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The Drug Injury Watch Blog  (Visit Our New Site >>)

List Of Most Recent Posts With Summary And Link To Original Article

On his Drug Injury Watch blog site attorney Tom Lamb provides up-to-date news and information from the legal, medical, FDA, and pharmaceutical sectors. His blog posts add insight from a drug litigation lawyer perspective, but are written to be read by patients and consumers.


Antidepressant-Related Birth Defect: Heart And Lung Disorder PPHN - Persistent Pulmonary Hypertension Of The Newborn


Increased Risk Of PPHN When Women Use SSRIs Medications Like Celexa, Lexapro, Paxil, Prozac, And Zoloft After Their 20th Week Of Pregnancy

SUMMARY: Persistent pulmonary hypertension of the newborn (PPHN) is a serious but often overlooked drug risk presented by some popular antidepressant drugs like Celexa, Lexapro, Paxil, Prozac, and Zoloft. These prescription medications are in the Selective Serotonin Reuptake Inhibitors, or SSRIs, class of drugs.

While the FDA has looked at this drug safety problem for some years, now, unfortunately the agency has not reached any definitive conclusions and certainly has not taken the necessary actions to prevent future cases of PPHN caused by antidepressants / SSRIs like Celexa, Lexapro, Paxil, Prozac, and Zoloft, despite the severity of this birth defect condition.

Likewise, the drug companies responsible for these widely used antidepressants have apparently not taken the obvious steps to heighten awareness of the SSRI - PPHN drug safety issue by getting Prozac, for example, moved to Pregnancy Category D (Prescription drugs which are known to impose health risks for the fetus).

[Read this article in full at original source]

 


Benicar-Induced Enteropathy: Recently Found / New Possible Cause Of Villous Atrophy: Symptoms And Diagnosis

Chronic Or Severe Diarrhea With Damage To The Intestinal Villi And Malabsorption Indicate Sprue-Like Enteropathy

SUMMARY: An article from the January 2014 edition of the Pharmacy and Therapeutics (P&T®) medical journal includes an article, "Olmesartan and Drug-Induced Enteropathy" (PDF format), which provides some valuable information concerning the symptoms and diagnosis of this recently found Benicar side effect.

Patients taking Benicar should be aware of the various symptoms that may be related to sprue-like enteropathy and, if those occur, report them to the prescribing doctor or one of their other physicians.

Meanwhile, some Benicar drug injury lawsuits have been filed against the drug company Daiichi Sankyo for their alleged failure to adequately or timely warn doctors and patients about the apparent link between Benicar and sprue-like enteropathy.

[Read this article in full at original source]



More Evidence Supporting A Link Between Testosterone Therapy And Higher Risk Of Cardiovascular-Related Events Such As Myocardial Infarctions Or Heart Attacks

For "Low-T" Drugs Like AndroGel, Axiron, And Testim, Serious Side Effects Are Increased With Age -- Highest Risks In Men Over 65 And For Men With Pre-Existing Diagnosed Heart Disease

SUMMARY: The take-away points from this PLoS ONE article about the association between testosterone therapy medications, e.g., AndroGel, Axiron, Testim, and non-fatal myocardial infarctions (MI), or heart attacks, seem to be two:

(1) The risk of having non-fatal MI or heart attack following the start of a testosterone therapy prescription increases with age, and was substantially increased in older men; and,

(2) This cardiovascular-related risk was also substantially increased in younger men with pre-existing diagnosed heart disease.

Be assured that we are continuing to monitor this emerging drug safety issue concerning testosterone drugs like AndroGel, Axiron, and Testim.

[Read this article in full at original source]

 


The Growing Use Of Testosterone Creams, Gels, Injections, And Patches Raises Increased Concerns About Risks Of Cardiac Side Effects

Critics Of "Low-T" Drugs Like Axiron, AndroGel, And Testim Blame Medically Unnecessary Use Of Androgen Therapy On Drug Company Advertising

SUMMARY: How does one explain the fact that the number of middle-aged men in the U.S. getting testosterone treatments has more than tripled over the last decade? Another question: How have these "Low-T" drugs become so popular while so little is known about their long-term safety?

