February 2014

In 2011, a report by JD Lewis et al. titled “Risk of bladder cancer among diabetic patients treated with pioglitazone: interim report of a longitudinal cohort study.” published in Diabetes Care states “studies and limited human data suggest a possible increased risk of bladder cancer with pioglitazone therapy” and as such, this was a report “examining the association between pioglitazone therapy and the risk of bladder cancer in patients with diabetes.” (“Pioglitazone” is the chemical name for Actos.)

Patients included in this study numbered 193,099 in total, and consisted of patients from the “Kaiser Permanente Northern California diabetes registry who were ≥40 years of age between 1997 and 2002.”  To make data more clear, patients who previously had bladder cancer were excluded from the study.  Researchers used statistical analysis to compare patients who used Actos to patients who had not used the drug, controlling for “age, sex, race/ethnicity, diabetes medications, A1C, heart failure, household income, renal function, other bladder conditions, and smoking.”

In all, the Lewis et al. (2011) team identified 30,173 diabetic patients who had used Actos.  Among them, researchers found 90 cases of bladder cancer and 791 cases among the about 160,000 non-users.  Though Actos was not found to increase risk for bladder cancer in the short term, use of the drug for longer than 24 months was found to result in a 40% increased risk for bladder cancer.

Thankfully, among patients in this study, 95% of bladder cancer cases were discovered in early stages.

Due to the fact that the manufacturer of Actos has failed time and again to adequately warn users of the risk of bladder cancer, 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 experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

In November 2011, Emily W.Y. Tung and Louise M. Winn of the Department of Pharmacology and Toxicology at Queen’s University in Ontario, Canada published a study titled “Valproic acid-induced DNA damage increases embryonic p27KIP1 and caspase-3 expression: A mechanism for valproic-acid induced neural tube defects” that studied the mechanism by which valproic acid causes neurological birth defects. Valproic acid is the active chemical in antiepileptic drugs Depacon, Depakene, and Depakote.

The abstract of the article begins by stating “Valproic acid (VPA) is a known teratogenic agent that causes neural tube defects.”  Neural tube defects, according to MedlinePlus, a medical encyclopedia curated by the US National Library of Medicine and National Institutes of Health, are described as follows:

“Neural tube defects are birth defects of the brain, spine, or spinal cord. They happen in the first month of pregnancy, often before a woman even knows that she is pregnant. The two most common neural tube defects are spina bifida and anencephaly. In spina bifida, the fetal spinal column doesn’t close completely. There is usually nerve damage that causes at least some paralysis of the legs. In anencephaly, most of the brain and skull do not develop. Babies with anencephaly are either stillborn or die shortly after birth. Another type of defect, Chiari malformation, causes the brain tissue to extend into the spinal canal.”

Tung and Winn write that “[Neural Tube Defects (NTDs)] are one of the more common birth defects seen worldwide, occurring at a rate of 0.5–2 per 1000 pregnancies,” but that “Exposure to VPA during the first trimester of pregnancy results in a 1–2% incidence of NTDs in infants, which is 10–20 times the rate seen in the general population”.  For this reason, these researchers consider valproic acid to be a “model teratogen to study NTDs.”

In their study, this team used rodent models and found that valproic acid during pregnancy caused an increase in production of the protein yH2A.X, used as a marker indicating that the drug had induced “double strand breaks” in the DNA of animals (yH2A.X helps repair broken DNA).  This breaking in DNA limits DNA’s ability to replicate and thus inhibiting normal development.

Sadly, the manufacturer of Depacon, Depakene, and Depakote failed to adequately warn users of the risk for neural tube defects associated with these drugs.  As a result, a number of Depacon / Depakene / Depakote neural tube defects lawsuits have been filed.  If you or a loved one used one of these drugs during pregnancy and your child was born with a neural tube defect, you too may be entitled to significant financial compensation.

