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Personal Injury Law

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

Post Frequency: 0.9/day

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

What Is New In First Half Of 2010 Concerning Atypical Femur Fractures In Patients Using Bisphosphonates

Posted on June 25, 2010
Fosamax, Boniva, And Other Drugs In This Class Are Under Scrutiny Due To This Emerging Drug Safety Issue (Posted by Tom Lamb at DrugInjuryWatch.com) We have reported previously about atypical low-energy femoral, or femur, fractures associated with the long-term use of Fosamax and other bisphosphonates...

June 2010: FDA Launches Its Postmarketing Drug Safety Evaluations Web Site

Posted on June 17, 2010
New FDA Site Will Include A Summary Analysis Of Recently Reported Adverse Events And Related Medical Articles (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-June 2010 the FDA announced that it will be making safety evaluations of postmarket adverse events publicly available on a new web site, Postmarketing Drug Safety Evaluations, and will update the information posted there on a quarterly basis...

Blood Pressure Medication Benicar (Olmesartan) Might Be Unsafe For Some Patients

Posted on June 11, 2010
Two Clinical Studies Find Patients With Type 2 Diabetes Taking Benicar Had Higher Rate Of Death From A Cardiovascular Cause (Posted by Tom Lamb at DrugInjuryWatch.com) On June 11, 2010 the FDA announced that it had issued a safety alert about the blood pressure medication Benicar (olmesartan) which was titled "FDA Drug Safety Communication: Ongoing safety review of Benicar and cardiovascular events"...

June 2010 Update On Several Possible Zocor (Simivastatin) Side Effects

Posted on June 07, 2010
From Myopathy And Rhabdomyolysis To Tendon Ruptures And Interstitial Lung Disease (Posted by Tom Lamb at DrugInjuryWatch.com) The June 2010 FDA Patient Safety News (PSN) includes a video report, "Muscle Injury from High Doses of Zocor", that informs us about a clinical trial which showed the risk of myopathy and rhabdomyolysis is much higher in patients taking 80 mg of Zocor (simvastatin) -- the highest approved dose -- than in those taking a 20 mg Zocor pill...

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June 2010 Update On Several Possible Zocor (Simvastatin) Side Effects

May 2010: New Safety Information For Xenical And Alli Regarding Cases Of Severe Liver Injury

Posted on May 26, 2010
FDA Had Been Investigating Reports Of Hepatotoxicity Involving Their Active Ingredient, Orlistat, For Past Year (Posted by Tom Lamb at DrugInjuryWatch.com) Xenical and Alli are relatively popular medications used for weight-loss that contain different strengths of the same active ingredient, orlistat...

Zithromax-Induced Liver Injury Case Report Involving No History Of Liver Problems

Posted on May 20, 2010
Drug-Induced Liver Injury (DILI), Or Toxicity, Can Cause Both Acute And Chronic Liver Disease (Posted by Tom Lamb at DrugInjuryWatch.com) To get our bearings, we start with some points obtained from the Abstract for "Diagnosis, management and prevention of drug-induced liver injury", which was published in the Gut medical journal last year: Drug-induced liver injury (DILI) is increasingly being recognised as a significant cause of both acute and chronic liver disease...

Zithromax-Induced Liver Injury Case Report Where There Was No History Of Liver Problems

Posted on May 20, 2010
Drug-Induced Liver Injury (DILI), Or Toxicity, Can Cause Both Acute And Chronic Liver Disease (Posted by Tom Lamb at DrugInjuryWatch.com) To get our bearings, we start with some points taken from the Abstract for the article "Diagnosis, management and prevention of drug-induced liver injury", which was published in the Gut medical journal last year: Drug-induced liver injury (DILI) is increasingly being recognised as a significant cause of both acute and chronic liver disease...

