Personal Injury Law

Beovu Lawsuits Filed Against Novartis for Patients Who Have Suffered Vision Loss Side Effects

Posted on October 30, 2020
Beovu Legal Cases Involve Retinal Artery Occlusion, Retinal Vasculitis, Intraocular Inflammation, Other Eye Problems (Posted by Tom Lamb at DrugInjuryWatch.com) Beovu (brolucizumab) is prescribed for the treatment of neovascular (wet) age-related macular degeneration (AMD)...

Picato Recalls Continue with Canada and Denmark Being Most Recent, All Due to Risk of Skin Cancer

Posted on October 29, 2020
A Global Phase-out of Picato Sales by LEO Pharma Inc. Due to this Picato Safety Finding Expected by End of 2020 (Posted by Tom Lamb at DrugInjuryWatch.com) On October 27, 2020 Health Canada announced a Picato recall due to a the Picato safety finding "that there may be a link between PICATO and an increased risk of non-melanoma skin cancer", as explained in this document: "PICATO (ingenol mebutate gel, 0...

Drug Safety Issue for Stelara: Severe Cardiovascular Events Soon After Initiation of Stelara Treatment

Posted on October 22, 2020
Stelara-Associated Acute Coronary Syndrome, Stroke, and Unstable Angina Seen in Recent Stelara French Medical Study (Posted by Tom Lamb at DrugInjuryWatch.com) Stelara (ustekinumab) was approved by the FDA in 2009, initially for Crohn's Disease and Psoriatic Arthritis, then Ulcerative Colitis in October 2019 and Psoriasis in July 2020...

Ocaliva FDA Adverse Events Reports for Hepatobiliary System Cases: An Analysis as of October 2020

Posted on October 15, 2020
Lack of Warnings in Current Ocaliva Drug Label for Some Serious Side Effects Involving Liver, Gallbladder, Bile Ducts (Posted by Tom Lamb at DrugInjuryWatch.com) We are still wondering how the current FDA investigation of an Ocaliva safety signal -- said to be involving a potential liver disorder risk -- was able to fly below the radar for five months before first being reported in early October 2020...

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Potential Ocaliva - Liver Disorder Safety Signal Being Investigated by FDA as Side Effects Risk

Posted on October 12, 2020
October 2020 News Report Reveals "New" Ocaliva Liver Safety Issue, Which Had Been Under the Radar Previously (Posted by Tom Lamb at DrugInjuryWatch.com) Ocaliva (obeticholic acid) was approved by the FDA in 2016 for the treatment of a rare chronic liver disease, primary biliary cholangitis (PBC)...

A Closer Look at the Vision-Related Side Effects Warnings Added with June 2020 Beovu Label Change

Posted on October 06, 2020
New Beovu Warnings for Endophthalmitis and Retinal Detachment as well as Retinal Vasculitis, Retinal Vascular Occlusion (Posted by Tom Lamb at DrugInjuryWatch.com) In June 2020 Novartis revised the Prescribing Information for Beovu to add new warnings for some vision-related side effects linked to Beovu...

Beovu: Should Use of This Eye Drug be Suspended Until Safety Investigation is Finished?

Posted on September 29, 2020
Numerous Case Reports of Occlusive Retinal Vasculitis and Vision Loss in Patients Following Beovu Injections (Posted by Tom Lamb at DrugInjuryWatch.com) As early as May 2020 it was suggested by the authors of an Editorial piece published online by the American Journal of Ophthalmology that the use of Beovu injections should be suspended until the underlying cause of Beovu-associated inflammation is discovered...

Safety of Beovu: A Lingering Issue Which Novartis Attempts to Counter with Recent Study Results

Posted on September 22, 2020
Recent Beovu Label Change in Europe Adds Information About Retinal Vasculitis and Retinal Vascular Occlusion (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-September 2020 Novartis announced the results of a Phase 3 head-to-head study comparing its relatively new eye medicine Beovu to Eylea, a more well-established competing eye drug product from Regeneron...

Report on FDA Belviq Recall Decision Provides New Information About Excess Cancers Risks

Posted on September 17, 2020
Belviq Safety Data Review Found Higher Rates of Colorectal Cancer, Pancreatic Cancer, and Lung Cancer (Posted by Tom Lamb at DrugInjuryWatch.com) The FDA's decision to request that the pharmaceutical company Eisai recall its oral weight-loss drugs Belviq and Belviq XR (lorcaserin) earlier this year has been more fully explained in a new medical journal article written by FDA staff...

Drug Safety Issue: Elmiron Side Effects Risks for Eye and Vision Appear to be Greater Than Bladder Treatment Benefits

Posted on September 10, 2020
Patients Consider Whether Relief from Bladder Pain is Worth Possibility of Elmiron-Associated Maculopathy and Other Eye Problems (Posted by Tom Lamb at DrugInjuryWatch.com) Approved by the FDA way back in 1996, Elmiron (pentosan polysulfate sodium / "PPS") is prescribed for treatment of interstitial cystitis ("IC"), also known as ?bladder pain syndrome? or ?painful bladder syndrome?...

