What's new: newly approved drugs for children.

Abstract

1. Myles B. Abbott, MD* 2. Robert H. Levin, PharmD† 1. 2. *Private pediatric practice in Berkeley and Orinda, CA, and Clinical Professor of Pediatrics, University of California San Francisco School of Medicine, San Francisco, CA. Dr. Abbott is a consultant for Express Scripts. 3. 4. †Professor of Clinical Pharmacy, University of California San Francisco School of Medicine, San Francisco, CA. Dr. Levin has funding for two pharmacy specialty residents from Bristol-Meyers-Squibb. In 2000, the United States Food and Drug Administration (FDA) approved 160 medications and medical devices, many that have pediatric indications. We discuss eight of these medications that have clinical importance to the general pediatrician. Two of the medications are new drugs (Table 1⇓ ), three represent new delivery systems for existing drugs (Table 2), and three are new combinations of drugs (Table 3)⇓ . View this table: Table 1. Newly Approved Drugs View this table: Table 2. New Delivery Systems View this table: Table 3. New Drug Combinations ### Lantus™ Lantus (insulin glargine, Aventis, Parsippany, NJ) is a long-acting recombinant human insulin analog indicated for the management of insulin-dependent diabetes mellitus. It has a relatively constant glucose-lowering profile without peaks and valleys over 24 hours, allowing it to be administered once every 24 hours. It may be best suited as a substitute for patients receiving twice-daily intermediate-acting insulin, for those experiencing the“ dawn phenomenon” with an intermediate-acting insulin, or for those who experience hypoglycemia from intermediate- or long-acting insulins. It is approved for use in children 6 years of age and older and is administered subcutaneously, usually at bedtime. Children currently using once-daily intermediate- or long-acting insulins can be changed to the same dose of insulin administered as Lantus. When initiating therapy for children currently receiving twice-daily intermediate-acting insulin, the dose should be 80% of the total daily dose of the intermediate-acting insulin to prevent hypoglycemia. Close glucose monitoring is vital during the change in therapy. Lantus cannot be mixed with any other type of insulin, including …