Serevent, Advair, and Foradil: Despite The Increased Risk of Severe Asthma Episodes and Death, Monotherapy Use Continues

Posted on May 12, 2010
Numerous Safety Warnings From FDA About These LABA Asthma Drugs Have Seemingly Been Ignored By Patients, According To New Medco Study (Posted by Tom Lamb at DrugInjuryWatch.com) As some of you may recall, back in November 2005 the FDA issued a Public Health Advisory regarding Serevent, Advair, and Foradil to inform doctors and patients that the use of use of inhalation powders containing long-acting beta 2-adrenergic agonists ("LABA") may increase one's risk of severe asthma episodes and death...

Fosamax MDL Litigation Update - May 2010: Maley Case Trial Verdict Goes In Favor Of Merck

Posted on May 06, 2010
Boles Case Retrial Starts On June 2, 2010 And Third Bellwether Trial Is Set For September 2010 (Posted by Tom Lamb at DrugInjuryWatch.com) The first Fosamax verdict was handed down on May 5, 2010 and, because the jury found that plaintiff Louise Maley had not developed bisphosphonate-related osteonecrosis of the jaw (also known as BRONJ or ONJ), Merck won this lawsuit...

April 2010: Senator Chuck Grassley Wants More Independence And Power For FDA Drug-Safety Reviewers

Posted on April 29, 2010
This Idea Has Been Circulating Since The 2005 Grassley-Dodd Bill, With No Real Movement Forward In Past Five Years (Posted by Tom Lamb at DrugInjuryWatch.com) Five years ago, on April 28, 2005, in the very first article I posted to this Drug Injury Watch blog, I wrote about the so-called Grassley-Dodd bill which, in part, would move the FDA's drug-safety office out of the agency's branch: Senator Chuck Grassley (R...

Is Bayer Warning Or Attacking With Its New YAZ / Yasmin Package Insert, Or Label, In The U.S.

Posted on April 22, 2010
Bayer Says YAZ / Yasmin Safety Profile Is Comparable To Older Birth Control Pills, But European Regulators See Possible Increased Risk Of Blood Clot Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) On April 9, 2010 Bayer HealthCare Pharmaceuticals announced that that it will update the labels for YAZ� (3 mg drospirenone / 0...

April 2010 Accutane Update: More Medical Evidence Follows A Large Trial Verdict For Drug Injury Victim

Posted on April 07, 2010
New Study Finds Increased Risk Of Developing Ulcerative Colitis; New Jersey Jury Decides Accutane Caused Man's Inflammatory Bowel Disease (Posted by Tom Lamb at DrugInjuryWatch.com) In the first quarter of 2010 there were two significant developments concerning the acme medication Accutane (isotretinoin)...

Study About Using Glaxo's Avodart To Prevent Prostate Cancer Finds Possible Heart Risk

Posted on April 01, 2010
Higher Rate Of Cardiac Failure In Men Taking Avodart (Dutasteride) ? 0.7 Percent vs. 0.4 Percent For Those Taking The Placebo (Posted by Tom Lamb at DrugInjuryWatch.com) In the April 1, 2010 edition of the New England Journal of Medicine (NEJM) there is an article, "Effect of Dutasteride on the Risk of Prostate Cancer" (free Abstract), which may spell trouble for the efforts of GlaxoSmithKline to get FDA approval for the use of Avodart (dutasteride) to prevent prostate cancer...

March 2010: Bayer Says It Will Update Yasmin Label In Europe To Add Results From Four Medical Studies

Posted on March 30, 2010
Two Newer Studies Found An Increased Venous Thromboembolism (VTE) Risk in Yasmin Users Compared To Levonorgestrel-Containing Birth Control Pills (Posted by Tom Lamb at DrugInjuryWatch.com) In October 2009 we reported that Yasmin and YAZ birth control pills were under scrutiny by drug regulators in Europe...

