FDA rejects lindane ban petition

Created on 13.12.12

A petition requesting that lindane be withdrawn from sale as a second-line pediculicide has been denied by the US Food and Drug Administration (FDA).

The petition, filed in June 2010, requested that the FDA withdraw approval from lindane in its role as a second-line pediculicide (where intial head lice treatments have proven ineffective) and that lindane be withdrawn from the market. The petition was supported by a letter from a member of the US House of Representatives in May 2012.

The FDA judged that there was insufficient new evidence to merit a change in the risk-benefit profile for patients who require second-line lice treatments. They note in their response than lindane only accounted for 2% of the prescription pediculicide and scabicide market in the US.

Further, instances of adverse reaction to lindane treatment have also declined markedly since 2003, when the health advisory data regarding lindane was revised and strengthened. They conclude that 'there is a public health value to have multiple treatment options available [for pediculosis].' 




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