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

Monthly Archives: February 2014

Generic Drug Industry Pushback Over New FDA Regulations

Posted in FDA Regulation

A recent article in the Los Angeles Times discusses industry pushback against proposed federal legislation that would allow the manufacturers of generic pharmaceutical drugs the ability to “inform people about all known health risks” associated with various drugs produced.  The Generic Pharmaceutical Association was quoted saying that the new regulations “would create ‘dangerous confusion’ and… Continue Reading

Ethicon and its Faulty Pelvic Mesh Devices: Destroying Valentine’s Day…and Implicating Documents

Posted in Vaginal Mesh

Part I: Destroying Valentine’s Day Two weeks ago was Valentine’s Day— a holiday that is supposed to be full of romance and heartfelt encounters with those you love. For many lucky people, Valentine’s Day was exactly that this year. Countless couples across the country could be seen on dates, filling restaurants, theaters, and dance-halls to… Continue Reading

Verdict in Favor of Ethicon: No Big Win in the Grand Scheme of Things

Posted in Vaginal Mesh

Over the course of the past several days, Ethicon, a Johnson & Johnson company, has crowed over the fact that it “prevailed” in a lawsuit regarding the pelvic mesh devices it manufactured and promoted. At first glance, the media headlines regarding Ethicon’s recent “triumph” are confusing, and might even make it seem like Ethicon has… Continue Reading

AndroGel and False Claims of Low Testosterone: Dying to be a Man…Literally

Posted in Androgel

The alpha-male. It’s a term traditionally used to describe an individual male mammal that is considered to hold the highest social standing in his community. Typically, an animal rises to alpha-male status by exhibiting signs of masculinity, confidence, and aggression to his peers. In acknowledgement of the alpha’s strength and leadership role, other members of… Continue Reading

2014 – Serious ailment likely the result of surgical robots

Posted in Surgical Robots

An article published in the January-February, 2014 edition of Female pelvic medicine and reconstructive surgery titled “Pneumomediastinum after robotic sacrocolpopexy.” reviews a case of pneumomediastinum in a woman who underwent robot-assisted surgery for the repair of posthysterectomy prolapse.  The team writes “Pneumomediastinum is a rare but potential complication of laparoscopy that is related to insufflation… Continue Reading

2012 – Actos raises risk for bladder cancer 15-40%

Posted in Surgical Robots

In 2012, an article titled “Use of thiazolidinediones and the risk of bladder cancer among people with type 2 diabetes: a meta-analysis.” was published by IN Colmers et al. in Canadian Medical Association Journal investigating the relationship between Actos and bladder cancer.  Thiazolidinediones are a class of diabetes drugs including pioglitazone, the chemical name for… Continue Reading

2013 – 21% complication rate with robot-assisted surgery

Posted in Surgical Robots

In the December, 2013 edition of European Urology, a team of researchers led by RK Kumar published the results of a study titled “Robot-assisted Partial Nephrectomy in Patients with Baseline Chronic Kidney Disease: A Multi-institutional Propensity Score-Matched Analysis.” that aimed to evaluate the relative safety of robot-assisted nephrectomy, as compared with a traditional approach that… Continue Reading

2014 – Longer operating time, more pain with surgical robots

Posted in Surgical Robots

A recent article published in the January 2014 edition of Obstetrics and Gynecology titled “Robotic compared with laparoscopic sacrocolpopexy: a randomized controlled trial.” lives up to its title and compares the safety and efficacy of robot-assisted to traditional sacrocolpoplexy. The team, led by JT Anger, writes “Laparoscopic and robotic sacrocolpopexy are widely used for pelvic… Continue Reading

2014 – High rate of complications seen with robot-assisted surgery

Posted in Surgical Robots

In 2014, an article by AM Coker et al. titled “Outcomes of robotic-assisted transhiatal esophagectomy for esophageal cancer after neoadjuvant chemoradiation.” in Journal of Laparoendoscopic & Advanced Surgical Techniques aimed to “determine if [robotic-assisted transhiatal esophagectomy (RATE)] could be performed safely with good outcomes for esophageal cancer in a more recent series of patients”. The… Continue Reading

