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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Monthly Archives: April 2014

2012 – Doctor Explains Link Between Finasteride (Proscar, Propecia) and Sexual Side-Effects

Posted in Propecia / Proscar

In early 2012, before the Propecia and Proscar Warning Labels were changed to include more information about sexaul side effects, a study published by Venkataram Mysore in Indian Dermatology Online Journal titled “Finasteride and sexual side effects” aimed to further clarify the relationship between finasteride (the active chemical in the the two aforementioned drugs) and… Continue Reading

2007 – High Rates of Sexual Side-Effects with Proscar, Propecia

Posted in Propecia / Proscar

A 2007 article by N. Mondaini et al. titled “Finasteride 5 mg and sexual side effects: how many of these are related to a nocebo phenomenon?” published in Journal of Sexual Medicine provides important insight into the connection between finasteride (the active chemical in the hair loss drug Propecia and the benign prostatic hyperplasia (BPH)… Continue Reading

2003 – Propecia, Proscar linked to long-term sexual side-effects

Posted in Propecia / Proscar

In 2003, an article published in International Journal of Impotence Research by D.J. Carbone Jr. et al. titled “Medical therapy for benign prostatic hyperplasia: sexual dysfunction and impact on quality of life.” aimed to clarify the link between use of finasteride, the active ingredient in hair loss drug Propecia and benign prostatic hyperplasia (BPH) drug… Continue Reading

2014 – American Journal of Cardiology: Statins increase risk for diabetes

Posted in Lipitor

Recently, an article published in The American Journal of Cardiology titled “Risk of new-onset diabetes mellitus versus reduction in cardiovascular events with statin therapy.” provided important insight into the connection between statin drugs (Lipitor, Crestor, others) and new-onset diabetes. KL Wang et al. (2014) write “The Food and Drug Administration recently updated the safety warning… Continue Reading

2011 – Doctors investigate link between Lipitor and diabetes

Posted in Lipitor

An article appearing in the July, 2011 issue of Current Opinion in Cardiology titled “Are statins diabetogenic?” by U.K. Sampson et al. gives us a bit more information on the connection between drugs like Lipitor and new-onset diabetes. The team writes “Statins are widely utilized for low-density lipoprotein lowering and for prevention of atherosclerotic cardiovascular… Continue Reading

2014 – Twice as many statin users develop diabetes after liver transplant

Posted in Lipitor

Published in the January, 2014 edition of the medical journal Liver Transplantation by Y. Cho et al., an article titled “Statin therapy is associated with the development of new-onset diabetes after transplantation in liver recipients with high fasting plasma glucose levels.”  provides further insight into the connection between statin therapy and new-onset diabetes.  For clarity,… Continue Reading

2014 – Statins raise risk for diabetes by 9% to 43%

Posted in Lipitor

In 2014, an article published by Kwok Leung Ong et al. titled “Cardiovascular drugs that increase the risk of new-onset diabetes” in Curriculum in Cardiology aimed to further elucidate the connection between statin drugs and new-onset diabetes.  Statin drugs are a popular type of cholesterol-lowering medications including Lipitor, Crestor, Zocor, and many others.  Other classes… Continue Reading

2011 – Lipitor, other statins linked to increased risk for diabetes

Posted in Lipitor

Published in a 2011 edition of Atherosclerosis, a study titled “Differential metabolic effects of distinct statins.” by K.K. Koh et al. aimed to determine how statin drugs affect the body.  Statins are a class of cholesterol-lowering drugs including Lipitor, Crestor, Zocor, and others. These researchers write “Reciprocal relationships between endothelial dysfunction and insulin resistance suggest… Continue Reading

2010 – Four times as many adverse cardiac events in AndroGel users vs. placebo

Posted in Androgel

In 2010, a study was published in The New England Journal of Medicine titled “Adverse events associated with testosterone administration.” by S. Basaria and a team of researchers, aiming to further clarify adverse events associated with testosterone therapy.  Currently, testosterone therapy is provided in the treatment of “Low-T” and other ailments, many in the medical… Continue Reading

2013 – Independent studies show two-fold increased risk for adverse cardiac events with testosterone therapy

Posted in Androgel

In the April, 2013 edition of BMC Medicine, L. Xu et al. published the results of a study titled “Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials.”.  This study sought to assess the relative safety of testosterone therapy with respect to adverse cardiac events.  The research team… Continue Reading

Proposed Class-Action Lawsuit Filed Against Manufacturer & Distributor of OxyElite Pro

