title: Manufacturer's information insert and subjective theophylline side-effects.
abstract: In Western Europe medicine packages contain an insert prepared by the manufacturer which enumerates the drug side-effects. We investigated the influence of this insert on alleged theophylline side-effects. Forty literate adult asthmatics were randomly allocated into two groups (n = 20 each): theophylline packages contained the manufacturer's insert in group A but not in group B. Theophylline was prescribed (10 mg.kg-1 body weight qd) for one week. During this period the patients filled a diary grading 13 different symptoms from 0 to 3; 5 of these symptoms were listed on the insert as theophylline side-effects. On the eighth day the patients were interviewed and theophylline blood levels measured. Theophylline side-effects were significantly more marked in group A than in group B, whereas the other symptoms were of similar magnitude. Eight patients prematurely stopped their treatment in group A vs 3 in group B, because of alleged intolerance. Theophylline blood levels did not differ significantly in the two groups; neither did they in the subgroup which stopped treatment and in the one which complied to prescription. We conclude that side-effects were suggested to the patients by the insert and/or that the insert increased their awareness of side-effects, with a subsequent detrimental influence upon compliance to therapy.
authors.affiliation: Département des Maladies Respiratoires, Centre Hospitalier et Universitaire de Marseille et UBRAC, Briançon, France.
authors.forename: D
authors.initials: D
authors.lastname: Vesco
authors.forename: M
authors.initials: M
authors.lastname: Toumi
authors.forename: F
authors.initials: F
authors.lastname: Faraj
authors.forename: H
authors.initials: H
authors.lastname: Razzouk
authors.forename: J
authors.initials: J
authors.lastname: Orehek
mesh_terms: D000328:Adult; D001249:Asthma / Q000188:drug therapy; D004348:Drug Labeling; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013806:Theophylline / Q000009:adverse effects* / Q000097:blood / Q000627:therapeutic use; D016312:Treatment Refusal / Q000523:psychology*
chemical_list: D013806:Theophylline