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As the contraceptive injectable Lunelle (Pharma-cia Corp., Peapack, NJ) is being added to the list of options at many family planning sites, the contraceptive implant Norplant (Wyeth-Ayerst Laboratories, Philadelphia) is being subtracted due to unavailability of new product.
Almost 60% of respondents to the Contraceptive Technology Update 2001 Contraception Survey say their facility is offering Lunelle injections or is planning to do so before the close of the year. The drug, which contains 25 mg of medroxyprogesterone acetate and 5 mg of estradiol cypionate in each monthly dose, offers safe, effective, and easily reversible contraception. (For more information on Lunelle, see CTU’s special news bulletin inserted in the November 2000 issue, the article in the December 2000 issue, p. 144, and the special Contraceptive Technology Reports inserted in the March 2001 issue.)
"We are seeing more teens who want injectables going with Lunelle," Jeffrey Maurus, MD, medical director of the Rock Island (IL) County Health Department. "Regular periods and less chance of weight gain are important noncontraceptive benefits."
Arlington (VA) County Department of Human Services does not offer Lunelle, according to Linda Hedlund, MD, medical supervisor. Cost and scheduling of monthly injections are barriers, she notes.
"We are thinking about making it available to women who are not good pill takers and who have had problems with Depo [Provera, depot medroxyprogesterone acetate, Pharma-cia Corp.]," Hedlund says. "If the state would pay for Lunelle like they have Depo, we would be more inclined to use it."
Lunelle is available at Kaiser Permanente Northern California in Oakland, but it is in limited use while the staff examine how to handle the additional workload of monthly injections, says Ruth Shaber, MD, women’s health leader. Clinicians will offer the inject-able to those women who are unable to tolerate pills, unable to follow pill regimens, or experience too many side effects with Depo-Provera, Shaber states.
Norplant on hold
Wyeth-Ayerst Laboratories has shipped no new Norplant implants since it issued an advisory in August 2000 that alerted providers that routine shelf-life stability laboratory tests indicated product from certain specified lots might not release enough levonorgestrel to deliver effective, ongoing contraception. (For complete information on the suspect lots, see the October 2000 issue, p. 117, and November 2000 issue, p. 129, of CTU.) Some 22,000 kits were contained in the suspect lots, according to company estimates.
Wyeth-Ayerst continues to work with the Food and Drug Administration (FDA) to evaluate information about the suspect lots, says company spokeswoman Audrey Ashby. The company is unable to provide an exact date or timeline on when the matter will be resolved, she states.
While the evaluation continues, providers have seen a continued drop-off in Norplant use. According to the 2001 CTU survey, about 56% of respondents said they inserted no new implants in the past year. About 30% said they had performed up to 10 insertions, with about 13% reporting more than 10 procedures. As for removals, about 42% reported no such procedures, with about 55% performing one to 10 procedures, and the remaining 3% performing more than 10 removals. (See charts on Norplant insertions and removals, below.) About 74% of respondents in the 2000 survey said they had inserted no implants, with about 71% saying they had performed no removals.
"We recently inserted the last Norplant we had in stock," states Maurus. "Use has been down, and I do not expect to see Norplant back on the market."
Norplant has not been available for the past year at Arlington County Department of Human Services, but prior to that time, clinicians had seen declining requests for the method, notes Hedlund.
Examine seven-year data
Anita Nelson, MD, professor in the obstetrics and gynecology department at the University of California in Los Angeles (UCLA) and medical director of the women’s health care clinic and nurse practitioner training program at Harbor-UCLA Medical Center in Torrance, points to recent published data that indicate Norplant offers up to seven years of effective use, which is two years beyond the current labeling approved by the FDA.1
Among women ages 18-33, the seven-year Norplant pregnancy rates are comparable to the median pregnancy rates of tubal sterilization methods for women of the same age and duration of use. For women ages 34 and older, the seven-year effectiveness of Norplant equals or surpasses that of tubal sterilization, researchers found. (For more information on the study, see CTU, August 2000, p. 91.)
Clinicians should keep these data in mind when evaluating current Norplant users, says Nelson.
1. Sivin I, Mishell DR Jr., Diaz S, et al. Prolonged effectiveness of Norplant capsule implants: A seven-year study. Contraception 2000; 61:187-194.