FDA Rounds

First Once-Monthly Injectable for Alcohol Dependence

Naltrexone extended-release (ER) injectable suspension (Vivitrol; Alkermes/ Cephalon) has been approved for the treatment of alcohol dependence in persons attempting to stop their dependence. It is the first and currently only once-monthly injectable agent approved for persons who are able to abstain from drinking in an outpatient setting. It should only be used in persons not actively drinking at the time of therapy initiation. Naltrexone ER will be available as a single-dose, 380-mg intramuscular injection and is intended to be used in combination with psychosocial support, such as counseling or group therapy. Side effects include nausea, vomiting, headache, dizziness, fatigue, and injection-site reactions (www.vivitrol.com).

Transdermal Patch for ADHD

A once-daily transdermal patch formulation of methylphenidate, the methylphenidate transdermal system (Daytrana; Shire), has been approved for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children aged >6 years. The patch will be available in 10-, 20-, and 30-mg dosage strengths. Adverse events include decreased appetite, insomnia, nausea, vomiting, weight loss, tics, and emotional lability (www.shire.com).

New Glucose Monitoring System

The MiniMed Paradigm Real-Time Insulin Pump and Continuous Glucose Monitoring System (Medtronic) has received approval. The system relays a glucose reading every 5 minutes from a glucose sensor to the insulin pump, which displays up to 288 readings per day, providing nearly 100 times more information than 3 daily fingersticks (www.minimed.com).

FDA Responds to Claims About Benzene in Soft Drinks

IMWR

In response to reports of possible benzene contamination in some soft drinks (see , March 2006), the FDA announced that a recent analysis indicates that the vast majority of soft-drink beverages sampled contained either no detectable benzene or levels that were well below 5 parts per billion US water standard“--”the legal limit for drinking water. These data come from a new survey conducted by the FDA’s Center for Food Safety and Applied Nutrition that began after claims were made in November 2005 that benzene had been detected at low levels in some soft drinks containing benzoate salts (an antimicrobial agent) and ascorbic acid, particularly under certain conditions of storage, shelf life, and handling (www.fda.gov).

SNOMED: One Step Closer to Electronic Medical Records

As part of the ongoing federal effort to create electronic health records, the FDA has adopted the Systematized Nomenclature of Medicine (SNOMED) as the standard computerized medical vocabulary for electronically coding important terms in the “Highlights” section of prescription drug labeling. Specifically, the FDA is adopting the “Problem List” subset of SNOMED for use in this electronic labeling initiative. This subset of SNOMED that can electronically code certain items in the “Highlights” data elements of the new format for prescription drug information will be required beginning June 30, 2006, for all recently approved (ie, within the past 5 years) and newly approved medications (www.fda.gov).