20
fhea.com Fitzgerald Health Education Associates, Inc., March 2015
ed the risk for neuropsychiatric side effects on
mood, behavior, or thinking that occurred with
varenicline, which were the subject of previous
FDA alerts. The FDA has not yet been able to draw
reliable conclusions from these studies, but further
studies are under way, with results expected late
in 2015.
Certain Hepatitis C Meds Linked with
Serious Bradycardia
The FDA is warning that serious and life-threatening
symptomatic bradycardia can occur when amio-
darone is taken together with either ledipasvir/so-
fosbuvir (Harvoni) or with sofosbuvir (Sovaldi) taken
in combination with another direct-acting antiviral
for the treatment of hepatitis C infection. The FDA is
adding information about symptomatic bradycardia
to the labels of Harvoni and Sovaldi and is recom-
mending that healthcare
providers should not pre-
scribe either Harvoni or So-
valdi combined with another
direct-acting antiviral, such as
the investigational drug da-
clatasvir or simeprevir (Olysio),
with amiodarone.
The FDA's review of postmarketing adverse event
reports found that patients can develop a serious
and life-threatening symptomatic bradycardia when
either Harvoni or Sovaldi combined with another
direct-acting antiviral is taken together with amio-
darone. Reports included the death of one patient
from cardiac arrest and three patients requiring
placement of a pacemaker to regulate heart
rhythms. The other patients recovered after discon-
NP Firsts News Briefs
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