B Lebrun-Vignes1, C Kreft-Jais, A Castot, O Chosidow. 1. Regional Center of Pharmacovigilance, Department of Pharmacology, Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris, 47-83 boulevard de l'Hôpital, 75651 Paris Cedex 13, France. benedicte.lebrun-vignes@psl.aphp.fr
Abstract
BACKGROUND: The question of quantitative and qualitative differences between adverse drug reactions (ADRs) to tetracyclines was raised many years ago, especially for minocycline and doxycycline. OBJECTIVES: To assess and compare ADRs related to tetracyclines according to sales figures in France through a national survey. METHODS: ADR data were collected from the French Pharmacovigilance Database (FPD), marketing authorization holders (MAH) and the literature. Sales analyses were based on MAH data provided annually to the French Drugs Agency. RESULTS: Among the tetracyclines available in France, doxycycline and minocycline are the most frequently used. However, their sales decreased between 1995 and 2007, more sharply for minocycline than doxycycline. According to the FPD, based on MAH data and published reports, minocycline-associated ADRs were more serious and were reported more frequently than for the other tetracyclines. Minocycline and doxycycline ADR patterns differed: gastrointestinal disorders (especially oesophageal lesions) predominated with doxycycline, while intracranial hypertension and hepatic disorders were primarily reported with minocycline. Autoimmune disorders, drug reaction with eosinophilia and systemic symptoms (DRESS) and other hypersensitivity reactions were also more frequent with minocycline. ADRs reported with lymecycline and metacycline were essentially cutaneous and gastrointestinal disorders. CONCLUSIONS: In the absence of markedly better efficacy against the various indications for tetracyclines, the minocycline benefit/risk ratio was clearly lower than that of doxycycline, and possibly those of lymecycline and metacycline. In light of these findings, minocycline should no longer be considered first-line therapy for inflammatory skin disorders, especially acne.
BACKGROUND: The question of quantitative and qualitative differences between adverse drug reactions (ADRs) to tetracyclines was raised many years ago, especially for minocycline and doxycycline. OBJECTIVES: To assess and compare ADRs related to tetracyclines according to sales figures in France through a national survey. METHODS: ADR data were collected from the French Pharmacovigilance Database (FPD), marketing authorization holders (MAH) and the literature. Sales analyses were based on MAH data provided annually to the French Drugs Agency. RESULTS: Among the tetracyclines available in France, doxycycline and minocycline are the most frequently used. However, their sales decreased between 1995 and 2007, more sharply for minocycline than doxycycline. According to the FPD, based on MAH data and published reports, minocycline-associated ADRs were more serious and were reported more frequently than for the other tetracyclines. Minocycline and doxycycline ADR patterns differed: gastrointestinal disorders (especially oesophageal lesions) predominated with doxycycline, while intracranial hypertension and hepatic disorders were primarily reported with minocycline. Autoimmune disorders, drug reaction with eosinophilia and systemic symptoms (DRESS) and other hypersensitivity reactions were also more frequent with minocycline. ADRs reported with lymecycline and metacycline were essentially cutaneous and gastrointestinal disorders. CONCLUSIONS: In the absence of markedly better efficacy against the various indications for tetracyclines, the minocycline benefit/risk ratio was clearly lower than that of doxycycline, and possibly those of lymecycline and metacycline. In light of these findings, minocycline should no longer be considered first-line therapy for inflammatory skin disorders, especially acne.
Authors: Sarah E Garner; Anne Eady; Cathy Bennett; John Norman Newton; Karen Thomas; Catalin Mihai Popescu Journal: Cochrane Database Syst Rev Date: 2012-08-15
Authors: José Tiago Silva; Francisco López-Medrano; Mario Fernández-Ruiz; Elena Resino Foz; Aránzazu Portillo; José A Oteo; José Maria Aguado Journal: Emerg Infect Dis Date: 2015-12 Impact factor: 6.883