What Is Champix?
Due to a decision by the European Commission, many smokers in the European Union have started asking, “What is Champix?” Due to a decision by the Food Drug Administration (FDA), smokers in the United States have no reason to ask, “What is Champix?” Instead, some of them are asking, “What is chantix?”
Ironically, both champix and chantix contain the same active ingredient. Both drugs use varenicline to help smokers wean off of their dependence on cigarettes. Why does the presence of the Atlantic Ocean create two very different responses to the same drug?
The European Commission and the FDA examined results from the same series of clinical trials, trials conducted by Pfizer Pharmaceuticals. As the maker of a drug with varenicline, Pfizer wanted to prove that the drug treated nicotine dependence in an efficacious and safe manner. The FDA and the European Commission seem to have viewed the same results through different glasses.
Those results convinced the FDA that they could allow marketing of Pfizer’s varenicline tablets in the U.S. Yet those results also cautioned the FDA about allowing the presence of a drug that would invite the question “What is Champix?” The FDA did not miss the fact that the word “champ” was in the word “champix.”
The FDA felt less than convinced that creators of the Pfizer drug with varenicline had championed the contest to create a drug that would prevent large numbers of smokers from reverting to dependence on a dangerous habit. The FDA indicated in its report that it did not feel comfortable encouraging smokers to ask, “What is Champix?” The FDA suggested that such a name implied greater benefits than the results proved possible.
To the credit of the scientists at Pfizer, it should be noted that an incident that took place forty years ago might relate to some information on one side effect experienced by participants in the Pfizer trials. That incident, an incident not mentioned in any medical report, mirrors a complaint stated in at least two online articles about champix and chantix. That incident concerned a patient’s experience with an abnormal dream.
Some recent participants in the Pfizer trials reported having “abnormal dreams” while taking the tablets with the varenicline. The articles do not indicate how often those participants had abnormal dreams. Forty years ago, a patient getting a series of weekly allergy shots found that she had abnormal dreams on two succeeding weeks. She continued with the shots, and she never had a return of such injection-associated dreams.
Did the mention of abnormal dreams make the FDA slow to OK a name that would have smokers asking “What is Champix?” If so, then perhaps Pfizer would have had a stronger case for that name, if their PR person had been aware of the above incident. Of course their PR person did not have access to information on an unreported incident. Consequently, Pfizer chose to put its varenicline tablets in bottles labeled “chantix,” whenever those bottles would go on store shelves in the United States.
