Posts Tagged ‘varenicline’

December 12th, 2012

FDA: Small, Nonsignificant Risk from Chantix

The FDA today updated its safety review of the smoking cessation drug varenicline (Chantix, Pfizer). A large meta-analysis, which the FDA had required Pfizer to perform, found a higher rate of major adverse cardiovascular events (MACE) in patients taking varenicline than in patients taking placebo. However, the increase in risk was very small and did not achieve statistical significance. […]

May 14th, 2012

Selections from Richard Lehman’s Literature Review: Week of May 14th

This week Richard discusses studies of glucose, insulin, and potassium for MI, elective PCI with and without surgical standby, and varenicline and CV risk.

May 4th, 2012

Reanalyzed Chantix Data Yield Smaller CV Risk, New Controversy

A new meta-analysis criticizes earlier work warning that the smoking-cessation drug varenicline (Chantix) poses increased cardiovascular risks. The analysis appears in BMJ. It was performed by researchers with no current ties to the drug maker, but one of whom had received a Pfizer investigator-initiated research award. The new analysis examined the risk of treatment-emergent serious cardiovascular events […]

July 21st, 2011

FDA and EMA Issue Updates on Dronedarone, Varenicline, and Pioglitazone

The FDA has issued an update on dronedarone (Multaq, Sanofi Aventis), and the European Medicines Agency (EMA) has updated its reviews of dronedarone and 2 other drugs that also have been the subject of recent controversies: pioglitazone (Actos and other names, Takeda) and varenicline (Champix, Pfizer). The FDA and dronedarone: The FDA issued a safety communication about […]

July 4th, 2011

Meta-Analysis: Increased CV Risk Associated with Varenicline (Chantix)

The anti-smoking drug varenicline (Chantix, Pfizer) is associated with an increased risk for serious adverse cardiovascular events, according to a new meta-analysis published in CMAJ. In the meta-analysis, Sonal Singh and colleagues analyzed data from 14 double-blind randomized trials involving 8216 subjects. The rate of serious adverse cardiovascular events was 1.06% (52/4908) among varenicline recipients versus […]

June 16th, 2011

FDA: Varenicline (Chantix) May Increase Risk for CV Events

The FDA said that the anti-smoking drug varenicline (Chantix) may increase the risk for cardiovascular events in people who already have cardiovascular disease. The new information will be added to the drug’s label and Medication Guide for patients. The FDA does not recommend that people with cardiovascular disease stop taking varenicline, but it says that physicians […]