New indication for Abilify in youths
[black small square] The FDA has approved the use of aripiprazole (Abilify) for the acute and maintenance 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
[black small square] 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.
New Tekturna HCT tablet approved
[black small square] The FDA has approved Novartis's aliskiren-hydrochlorothiazide (HCTZ) combination tablet, Tekturna HCT, for the second-line treatment of hypertension. The tablet is approved for patients not controlled by either drug alone, but should not be used before other medications have been tried.
Tekturna HCT may be given with other antihypertensives in combination with medications for other conditions such as high cholesterol or diabetes. It can also be taken with or without food.
According to Novartis, Tekturna is the only medication to directly target renin. Tekturna HCT is available in four tablet strengths containing aliskiren-HCTZ: 150 mg/12.5mg, 150 mg/25 mg, 300 mg/12.5 mg, and 300 mg/25 mg. The most common side effects experienced by patients taking the new combination medication included dizziness, flu-like symptoms, diarrhea, cough, and tiredness.
FDA acts against menopause drugs
[black small square] The FDA sent warning letters to seven pharmacy operations concerning claims they made about the safety and effectiveness of their so-called "bioidentical hormone replacement therapy" (BHRT) products. According to the FDA, these claims are unsupported by medical evidence and are considered false and misleading by the agency.
The BHRT drugs sold by these pharmacies contain hormones such as estrogen, progesterone, and estriol; the pharmacies claim that they are superior to FDA-approved menopausal hormone therapy (HT) drugs and can prevent or treat serious diseases. The agency is concerned that unfounded claims like these mislead women and healthcare professionals. "Compounded drugs are not reviewed by the FDA for safety and effectiveness, and the FDA encourages patients to use FDA-approved drugs whenever possible," the agency's statement notes. The FDA has never approved any drug product containing estriol, and the safety and effectiveness of estriol is unknown.
The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their HT drugs.
New beta-blocker approved for hypertension
[black small square] Forest Laboratories and Mylan announced the approval of nebivolol (Bystolic), a new beta-blocker for the once-daily treatment of hypertension. Nebivolol can be used alone or in combination with other hypertension treatments.
At doses less than or equal to 10 mg/day, the medication is a selective beta1-blocker and has the added pharmacologic properties of producing vasodilation and reducing total peripheral resistance.
Nebivolol was well tolerated in clinical trials, with a low incidence of side effects traditionally associated with beta-blockers. Headache, fatigue, and dizziness were the most commonly reported side effects.
Nebivolol should not be combined with other beta-blockers. Refer to product labeling for detailed prescribing information.
Nationwide recall of duragesic patches
[black small square] 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 they 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.