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Dangerous Drugs & Medical Devices

News & Commentary on Prescription Drug & Medical Device Lawsuits

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 field believe that testosterone is overprescribed.  Further, studies have shown that testosterone is associated with an increased risk for cardiac arrest, stroke, and death, especially in older men.

Studying a group of men older than 65 with low testosterone, Basaria administered either a placebo topical “testosterone” gel or real testosterone topical gel such as Androgel to this cohort, and closely observed the group for six months.

At the end of the observation period, 209 men remained in the study.  The research team writes “During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events”, findings consistent with the results of other studies on the association between adverse cardiac events and testosterone therapy, but from an admittedly small sample size.

As such, the team writes “In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy.”

However, the manufacturers of AndroGel (AbbVie, Inc., Abbott Laboratories, Inc.), a popular topical testosterone gel, have failed time and again to warn users of this risk.  As a result, a number of AndroGel testosterone lawsuits are currently being filed.  If you or a loved one used AndroGel and suffered an adverse cardiac event, stroke, or death as a result, you may be entitled to significant financial compensation.

For a free, no-obligation case consultation, contact our team of AndroGel lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our AndroGel Lawsuit Information page is a great place to start if you have any questions about AndroGel.

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 writes “Testosterone therapy is increasingly promoted” and notes “No randomized placebo-controlled trial has been implemented to assess the effect of testosterone therapy on cardiovascular events, although very high levels of androgens are thought to promote cardiovascular disease.”

To perform this meta-analysis, Xu et al. (2013) reviewed previously-published randomized controlled studies involving testosterone administration and used statistics to normalize the results.  “Of 1,882 studies identified 27 trials were eligible including 2,994, mainly older, men who experienced 180 cardiovascular-related events.”  Overall, results showed that “Testosterone therapy increased the risk of a cardiovascular-related event” by 54%.

Importantly, this study also revealed that “In trials not funded by the pharmaceutical industry the risk of a cardiovascular-related event on testosterone therapy was greater (OR 2.06, 95% CI 1.34 to 3.17) than in pharmaceutical industry funded trials (OR 0.89, 95% CI 0.50 to 1.60).”

This means that studies funded by the pharmaceutical industry found testosterone therapy to have no connection with adverse cardiac events, while independent studies found testosterone therapy more than doubles the risk for adverse cardiac events.

Due to the fact that the manufacturers of testosterone therapy products such as AndroGel, a popular topical testosterone gel, have failed time and again to warn users of the risk for cardiac arrest, stroke, and death associated with AndroGel, a number of AndroGel lawsuits have been filed.  If you or a loved one used AndroGel and suffered one of these side effects, you may be entitled to significant financial compensation for your injury.  For a free, no-obligation case consultation, contact our team of AndroGel lawyers at the information provided below.  We have the experience, resources, and skills required to win the compensation you deserve.

Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our AndroGel Lawsuit Information page is a great place to start if you have any questions about AndroGel.

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 Holdings Inc. (“GNC”). USPLabs sells a variety of energy and weight loss dietary supplements under the brand name of OxyElite Pro through GNC.

The complaint was filed in the U.S. District Court for the District of New Jersey. In it, Plaintiff Barot says he bought and used OxyElite Pro supplements while living in New Jersey between March 2010 and October 2011. He says he bought the product at a GNC store. Barot says OxyElite Pro was sold in New Jersey between January 2008 and November 2013.

In April 2012, the Food and Drug Administration warned USPLabs about the use of a dangerous stimulant called dimethylamylamine (“DMMA”) in its products. A class-action complaint followed and was resolved by a settlement agreement. Hogan v. USPLabs LLC, No. BC486925 (Cal. Super. Ct., L.A. County).

However, during and subsequent to Hogan v. USPLabs, LLC, Defendant USPLabs contained and or included another dangerous ingredient in OxyElite Pro called, Aegeline. Public health officials are currently investigating severe illnesses allegedly connected to Aegeline, including liver disease and hepatitis.

