Barr set to acquire IUD manufacturer
Intrauterine contraception may see a wider audience in the United States with a major pharmaceutical company’s acquisition of the manufacturer of the ParaGard TCu 380A intrauterine device (IUD). Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals in Woodcliff Lake, NJ, has announced its intention to acquire FEI Women’s Health of North Tonawanda, NY. At press time, the company said it expected to close the transaction before Dec. 31.
The change comes almost two years after FEI, the longtime manufacturer of the device, secured the U.S. marketing rights for the TCu 380A from the Population Council in New York City. The TCu 380A was codeveloped by the Population Council and FEI in the 1970, and it recently was marketed by Ortho McNeil Pharmaceuticals of Raritan, NJ.
The TCu 380A, approved for contraceptive use up to 10 years by the Food and Drug Administration, is the most widely available IUD in the world. In a comparative study of five countries (Italy, Spain, Poland, Germany, and Denmark), the IUD accounted for 9%-24% of all contraceptive use.1 The proposed change could expand IUD use in the United States, reports Allan Rosenfield, MD, dean of the Mailman School of Public Health at the New York City-based Columbia University.
Barr Pharmaceuticals, which plans to market the device through its Duramed subsidiary, says it will bolster its sales force in adding the new contraceptive option to its line of products. "IUDs represent an underutilized contraceptive option for women in the United States, and we believe that we are well positioned to grow this category through consumer and professional education and marketing," says Bruce Downey, Barr’s chairman and chief executive officer.
U.S. women have two options in intrauterine contraception: the Mirena levonorgestrel intrauterine system marketed by Berlex of Montville, NJ, and the ParaGard TCu 380A IUD. Other IUDs are in use in other global markets, with research ongoing in intrauterine contraception.
Myths still persist
Myths still exist about intrauterine contraception, and misinformation about the method is common, according to information presented at the Association of Reproductive Health Professionals’ 2005 meeting.2
IUDs are not abortifacients; they do not cause ectopic pregnancies or pelvic infection, according to the presentation given by Kirtly Parker Jones, MD, professor in the department of obstetrics and gynecology at the University of Utah Health Sciences Center in Salt Lake City. They also do not decrease the likelihood of future pregnancies. A 2001 case control study helps to refute the myths that IUDs cause pelvic inflammatory infection, increase ectopic pregnancy and infertility, and are inappropriate for young or never-pregnant women.3
Intrauterine devices may not need to be removed for treatment of pelvic inflammatory disease4; they also do not have to be removed if actinomyces-like organisms are noted on a Pap smear.2
The TCu 380A is an effective option for women who choose not to use hormonal contraceptives or who are considering tubal ligation. While the device is approved for 10 years of use in the United States, recent research indicates it may provide effectiveness for a longer period of time.5
In a study of women who had been using the device for more than 10 years and who were 35 years of age or older on completion of the 10th year of IUD use, researchers found that found no evidence that the device loses its effectiveness after 10 years of use. "The concept that women who have insertion of a TCu 380A IUD at the age of 25 years or older could use this IUD as a reversible but permanent method of contraception up to the menopause continues to be supported by the accumulation of evidence, although definitive evidence remains to be obtained," the researchers conclude.
References
- Spinelli A, Talamanca IF, Lauria L. Patterns of contraceptive use in 5 European countries. Am J Public Health2000; 90:1,403-1,408.
- Jones KP. Intrauterine contraception. Presented at Reproductive Health 2005. Tampa/St. Petersburg, FL; September 2005.
- Hubacher D, Lara-Ricalde R, Taylor DJ, et al. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. N Engl J Med 2001; 345:561-567.
- Grimes DA. Intrauterine device and upper-genital-tract infection. Lancet 2000; 356:1,013-1,019.
- Bahamondes L, Faundes A, Sobreira-Lima B, et al. TCu 380A IUD: A reversible permanent contraceptive method in women over 35 years of age. Contraception 2005; 72:337-341.
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