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

(855) 452 – 5529

justinian@dangerousdrugs.us

In a 2013 study published in Reproductive Toxicology by Matteo Cassina et al. titled “Pregnancy outcome in women exposed to antiepileptic drugs: Teratogenic role of maternal epilepsy and its pharmacologic treatment” aimed to further evaluate the connection between valproic acid (the active ingredient in DepaconDepakene, and Depakote) and serious birth defects.

The paper on this study begins simply, stating that “Infants born to epileptic women have an increased risk of major congenital malformations”, “Prenatal exposure to antiepileptic drugs is the main cause of birth defects” and “The teratogenic role of maternal epilepsy cannot be excluded.”  That is, some research has suggested that mothers simply having epilepsy will result in an increased risk for birth defects, regardless of drug use.  However, many studies have determined that antiepileptic drug use raises the risk for birth defects over and above the existing risk for defects associated with unmedicated epilepsy.

To clarify this, Cassina et al. (2013) studied three groups of pregnant women and compared birth outcomes between them.  The groups were as follows: “385 epileptic women treated with AEDs,” “310 non-epileptic women treated with AEDs,” and “867 healthy women not exposed to AEDs (control group).”

This allows researchers to see whether it was drugs or epilepsy that led more to birth defects.  After statistical analysis, the team determined that the rate of birth defects among children born to mothers who suffered from epilepsy did not differ from the non-epileptic group, but that the rate for birth defects was higher in children born to epileptic drug-using mothers than in the control group.

“The rates of congenital malformations in the AEDs-exposed cohorts were higher than in the control group, being 7.7% in the epileptic cohort, 3.9% in the non-epileptic cohort and 3.1% in the control group.”

The team writes “It has become apparent … that the rate of congenital malformations significantly increases in newborns exposed to AEDs during the first trimester of pregnancy and it is higher if more than one AED is taken, it is dose dependent and affected by other variables such as parental history of MCMs. The highest risk has been observed with high dose of valproic acid exposure as compared to other AEDs such as carbamazepine, phenytoin and lamotrigine.”

Due to the fact that the manufacturer of Depacon / Depakene / Depakote have failed time and again to adequately warn users of the risk for birth defects associated with this medication, a number of Depacon / Depakene / Depakote lawsuits have been filed.  If you or a loved one used one of these drugs containing valproic acid and your child was born with a congenital malformation, you may be entitled to significant financial compensation for the undue injury to your child.

For a free, no-obligation case consultation, contact our team of Depacon birth defect 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 Depacon Lawsuit Information page is a great place to start if you have any questions about Depacon.

In a 2013 article published in the December issue of Journal of Gastric Cancer titled “Emerging Role of Robot-assisted Gastrectomy: Analysis of Consecutive 200 Cases.”, a team of researchers led by JY Park “aimed to evaluate whether gaining experience in robotic gastrectomy could improve surgical outcomes in the treatment of gastric cancer.”  In recent years, surgical robots (particularly those by Da Vinci) have become increasingly common in the operating room, and this study wanted to evaluate their safety and efficacy for gastrectomy – surgical removal of all or part of the stomach.

In this study, researchers evaluated how well the procedure went for the first 100 patients seen at a certain center (while surgeons were still learning to use the surgical robots) and another 100 patients who were operated upon once surgeons were better trained with surgical robots.

Results showed that “Twenty patients developed postoperative complications. Thirteen were managed conservatively, while 6 had major complications requiring invasive procedures. One mortality occurred owing to myocardial infarction.”

Research demonstrating rates of complications as high as 20% demonstrates that though sometimes robotic surgery is safe, it is absolutely not in all cases.  It was in fact shown by this paper that rates of complication and length of surgery time and hospital stay decreased with surgeon training, but regardless, these rates of complications are exceedingly high.

Due to the fact that Da Vinci, the manufacturer of many popular surgical robots has failed to adequately warn of the risk for complications without extensive surgeon training, merely “recommending” that surgeons be trained, a number of Da Vinci surgical robot lawsuits have been filed by patients who faced complications after surgery.

