February 2012 Drug Update Information - Pharmacy Benefits ...

Studies
Article Link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm287710.htmm
Source website: http: ://www.fda.gov/default.htm
Tysabri (natalizumab): Drug Safety Communication
- New Risk
Factor for Progressivee
Multifocal Leukoencephalopathy (PML)
[Posted 01/20/2012]
ISSUE: FDA notified
healthcare profesisonals that testing positive for anti-JC virus (JCV)
antibodies has been identified as a risk factor
for progressive multifocal leukoencephalopathy
(PML). PML is a rare
but seriouss brain infection associated with use
of Tysabri (natalizumab) for
the treatment of multiple sclerosis (MS) or Crohn's disease.
A patient's anti-JCV antibody status may be determined using an anti-JCV antibody detection
test that has been analytically and
clinically validated, and has been ordered by a healthcare
professional. The Stratify JCV Antibody ELISA test2 was cleared by
FDA on January 20, 2012.
Testing positive for anti-JCV antibodies means that a person has been exposed to
JCV in the
past.
BACKGROUND: Tysabri (natalizumab) is in a class of medicationss called immunomodulators.
It works by stopping certain cells
of the immune system from causing damage to
the body.
Tysabri is approved for the treatment of relapsing forms of multiple sclerosis since November
2004 and
for the treatment of moderately to severely active Crohn's disease since
January 2008.
RECOMMENDATION: The risks and benefits of continuing treatment with Tysabri should be
carefully
considered in patients who are found to be anti-JCV antibody positive and have one or
more of the other known risk factors for PML. Patients with all threee known risk
factors have an
estimated
risk of PML of 11/1,000 users.
Article Link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm288602.htmm
Source website: http: ://www.fda.gov/default.htm
Drug Coatings Can Contain Problematic Chemicals
December 22, 2011
Potentially harmful chemicals show up in a wide variety of drugs and
supplements, especially
ones with
time-release coatings. A large number of common drugs and supplements contain
chemicals called phthalates, which are often found in plastics, found
a new study. These
chemicals have been linked to a variety of hormonal andd reproductive problems in both rats and
people.
Article link: http://news.discovery.com/human/pill-coatings-chemicals-hormones-111222.html
Source website: http: ://news.discovery.com/
Bristol-Myers Says Liver Cancer Drug Didn’t Meet Goals in Trial
December 23, 2011
Bristol-Myers Squibbb Co. said its experimental brivanib drug for liver cancer didn’t improve
patient survival better than a placebo. The study, one of four final-stage clinical trials evaluating
brivanib in liver cancer, tested the experimental drug in patients who
failed on or
were intolerant
to Nexavar, the liver cancer drug
from Onyx Pharmaceuticals Inc. and Bayer AG, Bristol said
today in a statement. New York-based Bristol will continue with the other trials, it said.
Article link: http://www.bloomberg.com/news/2011-12-22/bristol-myers-says-liver-cancer-
drugdidn-t-meet-goals-in-trial.html
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