FDA action related to medication safety and reliability, labeling, September 2007

Key Points

FDA is permitting restricted use of tegaserod (Zelnorm, Novartis) under a treatment investigational new drug (IND) protocol for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women aged <55 years who meet specific guidelines. All patients being treated with tegaserod must sign consent forms indicating that they are fully informed of the potential risks and benefits of this agent.

At a joint meeting of FDA's Dermatologic and Ophthalmic Drugs and Drug Safety and Risk Management advisory committees, panelists recommended that the current restricted distribution program for isotretinoin (known as iPledge), which was developed to reduce the number of pregnancies occurring during isotretinoin treatment, should be made more flexible in order to reduce interruptions in treatment. Currently, women of childbearing potential must have 2 negative pregnancy tests before beginning treatment, a negative pregnancy test every month during treatment, and a negative pregnancy test 1 month after stopping treatment; if prescriptions are not filled within 7 days of the office visit, patients must wait 23 days before receiving the medication. Panelists recommended that the 7-day window for obtaining the medication should instead begin on the day of the pregnancy test. Panelists also recommended that men and women not of childbearing potential should have a 30-day window for filling prescriptions.