At least according to one study, this may be due to advertising campaigns for testosterone products that are arguably aimed men who do not have clinically low testosterone levels, i.e., had not undergone a blood test to see if they really needed Testosterone replacement therapy (TRT), also called androgen replacement therapy (ART).

Those men who use these testosterone drugs like Axiron, AndroGel, and Testim may want to see our recent article: "Increasingly Popular Testosterone Replacement Therapy Drugs Are Linked To Myocardial Infarctions Or Heart Attacks, Strokes, And Deaths".

[Read this article in full at original source]

 


Increasingly Popular Testosterone Replacement Therapy Drugs Are Linked To Myocardial Infarctions Or Heart Attacks, Strokes, And Deaths


Medical Studies Show An Increased Risk Of Cardiovascular Events In Older Men Prescribed Testosterone Medications Such As Axiron, AndroGel, And Testim

SUMMARY: While it is estimated that the number of middle-aged men in the U.S. getting testosterone treatment has more than tripled over the last decade, the long-term risks are largely unknown.

Some of the prescription testosterone drug products approved by the FDA and available for use to treat low testosterone, or "Low T" syndrome, include:

•AndroGel
•Axiron
•Testim

Men with certain cardiac conditions such as heart disease who are prescribed these testosterone replacement therapy medications face an increased risk of cardiovascular adverse events according to recent medical journal article.

[Read this article in full at original source]

 


FDA Drug Safety Concerns About Pradaxa And Serious Bleeding Side Effects Will Get Another Look By Means Of New 2014 Study


A Primary Focus Is Gastrointestinal And Intracranial Hemorrhages In Patients Using Pradaxa For Atrial Fibrillation

SUMMARY: On December 30, 2013 the FDA posted for public comment on a proposed protocol of a new study intended to be a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of Pradaxa (dabigatran) or Coumadin (warfarin).

Some background information about this Pradaxa FDA study of can be found in a January 3, 2014 Forbes article by Larry Husten, "FDA Plans New Safety Assessment Of Dabigatran (Pradaxa)".

We will be watching the FDA and the medical news reports for future developments concerning this latest FDA safety review regarding Pradaxa and serious bleeding side effects, some of which can result in death.

[Read this article in full at original source]

 


The Association Of Antipsychotic Drug Risperdal (Risperidone) With Gynecomastia / Male Breasts Side Effect Is Subject Of Pharmaceutical Litigation Against Janssen

Legal Issue In These Risperdal Lawsuits Is Whether The Drug Label Provided Timely And Sufficient Warning About The Development Of Breasts In Boys And Men

SUMMARY: From a relatively quick review of the medical literature we could find that the association between Janssen Pharmaceuticals antipsychotic drug Risperdal and the development of breasts in boys or men, i.e., gynecomastia, has been known for some years now.

As regards drug-induced gynecomastia, i.e., the development of breasts in men and boys, the current Prescribing Information, or package insert, for Risperdal (accessed 1/9/2014) has rather limited information under the WARNINGS AND PRECAUTIONS at section 5.6 which is titled "Hyperprolactinemia".

[Read this article in full at original source]

 


Pfizer's Lipitor Statin Drug For Treatment Of High Cholesterol Linked To An Increased Risk Of Type-2 Diabetes In Some Older And Post-Menopausal Women

February 2012 FDA Drug Safety Warning About Lipitor Label Change Concerning New-Onset Diabetes Mellitus (DM) Has Gone Largely Unnoticed To Date

SUMMARY: From the February 28, 2012 "FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drug":

Based on clinical trial meta-analyses and epidemiological data from the published literature, information concerning an effect of statins on incident diabetes and increases in HbA1c and/or fasting plasma glucose was added to statin labels.

And from the final paragraph of this January 2012 medical journal article, "Statin use and risk of diabetes mellitus in postmenopausal women in the Women's Health Initiative", we get this point: "However, the consequences of statin-induced DM have not been specifically defined and deserve more attention." [emphasis added]

We will continue to watch this still-emerging drug safety issue concerning diabetes and Lipitor, as well as other statin cholesterol drugs.

