Company offers to fund alternative contraception for
thousands of women
Norplant
consists of six matchstick-size capsules implanted in the upper arm
that are supposed to prevent pregnancy for five
years.
MSNBC
NEWS SERVICES
Sept. 13
— The maker of the Norplant contraceptive will
pay for thousands of women with the birth-control implant to buy
backup contraception because it cannot guarantee the effectiveness
of certain Norplant
batches.
Wyeth-Ayerst
said it will pay $100 toward the cost of backup birth control and offered
to reimburse women $700 if they choose to have the implant removed.
IN A STRONGLY worded warning Wednesday, Wyeth-Ayerst Laboratories, a
unit of American Home Products Corp., urged women who have received
Norplant since Oct. 20 to use a nonhormone form of birth control such as
condoms or a diaphragm as a backup. The company also asked doctors to
check their records and notify these Norplant recipients.
The caution was stronger than the company’s advice last
month, when it asked physicians to stop implanting the suspect kits and
consider recommending backup birth control for women who were especially
worried about getting pregnant. Wyeth-Ayerst
spokeswoman Audrey Ashby said the company issued the new advice because
officials had thought they would have completed tests on the suspect
Norplant batches by now. Full test results are now expected by the end of
October.
“We want information to
be provided to health-care providers and also to patients that they should
use a backup barrier or other nonhormonal birth control in the meantime,”
Ashby said. “The contraceptive effectiveness from Norplant from these
specific lots cannot be assured at this time.”
Wyeth-Ayerst did not recall the questionable Norplant, stressing
that tests so far have not proved that the batches contain hormone levels
so low as to truly risk pregnancy. The company said it wanted to err on
the side of caution.
The company said it will pay $100 toward the cost of backup birth
control and offered to reimburse women $700 if they choose to have the
implant removed. “The aim here is to do the
right thing for people, recognizing there are still unanswered questions
but saying we don’t want people to be unduly anxious and we don’t want
them to be out of pocket,” said Dr. Philip de Vane, Wyeth-Ayerst’s
assistant medical director. Laboratory
testing suggests about 22,000 Norplant kits shipped to doctors on Oct. 20,
with the expiration date 2004, may release less contraceptive hormone than
they should. Most of those kits were already implanted.
Although the hormone levels are within the Food and Drug
Administration’s requirements, they are on the low end and lower than any
other batches of Norplant.
The FDA said it has no
reports that pregnancy rates have increased among Norplant users. The
agency said the company’s decision to warn women about backup birth
control was appropriate. The FDA advised
women who had Norplant inserted since Oct. 20 to call their doctors about
backup birth control. Norplant recipients should not use hormonal
contraceptives — such as birth control pills or injected contraceptives —
but should consider condoms, spermicide, a diaphragm or an IUD, or
intrauterine device, the FDA said.
Advertisement
Quick
Gifts Swimwear
Books
Music &
Video Computing Electronics Toys & Games
More . .
.
About 1 million American women and 5 million women worldwide have
used Norplant, which consists of six hormone-filled capsules that are
implanted in a woman’s upper arm and slowly release enough hormone to
provide contraception for five years. Women
who began using Norplant before Oct. 20 are not affected by Wednesday’s
warning because those implants contain the proper hormone
amount. Women and doctors can call
Wyeth-Ayerst at 1-800-364-9809 for information or financial
assistance.
The Associated Press and Reuters contributed to this
report.