New Indication for Abilify in Youths
The FDA has approved the use of aripiprazole (Abilify) for the acute treatment of manic and mixed episodes associated with bipolar I disorder, with or without psychotic features, in pediatric patients 10 to 17 years of age. Aripiprazole, a dopamine partial agonist, was previously approved to treat bipolar disease in adults.
The approval is based on the results of a 4-week clinical study of aripiprazole in 296 pediatric patients with bipolar I disorder, which showed the drug was effective compared with placebo on the mean change from baseline to week 4 on the Young-Mania Rating Scale (Y-MRS) Total Score.
Aripiprazole is taken once daily with or without food and is available in 2-, 5-, 10-, 15-, 20-, and 30- mg strengths. The recommended oral target dose in pediatric patients is 10 mg/day. The medication is also available in orally disintegrating tablets, nonrefrigerated oral solution, and intramuscular injection.
The most commonly observed adverse events associated with aripiprazole in pediatric patients were somnolence, extrapyramidal disorder, fatigue, nausea, akathisia, blurred vision, salivary hypersecretion, and dizziness.
Consult product labeling for detailed dosing information.
New Antihistamine Approved
Levocetirizine dihydrochloride (Xyzal) 0.5 mg/mL oral solution has been approved for relief of symptoms associated with allergic rhinitis (seasonal and perennial) as well as the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria. A tablet version of the medication was approved in 2007; both formulations are now approved for use in adults and children 6 years and older. UCB and Sanofi-Aventis comarket the medication.
Clinical studies in allergic rhinitis patients showed levocetirizine significantly reduced the symptoms of sneezing, itchy nose, runny nose, and itchy eyes. Studies in chronic idiopathic urticaria patients showed the drug significantly reduced the severity of itching and the number and size of the wheals.
In clinical trials, the most common adverse reactions in pediatric patients were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis.
Nationwide Recall of Duragesic Patches
PriCara announced a nationwide recall of all lots of its 25-mcg/hr fentanyl transdermal system (Duragesic) CII patches sold in the United States because the patches may have a cut along one side of the drug reservoir within the patch, which may result in the possible release of fentanyl gel from the reservoir into the pouch in which the patch is packaged. Sandoz Inc. is voluntarily recalling all of its 25-mcg/hr fentanyl patches from wholesalers and pharmacies as a precaution.
The FDA states that patches with the cut edge should not be used. Recalled patches have an expiration date on or before December 2009 and are all manufactured by ALZA Corporation. The cut edge in affected pouches can be seen upon opening the sealed foil pouch that holds the patch.
For more information, visit http://www.duragesic.com. Those with recalled patches from PriCara (Duragesic) should call 1-800-547-6446. Those with recalled Sandoz patches should call 1-800-901-7236.
Liquid Leukine Withdrawn from Market
The FDA and Bayer have notified healthcare professionals that the current liquid formulation of the growth factor Leukine was removed from the market because of an upward trend in spontaneous reports of adverse reactions, including syncope, that are temporarily correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized Leukine, the FDA notes.
Healthcare professionals are instructed to immediately stopping using the liquid Leukine formulation and return unused vials to the manufacturer. Bayer will establish a special access program for the currently marketed lyophilized Leukine 250 mcg vial, which does not contain EDTA. The program is designed to prioritize the supply of lyophilized Leukine for oncologists and hematologists who prescribe Leukine.