If you or a loved one underwent surgery in which Da Vinci surgical robots were used, you may be entitled to compensation for injury or undue risk of injury you endured.  For a free, no-obligation case consultation, contact our team of Da Vinci Surgical Robot lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

An article published earlier this month (February 2014) titled “Systematic Review and Meta-analysis of Robotic vs Conventional Thyroidectomy Approaches for Thyroid Disease.” by GH Sun et al. in Otolaryngology provides us with helpful insight into the relative safety and efficacy of surgical robots, which have become increasingly prevalent in the modern operating room, at least for certain procedures.

This article compares the outcomes for traditional thyroidectomy and robotically-assisted thyroidectomy “for thyroid nodules and cancer.”  For data, this study team “examined relevant controlled trials, comparative effectiveness studies, and cohort studies for eligible publications” and “calculated the pooled relative risk for key postoperative complications, mean differences for operative time, and standardized mean differences for length of stay (LOS) using random effects models.”

Using a total of 11 studies comprised of a total of 726 patients who underwent robotic surgery and 1205 patients who underwent conventional surgery, the team used a series of statistical analyses to determine which procedure was more safe and effective.  Sun et al. (2014) write “Mean operative time for robotic thyroidectomy exceeded open thyroidectomy by 76.7 minutes”, but note that “There were no significant differences in hematoma, seroma, recurrent laryngeal nerve injury, hypocalcemia, or chyle leak rates.”

However, the team concludes that “Transaxillary and axillo-breast robotic and open thyroidectomy demonstrate similar complication rates, but robotic approaches may introduce the risk of new complications and require longer operative times.” (emphasis added)

Due to the fact that Da Vinci, the manufacturer of many popular surgical robots has failed to warn users of the increased risk for complications associated with its products, a number of Da Vinci surgical robot lawsuits have been filed.  If you or a loved one underwent surgery in which Da Vinci surgical robots were used and faced complications, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Da Vinci surgical robot lawyers at the information provided below.  We have the compassion, experience, and resources required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

As lawsuits concerning the testosterone therapy drug AndroGel have recently been filed, a great deal of information has come to light concerning the marketing of that product.

Here is an excerpt from one of the current AndroGel lawsuits:

“In 2000, when the FDA approved AndroGel, the company announced that the market was ‘four to five million American men.’ By 2003, the number increased to ‘up to 20 million men.’ However, a study published in the Journal of the American Medical Association (‘JAMA’) in August 2013 entitled ‘Trends in Androgen Prescribing in the United States, 2001-2011’ indicated that many men who get testosterone prescriptions have no evidence of hypogonadism. For example, one third of men prescribed testosterone had a diagnosis of fatigue, and one quarter of men did not even have their testosterone levels tested before they received a testosterone prescription.”

Does it really seem likely that the prevalence of hypogonadism would quadruple in three years, or does this simply look like a case of improper marketing?  It is interesting to note that when then-manufacturer of AndroGel, Unimed Pharmaceuticals, Inc., first sought AndroGel approval by the FDA in 1999, “hypogonadism was estimated to affect approximately ‘one million American men.’”  A twenty-fold increase in disease prevalence is staggering, and would represent an epidemic if it were real.  Thankfully, it isn’t.

However, the good news that hypogonadism isn’t so prevalent may likely be eclipsed by the prevalence of AndroGel use and the accompanying negative side effects — which include a dramatically-increased risk for heart attack and stroke.

In August 2013, an article titled “Risk of bladder cancer in diabetic patients treated with rosiglitazone or pioglitazone: a nested case–control study.” was published by F.Y. Hsiao et al. in the medical journal Drug Safety that aimed to evaluate the connection between rosiglitazone (Avandia) and bladder cancer and between pioglitazone (Actos) and bladder cancer.  The team writes “Evidence has emerged that pioglitazone may increase the risk of bladder cancer, but the association has not been confirmed. This potential risk also has not been evaluated in users of rosiglitazone.”

To obtain data for this study, Hsiao et al. searched through Taiwan’s National Health Insurance Database and identified “3,412 cases of newly diagnosed bladder cancer and 17,060 controls”.  Control subjects were those who had diabetes but used neither Avandia nor Actos.

