(NaturalNews) Early in June, the FDA released a report officially linking the smoking cessation drug Chantix to an increased risk of cardiovascular health problems including heart attacks.
The increased heart attack risk is low and is noted primarily among those who are already experiencing problems with their cardiovascular health, but the connection has been proven conclusively, and has led to FDA to require a new series of randomized, placebo-controlled trials which may eventually result in the removal of the drug from the market.
For the study in question, 700 smokers with cardiovascular disease participated in an independent randomized trial in which some of the subjects were treated with Chantix and some were treated with a placebo.
Chantix was proven to be effective in helping patients quit smoking for up to one year. But unfortunately, the subjects who received the drug experienced a higher incidence of adverse cardiovascular events that those who were provided with the placebo.
Chantix has previously been associated with a wide variety of other negative side effects, which have resulted in a ruling requiring Pfizer, the company that produces Chantix, to label the drug with restrictive "black box" warnings.
Many of these side effects are psychological and include agitation, depression, nightmares and suicidal thoughts. These symptoms have occurred in patients with no history of depression or mental illness, and those with an existing history of mental illness have experienced a worsening of their symptoms as they begin taking Chantix. These side effects have led to slow sales for what was originally believed to be a promising smoking cessation aid.
The Food and Drug Administration has been hesitant to place additional restrictions on Pfizer's production of Chantix due to the possibility that its benefits as a smoking cessation aid may outweigh the harm caused by its possible side effects.
As new evidence comes to light about the dangers of smoking, the FDA must balance the potential risk of the drug against the greater good it provides by lowering the rates of cancer and heart disease associated with smoking. But ironically, many of patients who begin taking Chantix are smokers who have developed heart problems and are interesting in smoking cessation to protect themselves from the risk of heart attacks.
Meanwhile, as they have been for generations, tobacco companies are engaged in vigorous efforts to reduce the stringency of labeling requirements on cigarette packaging and decrease restrictions on cigarette production and marketing.