Plaintiff Barot points to medical records submitted to the FDA by the Hawaii Department of Health in which patients who used OxyElite Pro became severely ill. The complaint states that the use of the product was the only common factor among the patients and many became well again after stopping its use. Therefore, the complaint argues, the likelihood that OxyElite Pro caused the illnesses is strong.

While some consumers were lucky enough to get well after they ceased ingesting the dietary supplement, for others, the damage had already been done. Several patients sustained liver injuries that required transplantation. Tragically, one patient died before a transplant could be performed. As of February, OxyElite Pro has been linked to 97 cases of hepatitis.

On Oct. 11, 2013, the FDA issued a warning to USPLabs to stop distribution of all products containing aegeline. The company conducted a voluntary recall about one month later, but Barot says it failed to provide any notice to consumers.

The complaint alleges violations of the New Jersey Consumer Fraud Act, N.J. Stat. Ann. § 56:8-1; breach of implied warranty; unjust enrichment; and violation of the Magnuson-Moss Warranty Act, 15 U.S.C. § 2301.

Specifically, Barot says he and other potential class members suffered economic damage in buying USPLabs’ products, which they would not have taken had they known of aegeline’s potential adverse effects. He also alleges that inadequate labeling on the product constituted an unfair trade practice because the ingredients were unfit for safe use and that the defendant companies were unjustly enriched at the expense of consumers’ health.

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 be based on the balance of potential risks and benefits. Treatment decisions are not always easy, and are best achieved when considering all available evidence. Busy clinicians may be aided in this process by syntheses of the evidence, particularly when it is rapidly evolving. A case in point is the role glucose-lowering therapies may play in modulating the elevated risk of many cancers in patients with type 2 diabetes mellitus. In this issue of Diabetes Research and Clinical Practice, Zhu et al. 1 contribute a meta-analysis of the use of pioglitazone and the risk of bladder cancer, synthesizing data from 5 previously published studies and almost 2.4 million people. From these data, they report that pioglitazone use is associated with an overall 17% increased risk of bladder cancer. The authors also summarized findings of greater risks with larger cumulative doses and longer duration of pioglitazone use, which strengthen an inference of causality for this association.”

Though Johnson et al. (2012) point out a few limitations of the above-described Zhu et al. study, the team writes “Regardless of methodologic differences, however, our conclusions are consistent, that exposure to pioglitazone is associated with an increased risk of bladder cancer in people with type 2 diabetes, compared to not being exposed to pioglitazone. This finding is further corroborated by a meta-analysis of randomized controlled trials on file with the manufacturer 3.”

They continue “With the strong and consistent evidence, including preclinical animal studies, synthesis of data from [randomized control trials] and observational studies, and demonstration of a dose-risk gradient, it seems very likely that bladder cancer is a real risk with pioglitazone for patients with type 2 diabetes. This risk is likely in the range of a 20–25% relative increase, which may be even greater with longer term use.”

Due to the fact that Takeda Pharmaceutical Co. and Eli Lilly & Co., the manufacturers of Actos, have failed time and again to notify users of the risk for bladder cancer associated with their medication, a number of Actos bladder cancer lawsuits have been filed.  If you or a loved one used Actos and suffered bladder cancer, you too may be entitled to significant financial compensation.

For a free, no-obligation case consultation, contact our team of Actos bladder cancer lawyers at the information provided below.  We have the compassion, resources, and experience required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

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 Eli Lilly & Co.

The team writes “The U.S. Food and Drug Administration (FDA) has recently informed the public that the use of pioglitazone may be associated with an increased risk of bladder cancer. 3 The European Medicines Agency (EMA) released a similar statement 4 and some European countries, such as France and Germany, have already removed pioglitazone from the market. Clearly, this association has many implications from an oncologic and clinical standpoint.”

