Arthritis related pain and safety concerns of NSAIDs

This month, the December 2012 issue of the Open Rheumatology Journal published an online article from a group that was brought together for a meeting in Aachen, Germany by Grünenthal GmbH, a pharmaceutical company.  The authors were compensated for their time and had assistance in the writing of the publication, which was funded by Grünenthal.

The article describes osteoarthritis and rheumatoid arthritis, as well as multiple therapies.  It concludes that the use of combinations of medications, as well as a multimechanistic approach are what is needed to help avoid the long-term potential safety concerns associated with NSAIDs. 

Inconsistency seen in safety labeling for generic drugs

An article published in  Pharmacoepidemiology and Drug Safety notes that over two-thirds of generic drugs in the U.S. have safety warning labels that differ from the equivalent brand-name medications.

According to the lead author, Jon Duke, "generic drug labels may contain incomplete or incorrect safety information."  This becomes problematic when the generic label is used by the physician to make prescribing decisions. If side effects, information on durg interactions or other safety issues are not in the label, then the patient may be at an increased risk for adverse events.

Out of more than 1,000 generic drugs, nearly 70% had some discrepancies in their safety labeling. Strikingly,  9% had differences of more than 10 side effects.

Androgen deprivation and prostate cancer

Saylor and Smith of the Massachusetts General Hospital Cancer Center in Boston, Massachusetts have an article that is coming out in the Journal of Urology in January 2013 which discusses adverse effects of androgen deprivation therapy (ADT).  Their review focuses on the more recently described metabolic complications of ADT including obesity, insulin resistance and lipid alterations as well as the association of androgen deprivation therapy with diabetes and cardiovascular disease.

They found that ADT causes a decrease in lean mass (muscle) and an increase in the mass of fat.  This was associated with a decrease in insulin sensitivity and increase in LDL, HDL and triglycerides.  This is associated with an increase in the incidence of diabetes and cardiovascular disease.

The benefit versus the risk of ADT must be considered when considering treatment, and it is recommended to screen for risk factors associated with diabetes and cardiovascular disease  and treat as indicated, thus mitigating the adverse effects that can be associated with ADT.

Mobile App for Oncology Adverse Events And Graft-Versus-Host Disease

Velos Aversi, an iPad app for clinicians in oncology and bone marrow transplantation has recently been released.

Velos Aversi is designed to record, track, and export patient adverse events (AE) and Graft-Versus-Host Disease (GVHD) at point-of-care in hospital and ambulatory care settings. With a few touches on the iPad, clinicians, physicians, and research nurses can review and manage their patients’ AE and GVHD histories anytime, anywhere—freeing them from large and cumbersome paper files. The app allows for more accurate attribution and reduces transcription errors that can occur when AE data entry is delayed. Direct and immediate input by clinicians saves time and ensures the quality of the record, particularly when grading events.

Antinausea Drug Withdrawn From US Market

The FDA announced that the 32 mg dose of Zofran (ondansetron), an anti-nausea medication, will no longer be marketed in the US due to the potential the risk of Torsades de pointes, a serious cardiac rhythm abnormality.  The event occurs when there is a prolongation in the QTc interval, an important part of the electrical activity of the heart.  Prolongation of the QTc can be fatal.  Information from the FDA can be found here.