title: Drugs and Diseases Interacting with Cigarette Smoking in US Prescription Drug Labelling.
abstract: The US Food and Drug Administration (FDA) draft guidance for industry on drug interaction studies recommends, but does not mandate, that both cigarette smokers and non-smokers can be used to study drug metabolism in clinical trials, and that important results related to smoking should be included in drug labelling to guide medication usage. This study aimed to provide a comprehensive review of drugs or diseases interacting with smoking, as presented in all US drug labelling. The 62,857 drug labels deposited in the FDA Online Label Repository were searched using the keywords 'smoke', 'smoker(s)', 'smoking', 'tobacco' and 'cigarette(s)' on 19 June 2014. The resultant records were refined to include only human prescription drug labelling, for manual examination. For 188 single-active-ingredient drugs and 36 multiple-active-ingredient drugs, the labelling was found to contain smoking-related information. The pharmacokinetics of 29 and 21 single-active-ingredient drugs were affected and unaffected, respectively, by smoking. For the remaining drugs, the provided information related to smoking affecting efficacy, safety or diseases but not pharmacokinetics. Depending on the nature of specific drugs, the perturbation in pharmacokinetic parameters in smokers ranged from 13 to 500%, in comparison with non-smokers. Dosage modifications in smokers are necessary for four drugs and may be necessary for six drugs, but are unnecessary for seven drugs although the pharmacokinetic parameters of four of them are affected by smoking. Cigarette smoking is a risk factor for 16 types of diseases or adverse drug reactions. For one single-active-ingredient contraceptive drug and 10 multiple-active-ingredient contraceptive drugs, a black box warning (the FDA's strongest safety warning) is included in the labelling for increased risks of heart attacks and strokes in female smokers, and "women are strongly advised not to smoke" when using these drugs. This study presents the first comprehensive overview of cigarette smoking interacting with drugs and/or diseases, as presented in US drug labelling.
authors.affiliation: Department of Microbiology, Nantong Center for Disease Control and Prevention, 189 South Gongnong Road, Nantong, 226007, Jiangsu, China.
authors.forename: Haibo
authors.initials: H
authors.lastname: Li
authors.forename: Qiang
authors.initials: Q
authors.lastname: Shi
mesh_terms: D000367:Age Factors; D004305:Dose-Response Relationship, Drug; D004347:Drug Interactions; D004348:Drug Labeling / Q000592:standards*; D006801:Humans; D055553:Prescription Drugs / Q000493:pharmacokinetics*; D012907:Smoking / Q000009:adverse effects* / Q000378:metabolism*; D016540:Smoking Cessation / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D055553:Prescription Drugs