The risk of a neural tube defect in a baby born to a mother who took valproate or one of the two related products during the first 12 weeks of pregnancy is 1 in 20, compared with the U.S. background rate of 1 in 1,500, and the major malformation rate in babies is nearly fourfold greater with valproate than with a different antiepileptic: 10.7% vs. 2.9%.
Marketed as Depakene and as Stavzor, valproic acid was approved in 1978 for treating epilepsy. Valproate, marketed as Depacon, was approved more recently for treating bipolar disorder and migraine headaches. Divalproex sodium, marketed as Depakote, Depakote CP, and Depakote ER, is approved for migraine prophylaxis, manic episodes associated with bipolar disorder, and epilepsy.
Inhaled Antibiotic Eyed for Use in CF
Studies of an inhaled formulation of the monobactam antibiotic aztreonam in patients with cystic fibrosis show that it is a safe and effective treatment for Pseudomonas aeruginosa lung infections in this population, a federal advisory panel concluded in a 15–2 vote.
The FDA's Anti-Infective Drugs Advisory Committee found that the manufacturer, Gilead Sciences, had provided substantial evidence that inhaled aztreonam, administered at a dose of 75 mg three times a day for 28 days, was safe and effective for the proposed indication: improvement of respiratory symptoms and pulmonary function in patients who have cystic fibrosis with P. aeruginosa. If approved, the company plans to market it as Cayston, along with a novel, portable handheld nebulizer. The panel was not asked to vote specifically on whether to recommend approval.
Inhaled aztreonam has been approved for this indication in the European Union, Canada, and other countries. The intravenous formulation was approved in 1986 in the United States for indications that include P. aeruginosa infections, but not specifically for CF patients.