Recently, the Food and Drug Administration (FDA) issued a safety announcement to the public stating that the smoking cessation drug Chantix may be associated with an increased risk of certain cardiovascular events especially in patients who have existing cardiovascular disease. This announcement was issued following an FDA review of a clinical trial in which smokers with cardiovascular disease were monitored to determine how much of a risk Chantix posed.
Clinical Trial
There were 700 patients participating in the trial. They each received two doses of Chantix (or placebo) each day for 12 weeks and were followed for an additional 40 weeks. The FDA learned that those who used the drug were twice as likely to stop smoking as those who did not. However, the FDA noted that the trial demonstrated that Chantix may be associated with increased risk of certain cardiovascular adverse events such as heart attack, need for coronary revascularization and peripheral vascular disease, in Chantix users.
The FDA also advised Chantix users to contact their doctor if they experience any new or worsening symptoms of cardiovascular disease, such as:
- Shortness of breath or trouble breathing
- New or worsening chest pain
- New or worsening pain in legs when walking
With this new information, the FDA approved an update to the warnings on Chantix's label. According to an article published by Med Page Today.com, users with COPD or heart problems are advised to start taking the drug seven days before their quit date. They may also begin a Chantix regimen and then quit smoking between day 8 and day 35 of treatment. Ultimately, physicians should weigh the benefits of using Chantix with each patient, along with the potential risks, before prescribing the drug.
