title: Do package inserts reflect symptoms experienced in practice?: assessment using an automated phone pharmacovigilance system with varenicline and zolpidem in a primary care setting.
abstract: BACKGROUND
  While the US FDA maintains a voluntary reporting system, postmarketing adverse drug events (ADEs) are underreported, and this case report-based system does not allow accurate determination of incidence.
  
  
  OBJECTIVE
  The aim of the study was to assess the usefulness of an automated phone pharmacovigilance system for ambulatory patients by comparing systematically collected, patient-reported symptoms to reflect possible ADEs with those reported on the package inserts of two drugs with postmarketing safety concerns, varenicline and zolpidem.
  
  
  METHODS
  English-speaking adults who received a prescription for zolpidem (n = 370) or varenicline (n = 107) from a primary care physician at one of 11 participating clinics, and who participated in the pharmacovigilance system during 2008-2010, were included in the study. Patients were called approximately 4 weeks following their visit and asked to complete a standard script that asked about adherence and pre-specified symptoms.
  
  
  METHODS
  The main outcome measures were elicited rates of pre-specified symptoms or possible ADEs.
  
  
  RESULTS
  Compared with the package insert, patients taking zolpidem were significantly (p < 0.001) more likely to report fatigue (9.0% vs 1.0%), itching (4.5% vs 1.0%) and muscle aches (5.6% vs 1.0%). Elicited rates of depression and hallucination were similar to those reported in the package insert. Patients taking varenicline were significantly more likely to report confusion (1.7% vs 0.1%), depression (3.4% vs 0.1%), fatigue (6.0% vs 1.0%), hallucinations (1.7% vs 0.1%), muscle aches (6.0% vs 1.0%) and sexual dysfunction (4.3% vs 0.1%).
  
  
  CONCLUSIONS
  Automated phone pharmacovigilance can provide estimates of possible ADEs in clinical practice. In the case of varenicline, these data support some of the safety concerns that have come to light postmarketing, while others such as depression and hallucination related to zolpidem were not detected. These data highlight the potential value of, and innovative ways of collecting, information about possible ADEs directly from patients.
authors: Division of General Medicine and Primary Care, Brigham and Womens Hospital, Boston, MA 02120, USA. jhaas@partners.org
authors: Jennifer S
authors: JS
authors: Haas
authors: Mary
authors: M
authors: Amato
authors: Lucas
authors: L
authors: Marinacci
authors: E John
authors: EJ
authors: Orav
authors: Gordon D
authors: GD
authors: Schiff
authors: David W
authors: DW
authors: Bates
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D001552:Benzazepines / Q000009:adverse effects*; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D018722:Nicotinic Agonists / Q000009:adverse effects*; D010361:Patients / Q000523:psychology; D060735:Pharmacovigilance; D011320:Primary Health Care; D011356:Product Labeling; D011725:Pyridines / Q000009:adverse effects*; D011810:Quinoxalines / Q000009:adverse effects*; D013689:Telephone; D000068580:Varenicline; D055815:Young Adult; D000077334:Zolpidem
chemical_list: D001552:Benzazepines; D006993:Hypnotics and Sedatives; D018722:Nicotinic Agonists; D011725:Pyridines; D011810:Quinoxalines; D000077334:Zolpidem; D000068580:Varenicline