New Medication Treats Hives, Allergies
The FDA approved levocetirizine (Xyzal) to treat nasal allergies and chronic hives in adults and children 6 years of age and over. Levocetirizine is a product of UCB and Sanofi-Aventis.
The new, once-daily antihistamine has been shown in clinical trials to significantly reduce sneezing, itchy nose, runny nose, and itchy eyes, and to significantly reduce the severity of itching and the number and size of wheals.
The most common adverse reactions in patients ages 12 years and over reported in clinical trials of levocetirizine were somnolence, nasopharyngitis, fatigue, and dry mouth. In pediatric patients, the most common adverse reactions were pyrexia, cough, somnolence, and epistaxis.
Levocetirizine should not be used in patients with end-stage kidney disease and in patients undergoing hemodialysis. It is also contraindicated in patients 6 to 11 years of age with impaired renal function. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination after taking levocetirizine. Concurrent use of alcohol or central nervous systems depressants should be avoided.
Tinidazole for Bacterial Vaginosis
The FDA has approved a new indication for tinidazole (Tindamax) to treat bacterial vaginosis. Tinidazole has already been approved for treatment of three other infections: trichomoniasis, giardiasis, and amebiasis.
Tinidazole is the first new oral therapy to be approved for the treatment of bacterial vaginosis in a decade. It provides a shorter-course oral treatment with fewer doses per day and improved tolerability. Tinidazole is the only approved treatment for both bacterial vaginosis and trichomoniasis.
Tinidazole is administered as 1 gram once daily for 5 days or 2 grams once daily for 2 days. It is approved for use in adult, nonpregnant women, and should be given with food.
Metallic taste and nausea are the most commonly reported adverse events associated with tinidazole.
FDA Attacks Unapproved Guaifenesin Products
The FDA intends to take action against companies that market unapproved drug products in timed-released dosage form that contain guaifenesin. The action will affect approximately 20 firms with products that have not been FDA-reviewed. The FDA considers these products to be unapproved drugs, and notes that drugs that "skirt the approval process may be unsafe, may not work, and often have inadequate labeling or are improperly manufactured."
To date, only Adams Respiratory Therapeutics has obtained FDA approval for timed-release products containing guaifenesin.
The action does not affect products containing guaifenesin in immediate-release form.
Companies marketing unapproved products containing guaifenesin in timed-release forms are expected to stop manufacturing them within 90 days and must cease shipping them in interstate commerce within 180 days.
Skin Patch Treats Early Parkinson's
The FDA has approved rotigotine transdermal system (Neupro) for the treatment of early symptoms of Parkinson's disease.
The drug is the first transdermal patch approved for the treatment of Parkinson's disease symptoms. Neupro is a dopamine agonist delivered using a silicone-based patch that is replaced every 24 hours.
The most common side effects associated with Neupro are reactions at the skin patch site, dizziness, nausea, vomiting, drowsiness, and insomnia. Other potential safety concerns associated with the drug include sudden onset of sleep while engaged in routine activities (such as driving), hallucinations, and postural hypotension.
Neupro Patch is a product of Schwarz Bioscience.