ptsd Vaoig Finds Va Chantex

[Berta]

http://www.vawatchdog.org/08/nf08/nfaug08c/nf083008-3.htm

In part:

"We found that the VAMCDC Pharmacy Service responded appropriately to FDA communications concerning Chantix® in November 2007 and in February 2008 in notifying providers of these newly defined risks. However, we found that the Research Service did not ensure that patients with post-traumatic stress disorder (PTSD) who were also enrolled in a smoking cessation study received adequate and timely notice of these risks. We further found that the facility failed to ensure that patients in this study who had taken Chantix® signed an addendum to the consent form disclosing these risks. While the facility mailed information letters to participants in late February or early March 2008, we also noted that the facility did not document or ensure that participants actually received this notification."