Antidepressant Approved for Anxiety Disorder
Eli Lilly's antidepressant duloxetine (Cymbalta) has been approved for a new indication-the treatment of generalized anxiety disorder (GAD). The safety and efficacy of duloxetine was shown in three randomized, double-blind, placebo-controlled studies in more than 800 nondepressed adults with GAD. In all studies, duloxetine significantly improved core anxiety symptoms, as measured by the Hamilton Anxiety Scale, compared with placebo. Patients in the studies who were taking duloxetine also reported greater improvement in functional impairment associated with GAD, including improved ability to perform everyday activities at work, home, and in social situations.
Duloxetine was previously approved to treat major depressive disorder and management of diabetic peripheral neuropathic pain in adults. Duloxetine is not approved for use in pediatric patients.
OTC Orlistat Promotes Adult Weight Loss
The FDA has approved an over-the-counter (OTC) formulation of orlistat (Alli) capsules for use in conjunction with a reduced-calorie, low-fat diet and exercise to reduce weight in adults. Alli is a product of GlaxoSmithKline.
The OTC 60 mg capsule of Alli is one-half of the strength available by prescription (Xenical, a product of Roche Laboratories). Alli is taken three times daily with meals containing about 30% or 15 grams of fat. Because Alli can reduce the absorption of some fat-soluble vitamins and beta carotene, patients should take a multivitamin once daily at bedtime.
Starter packs of Alli contain 60 capsules, portable references that include a booklet on weight loss tips, and a healthy eating guide. A free membership in a program to help promote weight loss and healthy eating is also included (http://www.myalli.com).
The most common side effect associated with Alli is bowel changes, including gas with oily spotting and loose stools. Eating a low-fat diet reduces the likelihood of this effect.
Alli is not recommended for patients with chronic malabsorption syndrome or cholestasis, and is contraindicated in pregnant or breastfeeding women, and in patients who have had an organ transplant or are receiving cyclosporine therapy. Patients taking warfarin or medication for thyroid disease should talk to ther healthcare provider before taking Alli.
Fatal Errors Tied to Label Similarities
The FDA and Baxter Healthcare have warned healthcare professionals about the potential for life-threatening substitution errors because of similarities in label coloring between 1 mL vials of 10,000 units/mL heparin sodium injection and the 10 units/mL preservative-free heparin lock flush solution.
The FDA's alert explained that inadvertent administration of the higher-concentration heparin injection rather than the low-dose flush solution has led to three deaths in infants. Both products use shades of blue as the prominent background color on their labels.
Healthcare professionals should stop relying on color to identify a product and to carefully review the drug name and dose on the label to ensure the correct product has been selected.
Package modifications that differentiate the products are being considered.
Fractures Associated with Rosiglitazone
The FDA found that female patients with recently diagnosed type 2 diabetes taking rosiglitazone (Avandia) for 4 to 6 years experienced more fractures of the upper arm, hand, or foot than female patients taking either metformin or glyburide.
The study compared glycemic control among over 4,000 patients taking rosiglitazone versus metformin and glyburide monotherapies.
The FDA recommends that healthcare professionals consider the risk of fracture when initiating or treating female diabetes patients with rosiglitazone.