After finding potential carcinogens in some lots of Chantix, Pfizer (PFE) late last month halted worldwide distribution of its smoking cessation pill.
The drug maker, which is now running tests, took this step after finding nitrosamine levels that were above an “acceptable” daily intake, according to the company. Consequently, regulators in Canada and South Korea, for instance, have posted recall notices for the medicine, which is called Champix outside the U.S. Pfizer also sent letters to distributors about its actions.
“We believe the benefits (of the drug) outweigh the very low potential risks, if any, posed by nitrosamine exposure… on top of other common sources over a lifetime,” a Pfizer spokesperson wrote us. “We have worked hand-in-hand with regulatory authorities around the world who are taking varying approaches and have varying timelines” for communicating information.
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and networking platform access.
Already have an account? Log in
Already have an account? Log in
About the Author Reprints
To submit a correction request, please visit our Contact Us page.
STAT encourages you to share your voice. We welcome your commentary, criticism, and expertise on our subscriber-only platform, STAT+ Connect