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Minocycline has been licensed for over 35 years for a wide range of bacterial infections (a Summary of Product Characteristics [SPC] lists 16 indications) including respiratory, genitourinary and skin conditions.1,2 However, much of its popularity has been for its use in treating acne. Minocycline was associated with claims that it was “more effective, less likely to cause bacterial resistance and easier to take than other tetracyclines”.3 In addition, the availability of an adherence-friendly, once-daily, modified-release preparation and a lack of restriction when taken with food or ‘moderate amounts of milk’, quickly made it a favourite with general practitioners and patients. It became particularly popular for use for teenagers with acne, a group notorious for non-adherence and for whom a single daily dose was seen as an advantage. Between 1997 and 2006 about 500,000 prescriptions for minocycline were dispensed each year in England, accounting for about one third of all tetracycline prescriptions by volume and two thirds by cost.4 Partly as a result of concerns over its safety, the amount of minocycline prescribed has fallen by about two thirds, while the overall volume of prescribing of all tetracyclines has increased by 10%. However, given that over 100,000 prescriptions for minocycline are still issued each year, is further action required in light of the adverse effect profile of the drug?
Doubts about the safety of minocycline started in the 1990s with reports of rare but serious and apparently idiosyncratic adverse effects that included hypersensitivity reactions of eosinophilia, pneumonitis and nephritis, autoimmune hepatitis and lupus erythematosus-like syndrome.5,6 Such reactions seem to be more common with minocycline than with other tetracyclines.7 In addition, minocycline appears to be the only tetracycline that can cause potentially irreversible slate-grey pigmentation of the skin.1 The ‘Special warnings and precautions for use’ section of the minocycline SPC lists all these reactions. A Cochrane review reported that that the increase in risk of lupus was about 53 cases per 100,000 prescriptions and concluded that “patients treated with minocycline for acne are at a significantly greater risk of developing an autoimmune (lupus-like) syndrome than those given tetracycline or no treatment.”6 In contrast, minocycline does not appear to have any significant clinical advantage over other interventions for acne, with no difference in long-term outcomes, no benefit in acne that is resistant to other therapies, and no evidence that its effects last longer than other treatments.6
DTB highlighted the lack of a clinical advantage for minocycline and the potential for serious adverse effects in 2006, and suggested that it was difficult to justify its use in the management of patients with acne.3 Further publications in 2007 and 2009 reinforced the message and highlighted the availability of other once-daily tetracyclines for the treatment of acne.7,8 However, the reduction in prescribing has slowed and the volume of prescribing remains a cause for concern given the ever-present risk of avoidable harm to patients. The National Institute for Health and Care Excellence has recently highlighted minocycline in its document Key therapeutic topics—medicines management options for local implementation and recommends that clinicians “review and, if appropriate, revise prescribing of minocycline in light of its potential harms”.9 We advocate that this process needs more urgent action. We challenge medicines management committees to remove minocycline from their formularies, and prescribers to justify every prescription for this drug.
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