After a series of statistical analyses, the team determined that both Actos and Avandia were associated with bladder cancer.  Use of Actos for less than one year made one 45% more likely to develop bladder cancer, use of Actos for 1-2 years made patients 74% more likely, and use of Actos for more than two years made people about 3 times as likely to develop bladder cancer than non-exposed patients.

Concerning Avandia, patients were 78% more likely to develop bladder cancer with 1-2 years of use, and twice as likely to develop bladder cancer with more than two years of use.

Due to the fact that a number of people have used Actos and Avandia unaware of the risk for bladder cancer associated with these drugs, 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 your injuries.

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

In 2013, a team of researchers led by RM Turner published a report in British Journal of Clinical Pharmacology that evaluated the connection between the thiazolidinedione class of drugs and the onset of bladder cancer.  Drugs in that class include diabetes drugs Avandia and Actos.

Evaluating 18 previously-conducted studies (13 observational studies and 5 randomized controlled trials), researchers write that “Meta-analysis showed a significantly higher overall risk of bladder cancer with pioglitazone in [randomized controlled trials] (7,878 participants; OR 2.51, 95% CI 1.09-5.80) and observational studies (>2.6 million patients; OR for ever-users vs. non-users 1.21 (95%CI 1.09-1.35).”  This means that the risk for bladder cancer among Actos (pioglitazone) users is between 21% and 251% higher than the risk faced by non-users.

Further, the study found that those who had consumed more than 28 grams of Actos total in the course of their diabetes treatment were 64% more likely to develop bladder cancer. This study did not find an association between bladder cancer and Avandia, though others have.

Sadly, the manufacturer of Actos failed time and again to notify users of the risk for bladder cancer, and accordingly, a number of Actos 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 your undue injury.  For a free, no-obligation case consultation, contact our team of Actos lawyers at the information provided below.  We have the compassion, experience, and resources required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

In 2013, a report by M. Ferwana et al. titled “Pioglitazone and risk of bladder cancer: a meta-analysis of controlled studies.” was published in Diabetes Medicine that sought to evaluate the connection between the diabetes drug Actos and new-onset bladder cancer.

Living up to its name, this report reviewed data from six previous studies including a total of 215,142 Actos patients.  The team writes “The hazard of developing bladder cancer was significantly higher in patients using pioglitazone (hazard ratio 1.23; 95% CI 1.09-1.39; I(2) = 0%) compared with control groups.”  (For clarity, “pioglitazone” is the chemical name for Actos.)  What this data means is that patients using Actos were found to face a risk for bladder cancer elevated by 23%.

Unfortunately, the manufacturer of Actos failed to make this risk clear to users, and many people taking Actos developed bladder cancer unaware that the medication they used could have such terrible results.  As a result of this, a number of Actos lawsuits have been filed seeking compensation from the manufacturer for the undue injuries of Actos patients.

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 skills, resources, and experience required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

In 2012, a study by Z. Zhu et al. titled “Increased risk of bladder cancer with pioglitazone therapy in patients with diabetes: a meta-analysis.” aimed to “examine the association between pioglitazone therapy and bladder cancer in patients with diabetes.”  To be clear, “pioglitazone” is the chemical name for the diabetes drug Actos, manufactured by Takeda Pharmaceuticals, Inc.

Reviewing five separate previously-conducted studies that among them included over 2.3 million patients, Zhu et al. (2012) found that Actos use was “associated with a significantly higher risk of bladder cancer”.  Overall, the use of Actos was determined to raise risk for bladder cancer by 17% over non-users, but if patients used Actos for 1-2 years, the risk jumps to 34%, and if Actos is used for more than two years, the risk was shown to jump to 38%.

Like other studies, this study also found that the risk for bladder cancer was particularly elevated if a patient used more than 28,000 mg of Actos total, over the course of treatment.  Here, the risk for bladder cancer was found to be 58% higher than for non-users.

Due to the fact that Takeda knew Actos was associated with bladder cancer and failed to act, 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 may be entitled to significant financial compensation for your undue injuries.  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