Long-lasting, reversible, implantable contraceptive approved
In clinical trials of 942 healthy reproductive-aged women, the device was found to be safe and 99% effective-or just as effective as the Pill. Since 1998, Implanon has been used worldwide in more than 30 countries. Physicians can sign up for the training or learn more about the product by logging onto http// http://www.IMPLANON-USA.com/ or calling 1-877-IMPLANON (1-877-467-5266).
The FDA has approved a combination of Hycamtin (topotecan hydrochloride) and cisplatin as the first drug treatment for women with late-stage cervical cancer to be given when surgery or radiation therapy is unlikely to be effective. The approval includes a new indication for GlaxoSmithKline's (Research Triangle Park, N.C.) Hycamtin, which was approved in 1996 for treating ovarian cancer and in 1998 for small cell lung cancer.
The combination of Hycamtin and cisplatin is specifically indicated for women with stage IVB (incurable), recurrent, or persistent cervical cancer that spreads to other organs and is not likely to respond to surgical or radiation treatment.
In clinical trials, 293 patients were randomized to Hycamtin plus cisplatin or to cisplatin alone. Most subjects had received prior radiation therapy as the standard treatment, while some may have undergone prior surgery. The combination therapy significantly improved survival compared to cisplatin alone. Women on combined therapy survived (9.4 months), about 3 months longer than patients on cisplatin alone (6.5 months).
Hycamtin is linked with a significant risk of neutropenia (a drop in WBC count). Thrombocytopenia is another serious side effect, while nausea and vomiting are less serious ones. Neutropenia, anemia, and thrombocytopenia were significantly more likely in patients receiving the combo treatment (as were nausea and vomiting, mucositis, rash, and liver toxicity) compared to those receiving cisplatin alone. For more information, visit the FDA Web site at http:// http://www.fda.gov/.
Upgraded ultrasound system features 3D eXtended Imaging
Three tools are included in this package: Multi-Slice View (which turns 3D volume data into sequential image segments for instant analysis of in-depth data), Oblique View, and VolumeCT. For more information, visit the company's Web site at http:// http://www.MedisonUSA.com/.
New imaging option for women at high risk for breast Ca
During the Mammotome MR procedure, the surgeon inserts a needle equipped with a vacuum device into a ¼-inch incision. Under MRI guidance, the device vacuums, cuts, and partially or totally removes suspicious breast tissue for evaluation. No stitches are required for this outpatient procedure, which usually takes less than an hour. With this advance, the product can now be used with all three imaging modalities-stereotactic, ultrasound, and now MRI-to detect and diagnose breast abnormalities. The device's targeting sleeve is the only system that currently allows physicians to visualize the sampling area/aperture in MR.
The Mammotome MR can be purchased in its entirety or as an upgrade to an existing Mammotome Breast Biopsy System and is compatible with many magnet, breast coil, and computer-aided detection (CAD) options. For more information, visit http:// http://www.breastbiopsy.com/ or call 800-USE ENDO (800-873-3636).
Prenatal vitamin debuts
The maker of Citracal prenatal vitamins has added Citracal Prenatal + DHA to its product line. According to Mission Pharmacal Co. (San Antonio, Tex.), the Citracal prenatal pack offers a balanced daily dose of prescription-strength vitamins and minerals in a tablet and a 250-mg capsule of Martek DHA, a plant-derived essential omega-3 fatty acid.
The company points out that women reluctant to eat fish due to potentially high mercury levels might feel more comfortable taking the tablet as an alternative. DHA is found chiefly in tuna, salmon, and deep-water fish, and in some algae.
The plant-derived DHA portion is produced exclusively by Martek Biosciences Corporation (Columbia, Md.), which makes the only DHA accepted for use in infant formula by the FDA.