Posted in FDA Regulation, Lawsuits, Safety Alerts

A man by the name of Sandeep Barot has filed a proposed consumer protection class-action lawsuit against the manufacturer and distributor of dietary supplements that allegedly cause liver damage. See Barot v. USPLabs LLC et al., No. 1:14-cv-00562, complaint filed (D.N.J. Feb. 3, 2014). The defendant companies are USPLabs, LLC (“USPLabs”) and General Nutrition Center… Continue Reading

2012 – “Bladder cancer is a real risk with [Actos]”

Posted in Actos & Bladder Cancer

A recent article published as an editorial in Diabetes Research and Clinical Practice by JA Johnson et al. titled “Balancing the risks and benefits for pioglitazone in type 2 diabetes.” set out to clarify some of the risks and benefits of using the diabetes drug Actos (pioglitazone). The authors state “All therapeutic choices need to… Continue Reading

2012 – Long-term Actos use raises risk for bladder cancer 60-80%

Posted in Actos & Bladder Cancer

In 2012, an article was published in Urology titled “Association between pioglitazone and urothelial bladder cancer.” by Y. Barbalat et al. that aimed to “present the current literature reporting the association between pioglitazone and bladder cancer.”  To be clear, “pioglitazone” is the chemical name for the diabetes drug, Actos, manufactured by Takeda Pharmaceutical Co. and… Continue Reading

2013 – Actos associated with 56% increased risk for bladder cancer

Posted in Actos & Bladder Cancer

A recent article published in the August, 2013 edition of Hepatology by CH Chang et al. titled “Association of thiazolidinediones with liver cancer and colorectal cancer in type 2 diabetes mellitus” studied the connection between certain diabetes drugs and cancer.  Thiazolidinediones are a class of diabetes drugs including Actos and others. This team of researchers… Continue Reading

Actos Manufacturers Slated to Pay $9 Billion in Damages

Posted in Actos & Bladder Cancer

Recently, a federal court has ordered that the manufacturers of the diabetes drug Actos (pioglitazone hydrochloride, by Takeda Pharmaceutical Co. and Eli Lilly & Co.) pay $9 billion in damages when it was determined that these companies failed to warn the public of cancer risks associated with their medication. Though some legal experts believe that… Continue Reading

2014 – Diabetes risk raised 30% by Lipitor use

Posted in Lipitor

Published March, 2014 in BMC Medicine, a report by AF Macedo et al. titled “Unintended effects of statins from observational studies in the general population: systematic review and meta-analysis.” aimed to “assess unintended effects of statins from observational studies in general populations with comparison of the findings where possible with those derived from randomized trials.”… Continue Reading

2014 – Scientists work on mechanism linking Lipitor and diabetes

Posted in Lipitor

In February, 2014, an article titled “Statin treatment and new-onset diabetes: A review of proposed mechanisms.” appearing in the medical journal Metabolism discusses the role of statin use in new onset diabetes.  Statin drugs are cholesterol-lowering medications including Lipitor, and are among the most widely-prescribed drugs in the world. This research team, led by M…. Continue Reading

2014 – Body Type, Lipitor Use are Risk Factors for Diabetes

Posted in Lipitor

An article published in the March, 2014 edition of The American Journal of Cardiology titled “Effect of Change in Body Weight on Incident Diabetes Mellitus in Patients With Stable Coronary Artery Disease Treated With Atorvastatin (from the Treating to New Targets Study).” by KL Ong et al. aimed to further clarify the link between Lipitor… Continue Reading

2014 – Lipitor use linked to diabetes, study shows

Posted in Lipitor

A recent article published by M. Ruscica et al in European Journal of Internal Medicine titled “Statin therapy and related risk of new-onset type 2 diabetes mellitus.” provides unique insight into the connection between the use of statin drugs and new onset diabetes.  For clarity, statin drugs are a class of cholesterol-lowering medications including Lipitor,… Continue Reading

Investigation Launched into Whether Johnson & Johnson Obstructed Justice and Tampered with Evidence by Deliberately Destroying Records

Posted in Vaginal Mesh

Johnson & Johnson (J&J) executives are currently under the microscope as to whether or not they engaged in criminal activity when they “lost” documents critical to lawsuits filed against them. As we noted in previous posts, on February 4th, a federal magistrate judge ruled that Ethicon, a subsidiary of J&J, destroyed or lost documents that… Continue Reading

Our Comment in Support of the FDA’s Proposed Rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985)

Posted in Generic Drugs, Preemption

Janice L. Weiner Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave. Bldg. 51, Room 6304 Silver Spring, MD 20993-0002   Dear Ms. Weiner, We are grateful for the opportunity to submit comments in support of the Food and Drug Administration’s (FDA) proposed rule entitled, Supplemental Applications Proposing Labeling Changes… Continue Reading