Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver function

Christopher M Blanchette, Anthony P Nunes, Nancy D Lin, Kathleen M Mortimer, Joshua Noone, Krishna Tangirala, Stephen Johnston, Benjamin Gutierrez

Article Type

Original Research

Published

Risk evaluation and mitigation strategies (REMS), as mandated by the FDA for medications with the potential for harm, are increasingly incorporating rigid protocols for patient evaluation, but little is known about compliance with these programs. This study assessed adherence to liver function test (LFT) requirements included in the REMS program for bosentan and the results suggest that the program may not have adequately guaranteed adherence to monthly monitoring of LFTs.

Read more

Hemodynamic effect of avanafil and glyceryl trinitrate coadministration

Dennis Swearingen, Ajay Nehra, Susie Morelos and Craig A Peterson

Article Type

Original Research

Published

In this study, investigators examined the magnitude and duration of the interactions (when coadministered with glyceryl trinitrate) of the latest phosphodiesterase type-5 inhibitor avanafil on systolic blood pressure and heart rate compared with sildenafil and placebo.

Read more

Register for alerts

I would like to be contacted by Drugs in Context when new articles are posted.