New Products

November 1, 2007

The latest in medical products for obstetrics and gynecology.

Flu vaccine approved

Afluria is a purified, inactivated, trivalent influenza vaccine propagated in embryonated chicken eggs. Each dose delivers the required dose of influenza virus hemagglutinin antigens from strains recommended by the relevant FDA's advisory committee for the 2007-2008 season. CSL's licensing application submission was based on previous inter national flu vaccine studies sponsored by CSL Limited and a Phase III double-blind, placebo-controlled randomized clinical trial conducted by the National Institutes of Health involving 1,357 volunteers at nine clinical sites nationwide.

FDA approves Evista for reducing risk of invasive breast Ca

The osteoporosis drug raloxifene hydrocholoride now has two new indications. Specifically, the FDA approved the selective estrogen receptor modulator (SERM) in mid-September for lessening the risk of invasive breast cancer for use in postmeno pausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. Tamoxifen and Evista are now the only drugs approved to reduce breast cancer risk. (Evista was approved to prevent and treat osteoporosis in postmenopausal women in 1997 and 1999, respectively.)

Three clinical trials conducted over the last decade among 15,234 postmenopausal women, which compared the SERM with placebo, showed that Evista decreases the risk of invasive breast cancer by 44% to 71%, the federal agency said. Another trial of 19,747 postmenopausal women at high risk for developing breast cancer, which compared Evista with tamoxifen, found that women taking the two treatments had a similar risk of developing invasive breast cancer. Because the drug can cause serious side effects like blood clots and death due to stroke, an FDA spokesman cautioned clinicians to carefully evaluate the benefits and risks of taking Evista for each individual woman. For more information, visit http://www.fda.org/ and http://www.evista.com/.

Pocket guide on drug risks during pregnancy and breastfeeding

This time around, the guide to risk from drugs and substances that might be taken by reproductive-aged women is structured according to indication group rather than alphabetically for easier drug comparison, and includes a removable quick reference card on the safety of most frequently used drugs. The book contains new information on herbs, vitamins, and supplement use during pregnancy and expanded chapters on antiepileptics, psychopharma cologic agents, disease modifying drugs, and cancer therapy. For further details, visit the publisher's Web site at http:// http://www.elsevier.com/wps/find/bookdescription.authors/711717/description#description/.

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