as the federal government's watchdog agency -- issued a report which was critical of the slow rate of change at the FDA as regards better monitoring of drug safety issues...

FDA Finds It Unlikely Than Vytorin Or Zetia Increases Risk Of Cancer, But Such A Link Is Possible

Posted on December 22, 2009
December 2009 Update From FDA For Its August 2008 Early Communication About Safety Review of Ezetimibe / Simvastatin (Vytorin) And Ezetimibe (Zetia) (Posted by Tom Lamb at DrugInjuryWatch.com) On December 22, 2009 the FDA issued an update about its August 2008 Early Communication which described a possible association between the use of Vytorin ? a combination of simvastatin (Zocor) and ezetimibe (Zetia) ? and an increased risk of cancer and cancer-related death compared to placebo...

Digitek Federal Court MDL Judge Sets Joint Hearing To Address Scientific And Technical Issues For October 2010

Posted on December 18, 2009
Judge Goodwin Will Be Joined By State Court Judges Overseeing Digitek Consolidations In New Jersey, Pennsylvania, Texas, And West Virginia At This Daubert Hearing(Posted by Tom Lamb at DrugInjuryWatch.com) On December 18, 2009 Joseph F. Goodwin, Chief Judge for the United States District Court, Southern District of West Virginia, issued Pretrial Order #48 for In Re Digitek� Product Liability Litigation MDL No...

Bisphosphonates Such As Fosamax And Femur Fractures: Some Recent 2009 Medical Journal Articles

Posted on December 16, 2009
Atypical Low-Energy Femoral Fractures Associated With Long-Term Use Of Fosamax And Other Bisphosphonates (Posted by Tom Lamb at DrugInjuryWatch.com) The Journal Watch General Medicine (JW Gen Med) published December 15, 2009 included an article, "Atypical Fractures in Long-Term Bisphosphonate Users" (subscription required), by Allan S...

December 2009: Voltaren Gel And Other Products Containing Diclofenc Sodium Linked To Liver Problems

Posted on December 11, 2009
"Dear Doctor" Letter From Endo And Novartis Offers Information About Prevention And Diagnosis Of Drug-Induced Liver Injury (DILI) (Posted by Tom Lamb at DrugInjuryWatch.com) On December 4, 2009 the FDA issued this MedWatch alert, "Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes", which provided news about an emerging drug safety issue concerning all products containing diclofenac sodium, including Voltaren Gel...

Medical Journal Report: Adverse Drug Reactions And Pulmonary Embolism Are Often Difficult For Doctors To Diagnose

Posted on December 08, 2009
These Commonly Missed Diagnoses Are Particularly Relevant To Women Using YAZ, Yasmin, And Ocella, As Well As NuvaRing And Ortho Evra (Posted by Tom Lamb at DrugInjuryWatch.com) The November 9, 2009 issue of the Archives of Internal Medicine included an article, "Diagnostic Error in Medicine -- Analysis of 583 Physician-Reported Errors", which should be of particular interest to women using the following birth control products: YAZ / Yasmin / Ocella; NuvaRing; and, Ortho Evra...

November 2009: Osteonecrosis Of The Jaw (ONJ) And Fosamax: Four Recent Medical Journal Articles

Posted on December 02, 2009
This List Of Abstracts Provides Various Perspectives About ONJ, A Jaw Bone Side Effect Caused By Bisphosphonates (Posted by Tom Lamb at DrugInjuryWatch.com) In this brief article we provide a quick round-up of medical journal articles published in November 2009 that address different aspects of how osteonecrosis of the jaw (ONJ) can develop in patients using bisphosphonates, a class of drugs which includes Fosamax...

Diet Drug Meridia Has Possible Cardiovascular Risks, Including Stroke, Heart Attack, And Cardiac Death

Posted on November 30, 2009
FDA Early Communication About Meridia (Sibutramine) Side Effects Issued by Agency In November 2009 (Posted by Tom Lamb at DrugInjuryWatch.com) On November 20, 2009 the FDA issued an "Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride)" to let patients and their doctors know about a possible increased risk for adverse cardiovascular events associated with the obesity drug Meridia...

November 2009 Medical Journal Article Describes Large Ongoing Study About Safety Of YAZ

Posted on November 24, 2009
INAS-OC Study: Intended To Evaluate Risk Of Developing Cardiovascular Side Effects For Women Who Use YAZ (DRSP/EE 24d) (Posted by Tom Lamb at DrugInjuryWatch.com) In May 2009 we first wrote about the International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC Study), which is intended to evaluate the risk of developing cardiovascular side effects for women who use YAZ, a popular birth control containing a unique progestin, drospirenone (DRSP), and a relatively low dose of an estrogen, ethinylestradiol (EE)...

