First in New Class of Diabetes Drugs
The FDA has approved Merck's sitagliptin (Januvia), the first diabetes treatment in a new class of drugs known as dipeptidyl peptidase IV inhibitors, which enhance the body's ability to lower blood glucose.
The drug is indicated for use in addition to diet and exercise to improve blood glucose levels in patients with type 2 diabetes. The drug is approved for use alone or in combination with metformin or a peroxisome proliferator-activated receptor gamma (PPAR) agonist when either of these drugs alone (along with diet and exercise) fail to provide adequate control of blood glucose.
In clinical trials of over 2,700 patients with type 2 diabetes, sitagliptin was shown to improve blood glucose control when used alone or in patients not satisfactorily managed with metformin or PPAR agonists. Sitagliptin has been demonstrated to provide a 24-hour glucose response at meal time, between meals, and overnight.
The most common side effects were upper respiratory tract infection, sore throat, and diarrhea.
Flu Vaccine for Adults Approved
GlaxoSmithKline's trivalent, inactivated split-virion influenza vaccine (FluLaval) has been approved for the active immunization of adults 18 years of age and over against viral strains likely to cause seasonal influenza in the northern hemisphere in 2006 to 2007.
Each 0.5-mL dose for intramuscular injection contains 15 mcg each of influenza virus hemagglutinin of A/New Caledonia/20/99 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004. The vaccine is packaged in a 10-dose vial with thimerosal (25 mcg per dose) as a preservative. The FDA approved the vaccine based on a review of data from clinical studies in 1,000 healthy U.S. adults 18 to 64 years of age and 658 Canadian adults 50 years of age and older. The vaccine was found to be safe and able to generate an immune response within 7 days of injection.
Most adverse effects related to the vaccine were mild and self-limiting. The most commonly reported were injection site pain, erythema, and/or swelling. The most commonly observed systemic adverse events were headache, fatigue, myalgia, low-grade fever, and malaise.
FluLaval should not be administered to people allergic to egg proteins, chicken proteins, or thiomersal.
Nasal Spray for Allergic Rhinitis
The FDA has approved ciclesonide (Omnaris, Altana Pharma U.S.), a new drug for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and children 12 years of age and older. Ciclesonide is a corticosteroid nasal spray.
The FDA approved the new medication based on four clinical trials demonstrating its safety and efficacy. The trials ranged from 2 weeks to 1 year. Results showed that patients treated with ciclesonide nasal spray had an 8% to 10% greater reduction in nasal symptoms (runny nose, nasal itching, sneezing, and nasal congestion) than those using a placebo.
The most common side effects in clinical trials were headache, nosebleeds, and inflammation of the nose and throat linings.
Changes Made to iPLEDGE Program
Healthcare professionals and patients have been notified of changes to the iPLEDGE risk management program designed to reduce the risk of fetal exposure to isotretinoin. The program no longer requires the 23-day lockout period for males and females of nonchildbearing potential. Previously, whether a prescription was filled or not, a patient could not start the qualification process for another prescription until 23 days after the end of their 7-day window.
The change does not affect females of childbearing potential.
Lamotrigine in First Trimester May Pose Risk
A preliminary analysis of data from the North American Antiepileptic Drug Pregnancy Registry suggests that fetuses exposed to lamotrigine (Lamictal) during the first 3 months of pregnancy may have a higher chance of being born with a cleft lip or cleft palate. The FDA notes that other pregnancy registries of a similar size have not replicated this observation, and they caution that the validity of this possible association cannot be established until further data are collected.
The FDA urges women who are pregnant and taking lamotrigine or who are thinking about taking this medication not to start or stop without first consulting their healthcare provider. The agency states that more research is needed.