Many would agree that kicking the habit of smoking is definitely worth the health benefits in the long run. But, are the smoking cessation products that are available on the market worth the health risks involved with each? Perhaps not.
A meta-analysis ordered by the agency and conducted by drugmaker Pfizer found a higher occurrence of major adverse cardiovascular events — including death and stroke — with the drug than with a placebo.
The FDA noted, however, that such events were uncommon in both groups, and the increased risk wasn’t statistically significant.
The agency said clinicians need to weigh the risks of the drug against the benefits of its use, noting that smoking is itself already a risk factor for heart disease.
Chantix is the top-selling smoking cessation drug in the U.S., according to IMS Health. It works by blocking the effect of nicotine in the brain. Studies have shown that about 20% of people who take Chantix quit smoking long-term compared to 10% of those who take placebos.
Last year, the FDA issued a warning about heart risks tied to the drug and ordered Pfizer to conduct additional safety studies.
The FDA required a change in the drug’s warning label about heart risks in June 2011, after a randomized controlled trial found a higher risk of cardiovascular events with the drug. It requested the current meta-analysis when the labeling change was ordered.
Varenicline has also been associated with reports of depression and suicidality, and the FDA ordered a labeling change warning about risks of neuropsychiatric symptoms in 2009.
Subsequent FDA reviews, however, found no increased risk of psychiatric events — although some studies criticized those conclusions.
A recent study reported by Pfizer also found no increased risk of depression or suicidality with the drug.
The updated safety review included more than 7,000 smokers. Those who took Chantix for three months suffered more major cardiac events — those included deaths due to heart problems as well as heart attacks and strokes that weren’t fatal — than those who took a placebo.
But heart problems were rare in both groups. Just 13 out of 4,190 people (or 0.31%) who took Chantix suffered a major heart event compared to six out of 2,812 people (or 0.21%) who were taking a placebo.
The difference between the two groups may have simply been due to chance and not to any real effect of the drug.
“However, the data were analyzed many different ways and consistently showed a higher occurrence of events in patients using Chantix, which makes it seem more likely that it is related to the drug and not purely a chance finding,” says the FDA report.
Experts say the bottom line is that smokers should carefully weigh the risks and benefits of taking the drug against the risks of smoking. Smokers have two to four times the risk of developing heart disease compared to nonsmokers, according to the CDC.
“Patients have to use this information along with their physicians, and they have to be aware of these risks,” says Sonal Singh, MD, MPH, an assistant professor of medicine and public health at Johns Hopkins University in Baltimore, Md.
“Smoking is a terrible disease. I think people need all options to help them quit,” Singh says.
“What I do with my patients is that I try other options first,” says Singh, who led the 2011 safety review of Chantix. “After you’ve exhausted all other options, and other safer, cheaper options, then you try this. I think that’s very reasonable.”
Other experts agree that the benefits of taking the drug may be worth the risks for people with serious addictions.
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