Elmiron-Related Eye Problems Are Causing Patients to File Elmiron Lawsuits Against Pharmaceutical Companies

Posted on September 02, 2020
Medical Studies Find Elmiron "significantly increased odds of having atypical maculopathy" Such as Pigmentary Maculopathy (Posted by Tom Lamb at DrugInjuryWatch.com) Elmiron (pentosan polysulfate sodium / "PPS") was approved by the FDA in 1996 for the treatment of interstitial cystitis ("IC"), also known as ?bladder pain syndrome? or ?painful bladder syndrome?...

Vascular Endothelial Growth Factor (VEGF) Inhibitors: Increased Risk Of Aneurysm And Artery Dissection

Posted on August 13, 2020
New Warnings Added To Drug Labels For All VEGF Inhibitors By UK's MHRA Already; FDA Is Evaluating Need For Regulatory Action (Posted by Tom Lamb at DrugInjuryWatch.com) On July 31, 2020 the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) issued this Drug Safety Update, "Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection", which began as follows: Before initiating systemic vascular endothelial growth factor (VEGF) pathway inhibitors, carefully consider the risk of aneurysm and artery dissection in patients with risk factors...

Beovu Retinal Vasculitis Case Report Is Presented In August 2020 Medical Journal Article

Posted on August 07, 2020
Woman Developed Acute And Severe Loss Of Visual Acuity Following Her Second Beovu Injection (Posted by Tom Lamb at DrugInjuryWatch.com) Beovu (brolucizumab) was approved by the FDA in 2019 for the treatment of neovascular (wet) age-related macular degeneration (AMD)...

Possible Beovu Side Effects Discussed At American Society of Retina Specialists Annual Meeting In July 2020

Posted on July 28, 2020
Current Findings On Risks Of Occlusive Vasculitis And Vision Loss Following Beovu Injections For Treatment Of Wet AMD (Posted by Tom Lamb at DrugInjuryWatch.com) According to news reports, Beovu safety issues were a dominant topic at the American Society of Retina Specialists (ASRS) annual meeting which was held virtually July 24-26, 2020...

Picato May Increase The Risk Of Skin Cancer As Side Effect, Says Drug Regulator Health Canada In July 2020

Posted on July 14, 2020
Picato Skin Cancer Risk Has Been Confirmed By European Drug Regulator; The FDA Is Still Investigating This Picato Safety Issue (Posted by Tom Lamb at DrugInjuryWatch.com) The topical gel drug Picato (ingenol mebutate), which is prescribed for the treatment of actinic keratosis, or solar keratosis, has been under the scrutiny of drug regulators around the world since the start of 2020...

Beovu Safety Signal Found By External Review Committee Which Evaluated Beovu Post-Marketing Adverse Events

Posted on July 01, 2020
New Vision-Related Side Effects Warnings For Beovu Eye Injections Have Been Added In US, Australia, And Switzerland, Thus Far (Posted by Tom Lamb at DrugInjuryWatch.com) In this recent article, "Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020", we pointed out that the HAWK & HARRIER clinical trials were a significant factor leading to the new warnings for Beovu eye injections about retinal vasculitis and retinal vascular occlusion...

730 NuvaRing Lawsuits Filed As Of December 31, 2010 Per Merck Annual Report

Posted on March 28, 2011
610 Cases Were In Federal Court NuvaRing MDL And 110 Complaints Filed In New Jersey State Court (Posted by Tom Lamb at DrugInjuryWatch.com) The following information about the number of NuvaRing lawsuits that had been filed before January 2011 comes from page 129 of the Merck & Co...

Another Rather "Odd" YAZ Label Change By Bayer: March 2011

Posted on March 21, 2011
Provides New Warnings About Certain Side Effects As Regards ALL Birth Control Pills (Not Specific To YAZ) (Posted by Tom Lamb at DrugInjuryWatch.com) The bottom line is this: There is nothing specific about YAZ in the new warning language added to the YAZ label by Bayer in March 2011...

Generic Drug Company Should Not Be Allowed To Use Federal Preemption To Defeat Lawsuits

Posted on March 14, 2011
U. S. Supreme Court Will Hear Oral Arguments On This Legal Issue In Drug Injury Lawsuit Involving Gladys Mensing (Posted by Tom Lamb at DrugInjuryWatch.com) On March 30, 2011 the U.S. Supreme Court will hear oral arguments in a drug injury case which presents this important legal issue: Whether federal law preempts a tort claim under state law that a generic drug approved by the Food and Drug Administration was inadequately labeled...

Topamax During Pregnancy Increases Risk Of Cleft Lip And/Or Cleft Palate Birth Defects

Posted on March 08, 2011
Oral Clefts In Babies Are 20 Times More Likely With Women Who Used Topamax (topiramate) After Getting Pregnant (Posted by Tom Lamb at DrugInjuryWatch.com) 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...

