(2003; 14 pages)
ACITRETIN - Warnings of depression added to label
US. Warnings of depression, aggressive feelings and thoughts of self-harm have been added to the label of acitretin (Soriatane), a product indicated in the treatment of psoriasis. These additions follow reports linking such observations with the use of the product. However, a definite causality has not been established since other factors may have contributed to some of these events. Warnings over the drug’s use in pregnancy have also been enhanced. Female patients are now required to have two negative pregnancy tests before start of therapy and must also simultaneously take two effective forms of birth control. Additionally, they must sign an agreement that they are not pregnant at start of therapy, must not get pregnant during therapy, or for three years after discontinuing treatment.
Pharma Times News Online, 9 May 2003. Available from URL: http://www.pharmatimes.co.uk