FDA Approves Country's First Once-a-Month Birth Control Option
Oct. 6, 2000 (Washington) -- The FDA has approved a contraceptive shot named Lunelle, a once-a-month birth control option that is the first of its kind in the United States.
Made by Pharmacia Corp. of Peapack, N.J., Lunelle is somewhat like the birth control pill and also is comparable to the contraceptive Depo-Provera, which is given as an injection and lasts three months.
Lunelle is more than 99% effective when administered as scheduled, offering women a reliable and convenient birth control option, says Anita Nelson, MD, a noted gynecologist at the University of California Harbor Medical Center and one of the U.S. clinical trial investigators.
In clinical trials, Lunelle was compared with Ortho-Novum 7/7/7, a leading oral contraceptive. There were no unintended pregnancies among the 782 women taking Lunelle and two unintended pregnancies among the 321 women using the pill.
Daniel Wattf of Pharmacia Corp. tells WebMD that research has shown women have a tendency to miss a pill here and there. Lunelle was designed for those women who don't like the pill or who can't seem to remember to take it on a daily basis, he says.
But the company cautions that women must get the shot every 28 to 33 days or else they will need to get a pregnancy test prior to the next injection. Like the pill, Lunelle allows for a quick return to fertility after it is stopped, Wattf explains.
As with other contraceptives, Lunelle also is considered inappropriate for pregnant women and those women who tend to form blood clots; have disease of the heart, liver, or the brain's blood vessels; have diabetes or hypertension; or have certain types of cancer. Heavy smokers over the age of 35 and some women with abnormal bleeding of the uterus also are discouraged from using Lunelle.
In terms of other precautions, the FDA adds that Lunelle does not protect against HIV or other sexually transmitted diseases.
The shot, which must be administered by a health care professional, should be available by the end of the year, Wattf tells WebMD. He adds that its cost will be comparable to the pill, or about $35 per shot.