Cardiovascular effects of buccal exposure to dermal nicotine patches in the dog: A comparative evaluation

Objective: Safety concerns have been raised over the possible effects of in appropriate exposure to transdermal nicotine patches. This study was initia ted to determine whether placement of these products into the mouth could a ffect cardiovascular function. Methods: In a series of 10 anesthetized beag le clogs. Nicoderm(R), Habitrol(R), ProStep(R) I (Intact), ProStep(R) D (Da maged) transdermal nicotine products or the Skoal Bandit(R) smokeless tobac co plug were placed in the buccal cavity for 5 minutes. Systemic arterial b lood pressure and the electrocardiogram were monitored for LIP to 90 minute s after exposure,vith blood samples at intervals during the first 10 minute s for plasma nicotine concentration. Results: The systolic and diastolic ar terial blood pressures and heart rate increased within 2 minutes of buccal exposure to either the intact or the damaged ProStep nicotine product. Vent ricular arrhythmias were observed in 6 of 10 dogs exposed to the intact pat ch and 7 of 10 dogs exposed to the damaged patch during the period of maxim al cardiovascular response. Modest increases in systemic blood pressure and heart rate were seen with the Nicoderm and Habitrol products but not with the Skoal Bandit. The increases in systemic arterial pressure and heart rar e occurring after exposure to ProStep were significantly more severe than t hose observed after Nicoderm and Habitrol. Mean peak nicotine levels of 9.8 mug/mL (ProStep 1), 5.4 mug/mL (ProStep D), 3.4 mug/mL (Habitrol), 2.5 mug /mL (Nicoderm), and 0.12 mug/mL (Skoal Bandit) were detected within 2 to 10 minutes after buccal placement of the product. Conclusions: Certain transd ermal nicotine patches, when applied to a nondermal site such as the buccal cavity for a short period (5 minutes) can rapidly provoke significant card iovascular alterations (hypertension, tachycardia, and ventricular arrhythm ias). The magnitude of the cardiovascular responses occurring after buccal exposure to a product of the cardiovascular responses occurring after bucca l exposure to a product such as ProStep could pose a risk to susceptible in dividuals.