Continuous glucose monitor approved
The U.S. Food and Drug Administration (FDA) approved DexCom, Inc.'s STS Continuous Glucose Monitoring System for use in people with diabetes. Users can monitor their glucose levels and precisely dose their insulin based on the real-time information provided. The product is expected to greatly improve glycemic control. Studies show that patients using continuous glucose monitors spend 26% more time in normal glucose range and have statistically significant improvements in hemoglobin A1C levels.
The device reads glucose levels on a minute-by-minute basis using a small sensor that is inserted under the skin, which transmits data to a handheld device. An STS receiver processes the glucose signal, and with the push of a button, displays the patient's current glucose value, as well as 1-hour, 3-hour, and 9-hour trends. The receiver also sounds an alert when a high or low glucose excursion is detected.
Source: DexCom, Inc. The DexCom STS System. Available at: http://www.dexcom.com. Accessed June 10, 2006.
MAOI patch treats depression
The first transdermal patch for use in treating major depression has been approved by the FDA. Selegiline (Emsam) is a once-daily patch that delivers selegiline, a monoamine oxidase inhibitor (MAOI). Selegiline was initially approved in capsule form for use in Parkinson's disease.
The patch will be made available in three sizes that deliver 6, 9, or 12 mg of selegiline per 24 hours. The lowest dose of the MAOI patch can be used without the dietary restrictions that are needed for all oral MAOIs that are approved for treating major depression. For the other strengths, food effects can't be ruled out, so patients receiving higher doses should follow dietary restrictions that advise them to avoid certain foods and beverages, including beer, aged cheese, and wine.
Drug labeling advises users not to expose the patch to direct heat.
The only common side effect associated with Emsam in clinical trials was a mild skin reaction where the patch was placed. A less common side effect was light-headedness related to a drop in blood pressure.
Like all approved antidepressants, this product has a warning of increased suicidal tendencies in children and adolescents.
Source: FDA. FDA approves Emsam (selegiline) as first drug patch for depression. Available at: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01326.html. Accessed June 10, 2006.
Promethazine linked to respiratory depression in children
The FDA sent out an alert warning all caregivers not to administer promethazine to children under the age of 2. Promethazine, sold under the brand name Phenergan and also used in generic formulations, is prescribed in the treatment of hypersensitivity reactions, as well as for its antiemetic and sedative properties. The FDA has received reports of 7 deaths and 22 cases of respiratory depression, all related to use of promethazine in extremely young patients. All products containing promethazine are contraindicated for children younger than 2 years, and should only be used with caution for other pediatric patients. Caregivers are advised to administer the lowest effective dose for children 2 years and older, and to avoid concurrent use of any other drugs that may cause respiratory depression.
Source: Waknine Y. Promethazine products contraindicated in children under 2 years. Medscape. Available at: http://www.medscape.com/viewarticle/530795. Accessed June 1, 2006.
Drug receives new regimen
The FDA approved less restrictive hepatic monitoring guidelines for tolcapone (Tasmar) tablets, allowing for less frequent liver function monitoring for patients taking the drug, and the continuation of therapy until liver enzyme levels exceed twice the upper limit of normal.
The new regimen allows serum alanine aminotransferase and aspartate aminotransferase levels to be measured every 2 to 4 weeks during the first 6 months of therapy, then periodically at clinically relevant intervals. The schedule should be reinitiated on dose up-titration to 200 mg three times daily.
The previously approved schedule called for liver function tests to be performed every 2 weeks for the first 6 months of therapy, every 4 weeks for the next 6 months, and every 8 weeks thereafter.
Tolcapone is approved as an adjunctive treatment to levodopa and carbidopa for the treatment of idiopathic Parkinson's disease.
Source: Waknine Y. FDA approvals: Zegerid Chewable, OsmoPrep, Tasmar. Available at: http://www.medscape.com/viewarticle/528790. Accessed June 10, 2006.