New Pill: Stops Menstruation and Prevents Pregnancy

The FDA has approved Lybrel, a birth control pill that halts menstrual periods and prevents pregnancy for as long as a woman uses it.

This pill, which will soon be marketed in packs of 24, is taken every day, without the standard four- to seven-day break that causes women using the common oral contraceptives to continue having menstrual periods.

The major problem with the new pill is unscheduled bleeding or spotting, which was the main reason that about half of the more than 2,400 women stopped taking the pills during two, year-long clinical trials.

A large percentage of the women who completed the trials also reported having spotting or bleeding on an average of four to five days during each 28-day cycle. The researchers say that such bleeding events will probably become less frequent after a woman takes the pill for a longer period of time.

Lybrel — a combination of low doses of two hormones, a progestational agent (levonorgestrel) and ethinyl estradiol, both of which are found in many but not all current oral contraceptives — had no other significant adverse effects during the trials.

Oral contraceptives, however, are associated with an increased risk of blood clots and dangerous emboli that can cause a stroke. These adverse effects of oral contraceptives are more common in cigarette smokers and older women.

Therefore, the FDA has asked the drug manufacturer, Wyeth, to carry out a post-marketing study to determine the risk of blood clots and any other possible long-term risks of taking Lybrel. In addition, unexpected pregnancies have occurred in some women taking low-dose birth control pills.

And there's a yet another consideration with Lybrel: since women taking it will not have the warning of a missed period to suggest pregnancy, they will need to get a pregnancy test whenever they suspect they are pregnant.

Given the inconvenience of unscheduled bleeding, as well as uncertainties about long-term safety, should women take Lybrel? Those who are moderately troubled by their menstrual periods might give the drug a try, to determine if they might be among the minority of women who do not experience break-through bleeding.

But the most suitable candidates for this pill are women who have severe cramps and other bothersome symptoms with their menstrual periods. Relief of these symptoms may well trump any problems caused by unscheduled bleeding.

A third option is to await the outcome of long-term safety studies carried out by Wyeth after the pills have been taken by large numbers of women.

However, considering the poor record of drug companies in doing these post-marketing studies, and the failure of the FDA to sanction companies for not completing them, women should not hold their breaths in hopes that they will soon be assured of the long-term safety of Lybrel.