2012 – Long term Actos use doubles risk for bladder cancer

Posted in Actos & Bladder Cancer

In 2012, an article by L. Azoulay et al. titled “The use of pioglitazone and the risk of bladder cancer in people with type 2 diabetes: nested case-control study.” aimed to “determine if the use of pioglitazone is associated with an increased risk of incident bladder cancer in people with type 2 diabetes.”  (“Pioglitazone” is… Continue Reading

2011 – Actos dramatically raises risk for bladder cancer

Posted in Actos & Bladder Cancer

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… Continue Reading

2011 – Study connects Depakote and neural tube defects

Posted in Depacon / Depakene / Depakote

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… Continue Reading

2013 – More research published linking Depacon / Depakote / Depake with birth defects

Posted in Depacon / Depakene / Depakote

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 Depacon, Depakene, and Depakote) and serious birth defects. The paper on this… Continue Reading

2013 – 20% complication rate seen with surgical robots

Posted in Surgical Robots

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,… Continue Reading

2014 – Study finds surgical robots “introduce the risk of new complications”

Posted in Surgical Robots

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… Continue Reading

AndroGel manufacturer stirs up undue concern over “low-T”

Posted in Androgel, Lawsuits

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… Continue Reading

2013 – Two years of Actos use found to double risk for bladder cancer

Posted in Actos & Bladder Cancer

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… Continue Reading

2013 – Risk for bladder cancer associated with Actos ranges from 21% to 251% increase

Posted in Actos & Bladder Cancer

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… Continue Reading

2013 – Study shows Actos use raises risk for bladder cancer by 23%

Posted in Actos & Bladder Cancer

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… Continue Reading

2012 – Huge study links Actos and bladder cancer

Posted in Actos & Bladder Cancer

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… Continue Reading

2013 – “Increased risk of bladder cancer” associated with Actos

Posted in Actos & Bladder Cancer

An article published in a 2013 edition of Tumour Biology titled “Pioglitazone prescription increases risk of bladder cancer in patients with type 2 diabetes: an updated meta-analysis.” by S. He et al. aimed to determine the risk for bladder cancer associated with use of pioglitazone (Actos; Tadeka Pharmaceuticals, Inc.). The authors of this paper write… Continue Reading

2012 – Actos associated with 22-75% increased risk for bladder cancer

Posted in Actos & Bladder Cancer

In 2012, A. Neumann et al. published a study titled “Pioglitazone and risk of bladder cancer among diabetic patients in France: a population-based cohort study.” in Diabetologica that studied the risk for bladder cancer among French diabetic patients using Actos (pioglitazone), a drug used to control blood sugar manufactured by Tadeka Pharmaceuticals, Inc. According to… Continue Reading

February 2014 – AndroGel Lawsuit Filed in Federal Court

Posted in Androgel, Lawsuits

WARNING: Research shows AndroGel (AbbVie, Inc., Abbott Laboratories, Inc.) is overprescribed and can lead to “serious medical problems, including life threatening cardiac events, strokes, and thrombolytic events.” AndroGel is a topically-applied gel containing testosterone at concentrations of either 1% or 1.62% used by patients suffering from hypogonadism, or “low-testosterone”.  While this condition does persist in… Continue Reading

FDA Cites Three Cases of Diabetes Associated with Abilify

Posted in Uncategorized

Between 2008 and 2009, a number of adverse events were reported to the FDA regarding second-generation (atypical) antipsychotic drugs Seroquel (quetiapine fumarate), Risperdal (risperidone), Zyprexa (olanzapine), Geodon (ziprasidone), and Abilify (aripiprazole) among children aged 6-17. Click here to read the full FDA Adverse Event Report on Atypical Antipsychotics among children (2008-2009). The report states that… Continue Reading