[Read this article in full at original source]

 


September 2013 NuvaRing Update By Merck Reveals More Than 1,700 Lawsuits Filed Since This Products Liability Litigation Started In 2007


Serious Injury And Death Cases Involve Blood Clots Leading To DVT And/Or PE Events As Well As Heart Attacks And Strokes In Women Of Various Age

SUMMARY: The Form 10-Q SEC filing by Merck for the corporate quarterly period ending September 30, 2013 (93 page PDF document) provides us with this latest information about the number of filed NuvaRing lawsuits: "As of September 30, 2013, there were approximately 1,715 NuvaRing cases."

In comparison, at the end of June 2013 there were approximately 1,500 NuvaRing cases.

My law firm has been involved with the NuvaRing litigation since it started in 2007. We will continue to monitor the NuvaRing litigation and report significant developments as they become publicly available.

[Read this article in full at original source]

 


During 2013 Bayer Has Had More Than 2000 YAZ / Yasmin Lawsuits For Blood Clots That Are Not Settled

September 2013 Bayer Corporate Report Shows Apparent Progress In Settlement Negotiations, But A Number Of More Serious Cases Are Still Pending

SUMMARY: From the Bayer Stockholders’ Newsletter, Financial Report as of September 30, 2013, Third quarter of 2013:

As of October 18, 2013, Bayer had reached agreements, without admission of liability, to settle the claims of approximately 7,660 claimants in the U.S. for a total amount of about US$1.575 billion. Bayer has only been settling claims in the U.S.for venous clot injuries (deep vein thrombosis or pulmonary embolism).... Such injuries are alleged by about 2,300 of the pending unsettled claimants. Bayer will continue to consider the option of settling such individual lawsuits in the U.S. on a case-by-case basis.

It remains to be seen whether there will be any court trials for YAZ, Yasmin, Ocella, Gianvi, Beyaz, and Safyral lawsuits involving arterial clots, which can cause strokes and other serious side effects. Reportedly, thus far the lawyers for Bayer have refused to negotiate these types of cases.

[Read this article in full at original source]

 


Merck Faces More Than 4100 Fosamax - Femur Fracture Lawsuits As Of September 30, 2013 According To SEC Corporate Filing

Next Bellwether Trial Dates: In New Jersey, One To Three Cases Set For March 2014; And, In Fosamax Federal Court MDL, One Case Set For May 2014

SUMMARY: From the Merck SEC Form 10-Q for the quarterly period ended September 30, 2013:

•... plaintiffs in approximately 4,115 of these actions generally allege that they sustained femur fractures and/or other bone injuries (“Femur Fractures”) in association with the use of Fosamax.
•... approximately 1,085 cases were pending in the Fosamax Femur Fracture MDL as of September 30, 2013.
•As of September 30, 2013, approximately 2,520 cases alleging Femur Fractures have been filed in New Jersey state court and are pending before Judge Higbee in Atlantic County Superior Court.

We will continue to monitor the Fosamax - femur fracture litigation and report significant developments.

[Read this article in full at original source]

 


The Pradaxa Gastrointestinal (GI) Bleeding Debate Continues: Is There An Increased Risk Or A Risk Reduction With Pradaxa Use?


A Medical Journal Article About New Meta-Analysis Of Four Pradaxa Trials Shows More GI Bleeds With "New" Blood Thinner Pradaxa Vs. "Old" Warfarin Treatment

SUMMARY: We continue to monitor the medical journals for developments as regards the association between Pradaxa and gastrointestinal (GI) bleeding events, some of which have caused patient deaths.

A report published online in November 2013 by the medical journal JAMA: Internal Medicine, "A comparison of results of the US Food and Drug Administration's Mini-Sentinel Program with randomized clinical trials: The case of gastrointestinal tract bleeding with dabigatran", raises more drug-safety issues for the still relatively new blood thinner Pradaxa, from Boehringer Ingelheim Pharmaceuticals.

