FDA actions

FDA actions

The FDA is warning against the use of terbutaline for prevention or prolonged treatment of preterm labor in pregnant women. The drug, which is approved for treatment of asthma, has been used off label for treatment of preterm labor and uterine hyperstimulation; however, the agency has received postmarketing reports of serious adverse reactions, including heart problems, and even maternal deaths, associated with the drug. The FDA has added a Boxed Warning and Contraindication to the labeling of the drug warning against these uses. This extends to both the IV and oral forms of terbutaline.

The FDA has approved hydroxyprogesterone caporate injection to reduce the risk of preterm delivery before 37 weeks of pregnancy in a pregnant woman with a history of at least one spontaneous preterm birth. The drug is not intended for use in women with a multiple pregnancy, such as a twin pregnancy, or other risk factors for preterm birth. The drug was approved under the FDA's accelerated approval regulations, and, as such, additional studies will be required after approval to show that the drug does indeed have clinical benefit. Hydroxyprogesterone caproate is given once a week by injection into the hip beginning at week 16 and no later than week 21. The drug is marketed by Hologic Inc. as Makena.

The FDA has issued a drug safety alert regarding the risk of serious liver injury with dronedarone (Multaq). The drug which is approved for prevention of atrial fibrillation/flutter has been associated with multiple cases of severe liver injury, including two cases that required liver transplantation. Dronedarone previously was found to double the risk of death in patients with severe heart failure and was approved with a REMS designed to prevent its use in that patient population. Physicians are reminded to advise patients to contact a health care professional immediately with any signs of hepatic injury or toxicity. All patients on dronedarone should get periodic hepatic serum enzymes especially during the first 6 months of therapy.

The FDA has approved a new treatment for head lice. Spinosad is an insecticide originally derived from a naturally occurring soil bacterium. The 0.9% topical suspension was shown to be effective in two Phase 3 active-control, randomized studies in which 86% of patients treated with the active drug were lice free after 14 days compared to 44% of controls. The product should not be used in children under 6 months of age because it contains benzyl alcohol. Spinosad is applied as a single 10-minute application which may be repeated in one week if lice are seen. It will be marketed by ParaPro LLC as Natroba.