United States of America. The Food and Drug Administration has approved for marketing Actiq, a new product developed specifically for cancer patients with severe pain that breaks through their regular narcotic therapy. Actiq is a dosage form of fentanyl citrate, an opioid narcotic, in the form of a flavoured sugar lozenge that dissolves in the mouth while held by an attached handle.
While Actiq is an effective treatment for breakthrough cancer pain, it is not without risk. Because Actiq may be fatal to children (as well as to adults not already taking opioid narcotics), the FDA approved Actiq under special regulations that restrict distribution as defined in a comprehensive risk management plan.
The most common reported side effects were sleepiness, dizziness, nausea and constipation.
Because of the uniqueness of the dosage form and because fentanyl is a potent Schedule II narcotic, the FDA advisory committee members and the Agency were extremely concerned that this product be packaged and marketed to minimize the opportunity for diversion, abuse or access by children.
References: FDA Talk Paper T98-78 dated 5 November 1998.