New Extensively Documented Case Report About Patient With Probable Byetta-Induced Pancreatitis

Posted on March 26, 2010
Numerous Factors, Including Temporal Relation Of Symptoms To Drug Use Dates And A Naranjo Scale Score Of 7/9, Strongly Suggest Byetta Caused This Case Of Acute Pancreatitis (Posted by Tom Lamb at DrugInjuryWatch.com) On March 25, 2010 an article from Endocrine Practice -- 2010;16(1):80-83...

Antibiotic Avelox Linked To Severe Liver Injury Side Effects, Again

Posted on March 23, 2010
Will The FDA Be The Last To Insist On Increased Warning; In Fall 2007 Bayer Updated Its Avalox Label In Europe (Posted by Tom Lamb at DrugInjuryWatch.com) On March 22, 2010 Health Canada issued a press release, "Updated Labelling for Antibiotic Avelox (Moxifloxacin) Regarding Rare Risk of Severe Liver Injury Information Update", which informed doctors and patients about newly updated labelling information for Avelox in Canada that incorporates important safety information related to the rare risk of severe liver problems when using Avelox...

March 2010: FDA Warns About Highest Dose Of Zocor Causing Myopathy And Rhabdomyolysis

Posted on March 19, 2010
Active Ingredient Simvastatin Is Found In Vytorin, With Zetia, And Simcor, With Niacin, Also (Posted by Tom Lamb at DrugInjuryWatch.com) On March 19, 2010 the FDA issued a News Release about Zocor (simvastatin) 80 mg pills which starts as follows: The U...

FDA And Novartis Announce A Label Change For Iron Chelating Drug Exjade In Mid-February 2010

Posted on March 16, 2010
Includes A New "Black Box" Warning About Renal Impairment, Liver Failure, And Gastrointestinal Hemorrhage (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-February 2010 the FDA and Novartis announced a change to the Prescribing Information (PI) -- also referred to as the package insert or label -- for Exjade (deferasirox), a drug indicated for the treatment of chronic iron overload due to blood transfusions in patients two years of age and older...

Some Seroquel Docments From AstraZeneca Now Available At The Drug Industry Document Archive

Posted on March 11, 2010
These 241 "New" Documents Show How Drug Company Obscured Potential For Patient Weight Gain And Diabetes(Posted by Tom Lamb at DrugInjuryWatch.com) In mid-February 2010 Kim Klausner, the Industry Documents Digital Libraries Manager for Drug Industry Document Archive (DIDA) at the University of California, San Franciscolet us know about some "new" that are now available on the DIDA web site: I?m pleased to announce that we?ve added to the Drug Industry Document Archive (http://dida...

Some Seroquel Documents From AstraZeneca Now Available At The Drug Industry Document Archive

Posted on March 11, 2010
These 241 "New" Documents Show How Drug Company Obscured Potential For Patient Weight Gain And Diabetes(Posted by Tom Lamb at DrugInjuryWatch.com) In mid-February 2010 Kim Klausner, the Industry Documents Digital Libraries Manager for Drug Industry Document Archive (DIDA) at the University of California, San Francisco, let us know about some "new" documents concerning the drug Seroquel that are now available on the DIDA web site: I?m pleased to announce that we?ve added to the Drug Industry Document Archive (http://dida...

Recent Report About Ortho Evra Safety Seems To Contradict Earlier Findings From Same Group

Posted on March 08, 2010
Third Boston Collaborative Drug Surveillance Program Study Analysis Concerning Ortho Evra And Blood Clot Side Effect Risk Causes Confusion(Posted by Tom Lamb at DrugInjuryWatch.com) Let us start with this relatively recent medical journal article, "Postmarketing study of ORTHO EVRA and levonorgestrel oral contraceptives containing hormonal contraceptives with 30 mcg of ethinyl estradiol in relation to nonfatal venous thromboembolism", published in the January 1, 2010 edition of Contraception, which reports the findings from a Boston Collaborative Drug Surveillance Program study about the Ortho Evra birth control patch...

