(2003; 14 pages)
LINDANE - Additional warnings and medication guide added to label
USA. The US FDA has issued a Public Health Advisory concerning the use of topical formulations of lindane lotion or shampoo for the treatment of scabies and lice, which announces significant updates to the product labelling. The labelling changes include the addition of a new boxed warning which emphasises that lindane is only indicated as a second-line treatment for scabies and lice in patients who are intolerant of, or unresponsive to, other therapies. It also provides updated safety information regarding the potential risks of adverse effects associated with use and misuse of the products, and states that lindane lotion or shampoo is contraindicated in premature infants, is not recommended for use in infants and should be used with caution in patients who weigh less than 50kg (110 pounds). The new warning also advises practitioners that, if itching continues after a single treatment, reapplication of lindane lotion or shampoo is not appropriate. The advisory states that lindane packaging sizes will be limited to 1 and 2 ounces to minimise the potential for patients to apply the product in excess and to minimise reapplication, and that pharmacists should only dispense sufficient lindane for a single application (< 2 fluid ounces). A medication guide informing patients of the risks associated with lindane products and providing instructions for the appropriate use of the drug must now be dispensed by the pharmacist with each new prescription.
FDA Talk Paper, 28 March 2003. Available from URL: http://www.fda.gov