Dermatologists report Accutane problems

The US Food and Drug Administration's on-line tracking database iPledge, to which all patients using Swiss drug major Roche's acne remedy, Accutane (isotretinoin), have to be registered in the USA in order to receive the drug, has caused problems for 90% of dermatologists, according to a survey.

The research was carried out on behalf of the American Academy of Dermatology. Because of severe side effects in pregnant women, the FDA issued guidelines which require that women submit two negative pregnancy tests before receiving their initial prescription for Accutane. Additional restrictions include the requirement that women undergo further pregnancy test before each refill application and strict limits on the dates of the month when the drug can be supplied.

The dermatologists surveyed reported problems with the administration of iPledge, reinforcing the AAD's previous view that the scheme's adoption was premature.