New Products: Adiana permanent contraception system, zoledronic acid for prevention of postmenopausal osteoporosis

FDA approves new permanent contraception alternative to ligation

Adiana's approach uses a catheter to deliver a small amount of radiofrequency (RF) energy to the intramural portion of the fallopian tube to create a superficial lesion. Then a biocompatible implant is placed at the site of the lesion, stimulating a biologic response that causes tubal occlusion. During the 3 months following the procedure, the patient continues to use temporary birth control while new tissue grows in and around the Adiana inserts, eventually blocking the fallopian tubes. At 3 months, a hysterosalpingogram must be performed to confirm the tubes are completely blocked; then the patient may begin relying on Adiana alone.

FDA okays prevention indication for Reclast

The FDA has approved Reclast (zoledronic acid 5 mg) injection as the first and only therapy to prevent postmenopausal osteoporosis for 2 years with a single dose. The product from Novartis Pharmaceuticals Corporation (East Hanover, NJ) is already approved as a once-yearly infusion to treat this condition, to increase bone mass in men with osteoporosis, and to treat and prevent osteoporosis caused by glucocorticoids. It's also approved to treat Paget's disease of bone.

The federal agency based its decision on a study that involved more than 500 postmenopausal women with osteopenia, which showed that a single infusion of Reclast significantly increased bone mineral density at 2 years compared to placebo. The randomized, multicenter, doubleblind, placebo-controlled study of 581 postmenopausal women older than age 45 had as its primary endpoint the change in BMD at 2 years compared to baseline. It included women in early menopause and late menopause divided into three groups: Patients received either Reclast at the beginning of the study and again at 1 year, at the beginning of the study and placebo at 1 year, or placebo at both times.

Treatment with a single initial dose of Reclast raised lumbar spine BMD by 6.3% in the younger group and by 5.4% in the late menopause group at 2 years (both P<.0001. Among contraindications are patients already taking Zometa injections (zoledronic acid, which contains the same active ingredient as Reclast); also be sure your patients inform you of dental problems due to rare jaw problems.

For more information, visit http://www.reclast.com/ or call 866-RECLAST (866-732-5278).