Drug Industry Document Archive (DIDA) Adds 15 More Pharma-Related Documents To Collection In November 2009

Posted on November 20, 2009
This Archive Contains Some "Secret" Documents Only Made Public In The Course Of Lawsuits Filed Against Pharmaceutical Companies (Posted by Tom Lamb at DrugInjuryWatch.com) Created and maintained by the University of California at San Francisco (UCSF), the Drug Industry Document Archive (DIDA) contains over 1500 documents, many of which were previously secret and only made public as a result of lawsuits filed against drug companies...

Consumers Union?s Safe Patient Project Forum Webcast: ?To Err Is Human, To Delay Is Deadly?

Posted on November 17, 2009
Marks 10th Anniversary Of IOM Study On Medical Errors And Raises Concerns About Lack Of Progress (Posted by Tom Lamb at DrugInjuryWatch.com) The Consumers Union?s Safe Patient Project (formerly Stop Hospital Infections) is holding a forum, ?To Err Is Human, To Delay Is Deadly,? in Washington, DC, today, Tuesday, November 17, 2009, from 10 a...

Anemia Drugs Procrit And Aranesp May Increase Twofold The Risk Of Potentially Fatal Blood Clots

Posted on November 11, 2009
Results From Large Long-Term Study Show Association Between These Erythropoiesis-Stimulating Agents And Venous Thromboembolism(Posted by Tom Lamb at DrugInjuryWatch.com) In late October 2009 we learned that the results from the Trial to Reduce Cardiovascular Events with Aransep Treatment (TREAT) indicated that the anemia drug Aranesp might cause an increased risk for stroke in patients with diabetes and chronic kidney disease...

Aranesp Associated With Increased Risk For Stroke In Patients With Diabetes And Chronic Kidney Disease

Posted on November 06, 2009
TREAT Study Revealed, Also, That This Amgen Anemia Drug Was No Better Than Placebo In Reducing Deaths Or Cardiovascular Problems (Posted by Tom Lamb at DrugInjuryWatch.com) The anemia drug Aranesp (darbepoetin alfa) might cause an increased risk for stroke in patients with diabetes and chronic kidney disease, according to the results from the Trial to Reduce Cardiovascular Events with Aransep Treatment (TREAT), a new study that was published in the October 30, 2009 edition of the New England Journal of Medicine (NEJM) and presented recently at the annual meeting of the American Society of Nephrology...

Diabetes Drug Byetta Linked To Kidney Problems And Cases Of Renal Failure

Posted on November 03, 2009
October 2009 Byetta Label Change Follows Earlier Alert From U.K. About Kidney-Related Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) In March 2009 the Drug Safety Update Newsletter alerted us about reports of kidney-related side effects associated with the use of the diabetes drug Byetta (exenatide) from the U...

FDA Should Make Drug Efficacy And Safety Information More Accessible To Patients

Posted on October 27, 2009
Package Inserts Prepared By Drug Companies Which Exagerrate Benefits And Downplay Risks Need To Be Addressed (Posted by Tom Lamb at DrugInjuryWatch.com) In the October 21, 2009 edition of The New England Journal of Medicine (NEJM) there is a Perspective piece, ?Lost in Transmission ? FDA Drug Information That Never Reaches Clinicians?, by Lisa M...

Yasmin And Yaz Birth Control Pills Are Under Scrutiny By Drug Regulators In Europe

Posted on October 22, 2009
Bayer Confirms To German Newspaper There Are 129 Yasmin / Yaz Lawsuits In U.S. As Of Mid-October 2009 (Posted by Tom Lamb at DrugInjuryWatch.com) From an October 21, 2009 article, "Bayer under pressure as birth control pills linked to blood clots", published by the German newspaper Deutsche Welle, we learn that the popular birth control pills Yasmin and Yaz have come under scrutiny in Europe as well as in the United States...

Popular Asthma Medicine Singulair Associated With Psychiatric Disorders In Children

Posted on July 04, 2009
New Medical Journal Article Follows June 2009 FDA-Required Warning For Singulair About Neuropsychiatric Events (Posted by Tom Lamb at DrugInjuryWatch.com) On June 12, 2009 the FDA announced a new warning about an increased risk of neuropsychiatric events for the asthma...

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