[Read this article in full at original source]

 


Flomax Can Cause Severe Hypotension According To A New Medical Study Article Published In November 2013 BMJ Journal


Low Blood Pressure Can Lead To Loss Of Consciousness / Fainting With A Fall Down Resulting In Injury And Hospital Admission

SUMMARY: Despite being on the US market for more than 15 years, it has been unknown whether Flomax, a selective α1a receptor antagonist, increases the risk of hypotension --abnormally low pressure of the blood, commonly called "low blood pressure" -- needing a hospital admission.

A new study suggests, however, that during the eight-weeks period after Flomax was first started and the eight weeks after a patient restarted Flomax treatment, there is a roughly doubled risk for hypotension needing hospital admission.

We agree with this idea from the study authors: Doctors should warn patients regarding the apparent association between Flomax and severe hypotension events, some of which may lead to a patient falling down and requiring hospitalization for treatment.

[Read this article in full at original source]

 


October 2013 NuvaRing Label Change: Warnings And Precautions Section Sets Forth Two Competing Medical Studies About Side Effects

In Addition, The New Package Insert No Longer States It Is Unknown If NuvaRing Has A Different Blood Clot (VTE) Risk Than Some Birth Control Pills

SUMMARY: In October 2013 the FDA approved some revisions to the NuvaRing label that can be found in the "Warnings and Precautions" section, specifically at this part, "Thromboembolic Disorders and Other Vascular Problems".

The two competing medical studies are:

•  1. Dinger, J et. al., Cardiovascular risk associated with the use of an etonogestrel-containing vaginal ring. Obstetrics & Gynecology 2013; 122(4): 800-808.
•  2. Sidney, S. et. al., Recent combined hormonal contraceptives (CHCs) and the risk of thromboembolism and other cardiovascular events in new users. Contraception 2013; 87: 93–100.

We will continue to monitor the safety profile of NuvaRing as well as the related products liability litigation involving more than 1500 personal injury and wrongful death cases.

[Read this article in full at original source]

 


Is Plavix-Related Hemophilia Side Effect Significant Enough For Label Change In Europe But Not In U.S.

Sanofi Has Sent Out "Dear Doctor" Letters About The Association Of Plavix (Clopidogrel) Acquired Hemophilia There -- Why Not Here, Too

SUMMARY: This Sanofi "Direct Healthcare Professional Communication on the association of clopidogrel with acquired haemophilia" which was issued in Ireland is dated August 23, 2013.

In reviewing the current Bristol-Myers Squibb/Sanofi Pharmaceuticals Plavix Prescribing Information (Revised September 2013) found on the FDA's website (accessed 10/30/13), however, there is no mention of hemophilia in that document.

Perhaps a revised Plavix label is awaiting FDA approval, or maybe Bristol-Myers and Sanofi are not going to add any hemophilia warning here in the U.S.


[Read this article in full at original source]

 


Pradaxa Adverse Drug Events (ADEs) Result In Death More Often Than Other Anticoagululants / Blood Thinners ADE Reports
 

Again In 2012, Pradaxa (Dabigatran) Had Dubious Distinction Of Being Ranked First For Direct FDA Reports Of Adverse Events  

SUMMARY: As regards Pradaxa, we get this disturbing fact from the October 2013 edition of ISMP QuarterWatch, Data from 2012 Quarter 4 and Annual Report:  

As in our previous analysis, reported [Pradaxa (dabigatran)] adverse event cases were more likely to result in death, accounting for 18% of cases, compared to 6.5% deaths for warfarin and 7.2% for rivaroxaban.  

And the October 2013 QuarterWatch article points out this rather strange FDA action as regards Pradaxa:  

In April 2013, the FDA required an unusual Boxed Warning -- normally an alert to a dire drug risk -- stating that stopping the drug might increase the risk of stroke, but neglecting to mention that stopping [Pradaxa (dabigatran)] would also reduce the risk of severe hemorrhage.  

We will continue to monitor the safety profile of Pradaxa.  

[Read this article in full at original source]

 

 


  • US FDA advises that you should not stop taking any prescription medication before talking to your doctor.
  • Reports of serious drug side effects should be made to the US FDA MedWatch program.
  • The prescription drug names are registered trademarks of the respective drug companies.
  • DrugInjuryLaw.com is not affiliated with any of the drug companies, nor US FDA.