Pfizer Inc (PFE) Updates U.S. Product Labeling for CHANTIX

July 1, 2009 12:19 PM EDT

Pfizer Inc (NYSE: PFE) has updated the U.S. product labeling for CHANTIX(R) (varenicline), a prescription aid to smoking cessation treatment, to communicate important safety information in a boxed warning as well as in revised warnings and precautions. These updates are based on post-marketing reports and are being made in agreement with the U.S. Food and Drug Administration (FDA). Pfizer is making this information available immediately to U.S. health care providers and patients through multiple communication channels, including letters to doctors and pharmacists, Web site updates, and the CHANTIX patient Medication Guide.

The updated label highlights safety information about reports of serious neuropsychiatric events in a boxed warning; updates the warning about reports of neuropsychiatric symptoms and suicidality; adds warnings about reports of allergic reactions and serious skin reactions; and updates precautionary information about driving or operating machinery to include details about reports of accidental injury.

Certain information on neuropsychiatric symptoms has been included in the CHANTIX label since November 2007 and is based on post-marketing reports. The boxed warning instructs health care providers to observe patients being treated with CHANTIX for the possibility of certain serious neuropsychiatric events and to advise patients to stop taking CHANTIX and contact their doctor immediately if these symptoms occur. It also states that the safety and efficacy of CHANTIX in patients with serious psychiatric illness have not been established. The update advises physicians to provide ongoing monitoring and support for patients who exhibit neuropsychiatric events until symptoms resolve.

The boxed warning also provides important information about the quitting process.

Pfizer is conducting clinical trials of CHANTIX in multiple populations, including in patients with psychiatric disorders and chronic lung disease.

The CHANTIX label updates existing warning information regarding serious neuropsychiatric symptoms to include the types of reports received. It also adds warnings about allergic reactions, such as angioedema, and rare, but serious, skin reactions, such as Stevens-Johnson Syndrome. [SM]

Related Categories

Corporate News
FDA

Stocks Mentioned

Add Your Comment

Name

Subject

Body

Verification can't see the text?
click here to refresh the image.
what's this?