One study the team cites was conducted by Suzuki et al., finding “pioglitazone produced calcium-containing urinary solids, which were associated with increased urothelial cytotoxicity, necrosis, and regenerative proliferation.”  Another study cited found “pioglitazone is a PPARγ ligand used in the treatment of DMII and was found to have carcinogenic activity toward the male rat bladder.”

Concerning human subjects trials, the paper notes first a study evaluating 5,238 patients receiving Actos that found “trend toward more bladder tumors” but failed to reach statistical significance.  Another study evaluating over 30 thousand Actos users of 193 thousand members of a particular health insurance plan found “Among men only, there was a significant increase in the relative hazard of bladder cancer with >24 months of exposure (HR 1.6; 95% CI 1.2-2.3) and with a >28,000 mg cumulative dose (HR 1.8; 95% CI 1.2-2.6).”  That means that in men who used Actos for longer than two years, the risk for bladder cancer was raised by 60%, and in men who took more than 28,000 mg of Actos over time, the risk for bladder cancer was raised by 80%, nearly double the risk for bladder cancer compared with non-users.

Overall, and thankfully, the team notes that “Ninety-five percent of cancers diagnosed among pioglitazone users were detected at an early stage” and comments that “the health benefits of pioglitazone may outweigh the risk of bladder cancer associated with this drug. Nevertheless, urologists should be aware of this possible risk, especially when managing diabetic patients with hematuria or other risk factors for bladder cancer.”

Due to the fact that a number of people have used Actos unaware of the connection the drug has with bladder cancer, a number of Actos bladder cancer lawsuits have been filed.  If you or a loved one used Actos and suffered bladder cancer as a result, you too may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Actos lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

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 wrote “The objective of this nationwide case-control study was to evaluate the risk of specific malignancy in diabetic patients who received thiazolidinediones (TZDs)” and studied a total of 606,583 patients with type II diabetes without a history of cancer.

“A total of 10,741 liver cancer cases, 7,200 colorectal cancer cases, and 70,559 diabetic controls were included. A significantly lower risk of liver cancer incidence was found for any use of rosiglitazone (OR: 0.73, 95% CI: 0.65-0.81) or pioglitazone (OR: 0.83, 95% CI: 0.72-0.95), respectively.”  This means that Actos (pioglitazone) was associated with a lower risk for liver cancer, and so was Avandia (rosiglitazone).

However, the team found that “a potential increased risk for bladder cancer with pioglitazone use 3 years could not be excluded (OR: 1.56; 95% CI: 0.51-4.74),” meaning that Actos was associated with a 56% increased risk for bladder cancer.

Due to the fact that a number of people have used Actos unaware of the risk for bladder cancer, a number of Actos bladder cancer lawsuits have been filed.  If you or a loved one used Actos and suffered bladder cancer, contact our team of Actos bladder cancer lawyers for a free consultation at the information provided below.  You and your family may be entitled to significant financial compensation, and we have the experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

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 this penalty will be lowered by appellate courts, this federal decision marks a turning point in a years-long struggle for compensation for damages caused by Actos.  (Reuters notes that “The $9 billion in punitive damages awarded by the jury against Takeda and Eli Lilly exceed the $5 billion penalty that a jury in Alaska imposed on Exxon Mobil Corp for the Exxon Valdez oil spill in 1989.”)

For years, law firms around the country have been signing up clients injured by Actos to secure compensation from a settlement such as this, and it seems that day has come a bit closer.

Unfortunately, Actos manufacturers continued producing the drug in light of a huge number of scientific studies connecting Actos to cancer and liver damage without warning patients, and as such, the number of patients injured by the drug has likely increased rather than decreased while the scientific community concluded the drug is unacceptably dangerous.

Here are a few studies I’ve summarized linking Actos and bladder cancer:

Large Study Shows Actos Raises Risk for Bladder Cancer 30%

Actos Shown to Increase Risk for Bladder Cancer

FDA: Actos Raises Risk for Bladder Cancer by 430%

Long-term Actos Use Doubles Risk for Bladder Cancer

 

If you or a loved one used Actos and suffered bladder cancer as a result, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Actos bladder cancer lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

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.”

