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Transdermal microneedles are regularly advocated as a much safer alternative to conventional hypodermic injections and an ever increasing range of systems are being developed. While there are clear advantages to their adoption, there are a number of safety issues that are emerging which have short and long term implications for patients, clinicians, healthcare administrators and regulators. A brief overview of microneedle design is presented and considered in a critical light in comparison to conventional drug delivery routes. The focus is not on drug safety but rather on the safety concerns of the actual delivery processes for patient and healthcare practitioner. The safety benefits that these new approaches offer and the potential safety concerns that still need to be addressed are highlighted and the possible implications critically assessed.

Microneedle drug delivery systems: Appraising opportunities for improving safety and assessing areas of concern