There appear to be new safety concerns for Chantix, Pfizer Inc.’s smoking-cessation drug, and that’s not good for the company. These developments could hurt the already stumbling sales acceleration of Chantix and will likely lead to legal problems for the pharmaceutical giant. A recent report from a watchdog group suggested Chantix may be linked to problems such as heart trouble, seizures and diabetes, adding to the already-known connection to psychiatric problems including suicide and depression. These safety and health concerns are not to be taken lightly.

The large number of adverse reactions in the study published recently by the Institute for Safe Medication Practices (ISMP) adds new urgency to the previous safety concerns Public Citizen and others had about Chantix. It also highlights the dangerous inadequacy of the response of Pfizer and the Food and Drug Administration to the rapidly increasing number of serious, life-threatening adverse events seen with this drug. In September 2007, Dr. Sidney Wolfe, Director of the Health Research Group at Public Citizen, warned in the publication Worst Pills, Best Pills News (online at WorstPills.org) that people should not use Chantix until the year 2014. This reflects the inadequate amount of information about the safety of Chantix and concerns raised by the increased amount of adverse psychiatric events that occurred in the randomized trials preceding its approval. In one of the studies, 6.8% of patients using Chantix had adverse psychiatric events as opposed to only 2.4% of those given a placebo. In the May 2008 issue of the British Drug and Therapeutics Bulletin (DTB), the authors stated:

We are concerned about reports of psychiatric problems with this drug. Given such concerns, marketing claims of a ‘favourable safety and tolerability Profile’ are questionable.

The ISMP study of 173 serious reports of accidents and injuries, including 28 road traffic accidents, calls for a much stronger warning than in the recently revised new labeling and new patient medication guide for the drug (revised May 16). Dr. Wolfe says the new label inadequately states that “[p]atients should be advised to use caution driving or operating machinery until they know how quitting smoking with Chantix may affect them.” The inadequacy of this “use caution” warning is further emphasized by the statement in the label that there were, in clinical trials with Chantix, “Frequent: Disturbance in attention, Dizziness, Sensory disturbance.” None of these are compatible with safely driving (cars, buses, trains or planes) or operating machinery. Instead, we agree with the advice this week in the DTB that “Patients taking varenicline should, therefore, be advised not to drive or operate machinery [emphasis added] until they know whether the drug will impair their ability to do so.” In addition to the warning against driving, Dr. Wolfe and Public Citizen also urge that the FDA take the following actions:

Require a black box warning about the adverse effects including warning against driving as discussed above, the adverse psychiatric effects such as suicidal thoughts or actions, depression and agitation and serious adverse skin reactions;

Require Pfizer to immediately send a dear doctor letter warning about these adverse effects;

Require Pfizer to significantly strengthen the warning language in the label and patient medication guide.

There should be little doubt as to whether Chantix is a dangerous drug. Neither should there be any doubt about the capacity of the FDA to adequately protect the public because it can’t. The FDA is controlled by the drug industry and is inadequately funded by Congress.

Source: Public Citizen

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