Statins are class of medications prescribed to treat high cholesterol and have a reliable track record for reducing the risk of adverse cardiovascular events.  Unfortunately, the drugs (such as Lipitor, Zocor, Crestor, and others) have been linked to a 10-30% increased risk for new onset diabetes, another disease affecting millions around the world.

Evaluating 90 different studies of statin side effects, this team determined that “There was evidence of an increased risk of myopathy, raised liver enzymes and diabetes (respectively: OR 2.63 (95% CI 1.50 to 4.61); OR 1.54 (95% CI 1.47 to 1.62); OR 1.31 (95% CI 0.99 to 1.73)).”  In non-scientific terms, this means that statin use raised the risk for myopathy by 163%, raised liver enzymes 54%, and diabetes by 31%.

Sadly, the manufacturer of Lipitor and other statin drugs has failed time and again to warn users of the risks associated with their medication.  As a result, a number of Lipitor lawsuits have been filed.  If you or a loved one used Lipitor and suffered diabetes as a result, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Lipitor lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Lipitor Lawsuit Information page is a great place to start if you have any questions about Lipitor.

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. Brault states that “New-onset diabetes has been observed in clinical trials and meta-analyses involving statin therapy.”  In an attempt to elucidate the biochemical mechanism by which statin use contributes to diabetes onset, the team suggests that “First, certain statins affect insulin secretion through direct, indirect or combined effects on calcium channels in pancreatic β-cells. Second, reduced translocation of glucose transporter 4 in response to treatment results in hyperglycemia and hyperinsulinemia. Third, statin therapy decreases other important downstream products, such as coenzyme Q10, farnesyl pyrophosphate, geranylgeranyl pyrophosphate, and dolichol; their depletion leads to reduced intracellular signaling. Other possible mechanisms implicated in the effect of statins on new-onset diabetes are: statin interference with intracellular insulin signal transduction pathways via inhibition of necessary phosphorylation events and reduction of small GTPase action; inhibition of adipocyte differentiation leading to decreased peroxisome proliferator activated receptor gamma and CCAAT/enhancer-binding protein which are important pathways for glucose homeostasis; decreased leptin causing inhibition of β-cells proliferation and insulin secretion; and diminished adiponectin levels.”

Of course, Brault et al. (2014) are cautious to write-off statin use with the increased risk for diabetes posed considering the dramatic benefit these drugs have in relation to heart disease and cholesterol level adjustment and maintenance.  Sadly, however, a number of people have used Lipitor and other similar drugs unaware of the risk for diabetes due to a failure to warn on the part of the manufacturer.  Every patient deserves to know all possible risks and benefits associated with any drug ingested.

As a result of this failure to warn, a number of Lipitor diabetes lawsuits have been filed.  If you or a loved one used Lipitor and suffered diabetes as a result, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Lipitor lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Lipitor Lawsuit Information page is a great place to start if you have any questions about Lipitor.

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 use and new onset diabetes.

While Lipitor and other drugs in the statin class are highly effective in reducing the risk for adverse cardiac events, a great deal of research has come out linking Lipitor and diabetes, a risk of which patients should at the very least be aware.

This research team “investigated whether change in body weight may predict NODM in statin-treated patients” and “7,595 patients without prevalent diabetes mellitus at baseline from the Treating to New Targets (TNT) study were included in this analysis.”  After a great deal of statistical analysis, the team concluded that “1-year change in body weight is predictive of NODM in patients who underwent statin therapy from the TNT trial” and stated that “Our study highlights the importance of weight control as a lifestyle measure to prevent statin-related NODM.”

Due to the fact that a number of patients have used Lipitor unaware of the increased risk for diabetes as a result of the manufacturer’s failure to warn, a number of Lipitor lawsuits have been filed.

If you or a loved one used Lipitor and received a diabetes diagnosis, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Lipitor diabetes lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Lipitor Lawsuit Information page is a great place to start if you have any questions about Lipitor.