Recently, controversy has arisen over what to call the novel oral anticoagulant class of drugs, which includes Pradaxa, Xarelto, Savaysa, and Eliquis. The article "NOAC, DOAC, or TSOAC: What Should We Call Novel Oral Anticoagulants?" provides some interesting information about the different sides of this debate. Here is a list of the possible … [Read more...]
Archives for September 2016
September 2016 Savaysa Label Change Points Out There Is Still No Antidote
Savaysa (edoxaban) is a factor Xa inhibitor which was approved by the FDA in 2015. Savaysa has the following so-called “indications” or approved uses: To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; and, For the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following … [Read more...]
Adjuvant Chemotherapy Improves Survival in Diffuse Malignant Peritoneal Mesothelioma
This retrospective study evaluated the effects of perioperative treatment options in 126 patients with diffuse malignant peritoneal mesothelioma (DMPM) undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). The 5-year overall survival was significantly different among the perioperative treatment groups: 40% in … [Read more...]
FDA grants fast track designation to galinpepimut-S for malignant plural mesothelioma
The FDA granted fast track designation to galinpepimut-S for the treatment of malignant pleural mesothelioma, according to the drug’s manufacturer. “This fast track designation underscores the importance of galinpepimut-S as a potential treatment option in mesothelioma … [We] expect the fast track designation to expedite the time to market, … [Read more...]
Fosamax – Femur Fracture Lawsuits Wait On Rulings By Court Of Appeals
The federal court Fosamax – femur fracture MDL has been in a “holding pattern” while the parties wait for the appellate court to issue rulings on at least two appeals regarding the Fosamax label, or package insert, information about the femur fracture side effect. And for the New Jersey state court Fosamax litigation, it appears that the presiding … [Read more...]
Modest Results for Checkpoint Agents in Mesothelioma
Two trials presented at the 2016 annual meeting of the American Society of Clinical Oncology (ASCO) provide somewhat discouraging findings on checkpoint inhibitors for second-line treatment of mesothelioma. In the largest checkpoint inhibitor study in mesothelioma to date, a Phase IB study conducted with the programmed death ligand-1 (PD-L1) … [Read more...]
Eliquis Lawsuits Being Filed Across The Country In Increasing Numbers
It is important to know that as of September 2016 Eliquis does not currently have an FDA-approved antidote, or reversal agent, for a patient experiencing a trauma-induced bleeding event or needing emergency surgery. Eliquis (apixaban) was approved by the FDA in December 2012. These serious medical conditions have been associated with the use of … [Read more...]
Nexium / Prilosec / Prevacid Series: Factors for Drug-Injury Lawsuits
This will be the final article of the Nexium, Prilosec, Prevacid blog series. In my previous article, I provided a timeline of the medical literature concerning the link between these PPI drugs and negative kidney side-effects. In this article, I will discuss some of the factors that determine whether a patient may have a viable drug-injury case … [Read more...]
Court rejects $8M verdict in asbestos case
Pointing to problems with expert witnesses, an appeals court Wednesday rejected an $8 million verdict in a case filed by a man who said he suffered mesothelioma because of exposure to asbestos in cigarette filters and in other products. A panel of the 4th District Court of Appeal ordered a new trial for R.J. Reynolds Tobacco Co. and a “directed” … [Read more...]
Arginine deprivation shows promise for malignant pleural mesothelioma
Arginine deprivation with pegylated arginine deiminase may improve PFS and prolong life expectancy in patients with argininosuccinate synthetase 1–deficient malignant pleural mesothelioma, according to the results of a randomized phase 2 trial. The incidence of malignant pleural mesothelioma has risen in the United States and in Europe. The … [Read more...]