Germany. The Medicines Committee of the German Pharmaceutical Association has made recommendations about the long-term use of minocycline for the treatment of acne vulgaris after reports were received of hepatotoxicity associated with this product, including hepatitis (27 reports), liver cell damage (8), hepatic cholestasis (1), icterus (7), lupus erythematosus (11) and lung infiltration (3). An immunoallergic potential of minocycline has also been observed especially after long- term treatment of up to six months. Symptoms include fever, lymphomadenopathy and eosinophilia prior to development of hepatitis.
The recommendations are as follows:
• When long-term therapy is envisaged (more than 21 days), liver function monitoring, blood profile and kidney examination should be performed at the initiation of treatment and at regular intervals thereafter.
• The long-term treatment of acne with minocycline should be limited whenever possible to a maximum of six months.
• Treatment for longer than six months should only be undertaken if efficacy is satisfactory and with monitoring of liver and kidney function and blood profile.
• In patients with liver dysfunction, long- term therapy with tetracycline derivatives should not be initiated.
• When possible, topical therapy with antibiotics (e.g. erythromycin, clindamycin, tetracycline) should be taken into consideration.
Reference: Pharmazeutisches Zeitung 144(19): 1530 (1999).