Zithromax Label Adds Warning About Drug-Induced Liver Injury In February 2011

Posted on March 03, 2011
Adverse Reactions And Warnings Sections Now Include Hepatotoxicity, From Hepatic Dysfunction To Liver Failure (Posted by Tom Lamb at DrugInjuryWatch.com) The association between the antibiotic Zithromax (azithromycin) and drug-induced liver failure first received some real attention in 2010...

Thigh Bone Leg Fractures In Older Women Using Fosamax, Boniva, And Reclast For Five Years Or More

Posted on February 23, 2011
Long-Term Bisphosphonate Use Linked To Subtrochanteric And Femoral Shaft Fractures, Also Called Femur Fractures (Posted by Tom Lamb at DrugInjuryWatch.com) An article published in the February 23, 2011 edition of the medical journal JAMA (Journal of the American Medical Association) reports on research finding that older women who used Fosamax, Boniva, Reclast, or other bisphosphonate drugs had a significant increased risk of suffering leg fractures involving their thigh bone, or femur...

YAZ / Yasmin / Ocella Litigation: February 2011 Update

Posted on February 16, 2011
The Number Of Birth Control Lawsuits Filed Against Bayer Now Exceeds 6000 (Posted by Tom Lamb at DrugInjuryWatch.com) The number of YAZ, Yasmin, and Ocella lawsuits filed on behalf of women who have developed a blood clot-related side effect, such as pulmonary embolism (PE) or deep vein thrombosis (DVT), as well as those who have had to undergo gallbladder removal surgery now exceeds 6000...

Fosamax MDL Judge Wants Two More Bellwether Cases Selected Per February 2011 Order

Posted on February 08, 2011
In Addition To The Federal Court Fosamax Jaw Injury Cases Set For Trial In March 2011 And May 2011 (Posted by Tom Lamb at DrugInjuryWatch.com) On February 4, 2011 Judge John F. Keenan, presiding over the federal court Fosamax multi-district litigation (MDL) pending in the Southern District of New York (Manhattan, NYC), issued an order calling for two additional "bellwether", or test, cases involving osteonecrosis of the jaw (ONJ) to go to trial...

FDA Seeks Information About Topamax-Related Oral Cleft Birth Defect Cases

Posted on February 01, 2011
Request For Historical Incidence Data Made In Connection With NDA For New Obesity Drug (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-January 2011 the biopharmaceutical company Vivus, Inc. -- while providing a regulatory update on its New Drug Application (NDA) for QNEXA -- announced that the FDA had asked the company to look into the possibility that the drug Topamax (topiramate) is associated with a certain type of birth defect, oral cleft...

First Fosamax Trial Against Merck In New Jersey State Court Starts In January 2011

Posted on January 24, 2011
This Rosenberg v. Merck Case Involves Woman Who Alleges She Developed Osteonecrosis Of The Jaw (ONJ) (Posted by Tom Lamb at DrugInjuryWatch.com) On January 18, 2011 the first Fosamax trial involving bisphosphonate-related osteonecrosis of the jaw (ONJ) started in the Superior Court for Atlantic County...

Sanofi-Aventis "Dear Doctor" Letter Will Warn Heart Drug Multaq Associated With Liver Failure

Posted on January 14, 2011
Liver Toxicity And Cardiac Side Effects Cause Dr. Steven Nissen To Express "concerns about the safety, efficacy and tolerability of dronedarone" (Posted by Tom Lamb at DrugInjuryWatch.com) On January 13, 2011 reporter Larry Husten posted on Cardiobrief...

Psoriasis Drug Raptiva Alleged To Have Caused Hodgkin's Lymphoma Just Before April 2009 Recall

Posted on January 13, 2011
2011 Raptiva Lawsuit Filed In Texas Against Drug Company: Failure To Warn About Side Effect Risks (Posted by Tom Lamb at DrugInjuryWatch.com) Back in 2009, we told you about some of the developments which led to Raptiva being withdrawn from the market in these two articles: -- A Timeline For The Psoriasis Drug Raptiva, From Product Launch In U...

Fertility Drugs Clomid And Serophene Have Long Been Associated With Birth Defects

Posted on January 07, 2011
Should These Drugs Have Stronger Warning About Increased Risk Of Fetal Abnormality After Clomiphene Use? (Posted by Tom Lamb at DrugInjuryWatch.com) Clomiphene is a prescription drug used for more than thirty years, now, to induce ovulation (egg production) in women who do not produce ova (eggs) but wish to become pregnant (infertility)...

Stevens-Johnson Syndrome And Toxic Epidermal Necrolysis Are Serious Drug-Induced Skin Reactions

Posted on December 30, 2010
SJS And TEN Differ In The Extent Of Skin Detachment, But Both Are Severe And Life-Threatening Drug Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) Stevens-Johnson syndrome (SJS) was first described in 1922, and toxic epidermal necrolysis (TEN) was first described in 1956...

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