May/June 2006

FDA Advances Federal E-Health Effort

The U.S. Food and Drug Administration (FDA) recently announced its federal effort to create electronic health records for Americans within the next decade by making it easier to share drug information electronically. FDA is moving the effort forward by adopting the Systematized Nomenclature of Medicine (SNOMED) as the standard computerized medical vocabulary system to be used to electronically code important terms in the Highlights section of prescription drug labeling. This move will allow healthcare professionals nationwide electronically to access and share critical health and treatment information more easily and efficiently.

To read more go to: www.fda.gov/bbs/topics/NEWS/2006/NEW01361.html

March/April 2006

FDA Issues AcuDial Diastat Advisory Letters

Valeant Pharmaceuticals recently introduced new dosing versions of Diastat, marketed as Diastat AcuDial. Diastat AcuDial is indicated for rectal administration in the management of patients with refractory epilepsy, on stable regimens of anti-epileptic drugs, who require intermittent use of diazepam to control bouts of increased seizure activity. The product is packaged as twin packs (two syringes in a package), with adjustable dosages set and locked by the pharmacist. Valeant Pharmaceuticals has received complaints of cracks at the base of the plastic tip for both the 10 mg and 20 mg product twin-packs. They are now advising doctors, pharmacists, and caregivers that small cracks have been found at the base of some of the plastic AcuDial applicators.

Below are links to all three advisory letters issued by Valeant Pharmaceuticals.

• AcuDial Pharmacist Letter
• AcuDial Physician Letter
• AcuDial Caregiver Letter