Contraceptive approved

Long-acting, under-skin medication OK'd by FDA

July 19, 2006|By JONATHAN D. ROCKOFF | JONATHAN D. ROCKOFF,SUN REPORTER

WASHINGTON -- Adding to women's options for birth control, federal drug regulators announced approval yesterday of a long-acting contraceptive implanted in the upper arm.

The new drug, Implanon, is a matchstick-sized rod that steadily releases a small amount of the hormone progestin, preventing pregnancy. Tests in women found it 99 percent effective.

Doctors place Implanon just under the skin with a local anesthetic and can remove it at any time. Once it is removed, a woman could regain the fertility necessary to become pregnant within as little as a month, a federal regulator said.

The new drug will be the first implanted in the arm to be marketed in the United States since sales of Norplant were halted in 2000 amid concerns about its effectiveness and such serious side effects as excessive bleeding and headaches.

Other problems with Norplant arose because insertions and removals were performed by untrained doctors.

Dr. Scott Monroe, who heads the Food and Drug Administration's reproductive drugs office, expressed confidence that Implanon won't encounter the troubles that beset Norplant.

"Some of the issues related to Norplant, which were related to insertion and removal, will be much less of a concern with Implanon because it will involve a single rod," he said. Norplant required the insertion of six rods.

Implanon could cause irregular, unpredictable or no menstrual bleeding, and it is associated with an increased risk for blood clots. Women who use it are urged not to smoke because, like other hormonal contraceptives, it increases the risk of heart-related side effects.

The drug's manufacturer, Organon USA, the Roseland, N.J.,-based arm of a Dutch pharmaceutical company, hopes to avoid problems that beset Norplant by launching it slowly and selling it only to physicians who receive training in its insertion and removal.

The company will train doctors, starting later this year. Planned Parenthood issued a statement saying clinicians at 85 affiliates across the country will receive training starting in October and staff at its remaining centers will be trained this winter.

Implanon has been sold safely and effectively outside the United States since 1998 to more than 2.5 million women in 30 countries worldwide, Monroe said.

Dr. Lee P. Shulman, chairman of the Association of Reproductive Health Professionals, said the new implant might be especially appealing to women who seek a long-term birth control method but can't take existing products using the hormone estrogen.

"Probably a week doesn't go by that I don't have a patient who would be a good candidate," said Shulman, a professor of obstetrics and gynecology at Northwestern University who is a consultant for Organon and other pharmaceutical companies.

Many American women seeking birth control don't want long-acting devices, such as ParaGard, a plastic device inserted into the uterus that can prevent pregnancies for as long as 10 years if not removed, according to one women's health advocate.

jonathan.rockoff@baltsun.com

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