YAZ, Yasmin, Ocella: 1,100 Lawsuits Filed As Of Mid-February 2010, According To Bayer

Posted on March 03, 2010
Company Annual Report 2009: "Bayer believes that it has meritorious defenses and intends to defend itself vigorously." (Posted by Tom Lamb at DrugInjuryWatch.com) The Bayer Annual Report for 2009, at page 243, provides some updated information about the number of YAZ, Yasmin, and Ocella lawsuits that have been filed thus far: As of February 15, 2010, there were about 1,100 lawsuits pending in the United States served upon Bayer on behalf of persons alleged to have suffered personal injuries, some of them fatal, from the use of Bayer?s oral contraceptive products Yasmin�, YAZ� and / or Ocella, a generic version...

February 2010: Levaquin MDL Bellwether, Or Test, Cases Selected For First Trials

Posted on March 01, 2010
Six Plaintiffs Selected From Among The 300 Levaquin Lawsuits Filed To Date In Federal Court System (Posted by Tom Lamb at DrugInjuryWatch.com) At a February 12, 2010 Status Conference, U.S. District Judge John R. Tunheim received an update about the number of lawsuits in the federal court multi-district litigation, or MDL -- known as In re: LEVAQUIN PRODUCTS LIABILITY LITIGATION, MDL No...

Generic Drug Manufacturer ETHEX Corp. Is Being Shut Down By KV Pharmceuticals

Posted on February 25, 2010
Troubled Company Pleads Guilty To Criminal Charges, Pay $27.6 Million In Fines And Restitution For Its Conduct Related To Quality-Control Issues (Posted by Tom Lamb at DrugInjuryWatch.com) We last wrote about the troubled generic drug manufacturer ETHEX Corp...

Generic Drug Manufacturer ETHEX Corp. Is Being Shut Down By KV Pharmaceuticals

Posted on February 25, 2010
Troubled Company Pleads Guilty To Criminal Charges, Pays $27.6 Million In Fines And Restitution For Its Conduct Related To Quality-Control Issues (Posted by Tom Lamb at DrugInjuryWatch.com) We last wrote about the troubled generic drug manufacturer ETHEX Corp...

When Considering A Possible Avandia Recall, Liver Injury Side Effects Should Be A Factor

Posted on February 23, 2010
Heart Risk Is Current Focus Due To GlaxoSmithKline Past Conduct; But Public Citizen Has Pointed The Liver Failure Case Reports Linked To Avandia, Also (Posted by Tom Lamb at DrugInjuryWatch.com) As some of you may recall, in October 2008 Public Citizen petitioned the FDA to ban the sale of the diabetes drug Avandia (rosiglitazone) in the U...

Some Fosamax Users Have Had Their Femur Fracture Without Any Fall Or Other Trauma

Posted on February 18, 2010
Reports About Sudden Breaking Of Thigh Bone In Patients Using Fosamax For Five Years Or More (Posted by Tom Lamb at DrugInjuryWatch.com) The side effects of Fosamax include osteonecrosis of the jaw (ONJ), esophageal irritation, and musculoskeletal pain...

How Electronic Medical Records Review Might Help FDA Identify Unsafe Drugs Sooner

Posted on February 15, 2010
Study Says Using Such Data Would Have Resulted In Faster Safety Signal Detection For Increased Risk Of Heart Attacks With Avandia Use (Posted by Tom Lamb at DrugInjuryWatch.com) A recent medical journal article suggests that a systematic review of electronic medical records may have allowed the FDA and others to identify the increased risk for heart attack, or myocardial infarction (MI), with Avandia use as early as 18 months after Avandia came on the market in the U...

Factors In Assessing Association Between Valvular Heart Disease And Use Of Dostinex Or Permax

Posted on February 12, 2010
Two Medical Journal Articles Review The Published Research And Suggest Ways To Avoid Cardiac Valve Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) In March 2007 the FDA announced that Permax (pergolide) would be voluntarily removed from the U...

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