New Indications Approved for Risperidone
The FDA approved Janssen's risperidone (Risperdal) tablets for two new indications: as a treatment for schizophrenia in adolescents aged 13 to 17 years and as monotherapy for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents aged 10 to 17 years. This is the first FDA approval of an atypical antipsychotic medication to treat either disorder in these age groups.
Previously, there was no FDA-approved drug for the treatment of schizophrenia for pediatric use, and lithium was the only drug approved for the treatment of bipolar disorder in adolescents ages 12 years and up.
The efficacy of risperidone for these indications was demonstrated in clinical trials.
The most common side effects were drowsiness, fatigue, increased appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash.
Once-Yearly Osteoporosis Drug Approved
Zoledronic acid 5 mg injection (Reclast, Novartis) has been approved for the treatment of postmenopausal osteoporosis. This medication is administered as a once-yearly 15-minute intravenous infusion. Zoledronic acid injection was previously approved for treatment of Paget's disease. A 4 mg infusion of zoledronic acid (Zometa) is approved for treatment of hypercalcemia of malignancy, multiple myeloma, and bone metastases of solid tumors.
The FDA based its approval on data from a 3-year trial of the once-yearly treatment which showed that it decreased the risk for morphometric vertebral fractures by 70% and the risk for hip fractures by 41%. The reduction in spine fracture risk was sustained during the 3-year trial period. Women receiving zoledronic acid injection therapy also had significant mean increases in bone mineral density at the total hip, lumbar spine, and femoral neck relative to placebo.
Treatment with zoledronic acid injection was generally well tolerated. The most commonly reported adverse events postdose were fever, muscle pain, flu-like symptoms, headache, and bone pain that generally resolved within 3 days and decreased in incidence with subsequent doses. No spontaneous cases of osteonecrosis of the jaw were seen in this study.
Stronger Warning Added to Diabetes Drugs
Manufacturers of drugs in the thiazolidinedione class of type 2 diabetes medications have agreed to add a stronger warning about the risk of heart failure to the labeling. The upgraded boxed warning will emphasize that the drugs may cause or worsen heart failure in certain patients.
The updated warning applies to the entire class of drugs, which includes rosiglitazone (Avandia), pioglitazone (Actos), rosiglitazone-glimepiride (Avandaryl), rosiglitazone-metformin (Avandamet), and pioglitazone-glimepiride (Duetact). The FDA is concerned that the drugs are being prescribed to patients with inadequate monitoring for signs of heart failure.
Questions About OTC Cough/Cold Medicine in Children
The FDA issued a Public Health Advisory concerning the use of over-the-counter (OTC) cough/cold products in children and adverse events. The problems appear to arise when children are given more than the recommended dosage, give them too often, or give more than one product containing the same active ingredient. The agency recommended that parents carefully follow directions for use of these products as found on the package labels. Other recommendations are also provided in the advisory, which can be found at http://www.fda.gov/cder/drug/advisory/cough_cold.htm.
The FDA has plans to convene a meeting of the Nonprescription Drugs Advisory Committee to discuss the safety and effectiveness of cough/cold drug products when used by children. The agency plans to address questions about the safety of these medications and whether their benefits justify any potential risks from use in children, especially those younger than 2 years of age.