Chantix

Varenicline

For Smoking Cessation

Track record

More

Medium (approved in 2006)

Special FDA warning?

More

Yes - FDA requires black box warning

Bottom line

More

Smoking Cessation

What is Smoking Cessation?

More

Other treatments for Smoking Cessation

More

Non-drug

Over-the-counter

Prescription

TABLE OF CONTENTS

Overview

FDA-approved use

To help you stop smoking

Who might consider taking it?

Adults who want to stop smoking

Quitting smoking can lower your chances of having lung disease, heart disease or getting certain types of cancer that are related to smoking

What is not known

Not tested in children younger than age 18

Not tested in combination with other medicines to quit smoking

Not tested in people with schizophrenia, bipolar disorder, or major depression at time of approval

Since approval there is limited safety data about use of Chantix in patients with major depressive disorder and stable schizophrenia or schizoaffective disorder - but available data not sufficient to draw conclusions about safety

Not tested in people with unstable heart disease or a recent heart attack

Track record

Medium track record means that new‚ unexpected side effects are possible

Chantix was approved by FDA in 2006 for smoking cessation. Important side effects may emerge after Chantix is on the market when larger numbers of people - with other conditions and on other medications - have used the drug.

Open questions

FDA-required studies at approval to answer questions about benefit and harms

The drug company was required to conduct additional studies about the benefit and possible side effects in adolescents 12 to 16 years old

Do not take if you...

Are allergic to Chantix or its ingredients

Are breastfeeding

Safe if pregnant or breastfeeding?

Pregnant

Only take if potential benefits outweigh potential harm to baby (FDA Category C)

Breastfeeding

Do not breastfeed while taking Chantix - either stop breastfeeding or stop Chantix

NEXT: TRIALS

Want to View More Content?