|
 Champix is approved as an effective therapy for helping smokers quit
but the European Medicines Agency added a "black triangle" warning
following reports linking it to agitation, aggression, panic,
anxiety, depression and suicidal thoughts.
The special warning required additional safety monitoring for
patients taking the medicine.
Pfizer said on Monday that experts at the European drugs watchdog
had now adopted a decision to change the label in the light of
results from a large study, published in The Lancet medical journal
in April, that provided safety reassurance.
Pfizer's medicine, which has been prescribed to millions of patients
around the world, also carries a "black box" warning in the United
States relating to neuropsychiatric adverse events.
A Pfizer spokesman said the company was awaiting feedback from the
U.S. Food and Drug Administration on the matter.
[to top of second column] |
(Reporting by Ben Hirschler; editing by Jason Neely)
[© 2016 Thomson Reuters. All rights
reserved.] Copyright 2016 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
 |
