US Approval for Pill That Halts Periods

May 24, 08:00 AM

Current Headlines: By Lyndsay Moss Health Correspondent

THE first birth control pill designed to stop women having monthly periods has won approval for use in the United States.

When taken daily, Lybrel can halt menstrual periods indefinitely, as well as prevent pregnancy, according to the manufacturer, Wyeth.

It is the first oral contraceptive developed to put off periods altogether when taken without a break to be approved by the US Food and Drug Administration.

For many, it will be a welcome alternative to the "21 days on, seven days off" regime that has been standard since the Pill launched in the 1960s.

But a US official warned that the Pill was not for everyone and about half the women enrolled in studies of Lybrel dropped out before the end.

Dr Daniel Shames, the deputy director of the FDA's drugs office, said many did so because of the irregular bleeding and spotting that could replace scheduled periods.

"If you think you don't want to go down this road, this is not for you," Dr Shames said.

Wyeth plans to start Lybrel sales in the US in July, and it is expected to be licensed for use in the UK in the future.

The Pill contains a low dose of two hormones already used in birth control pills, ethinyl estradiol and levonorgestrel.

A study showed Lybrel was just as effective in preventing pregnancy as a traditional Pill called Alesse, which is also made by Wyeth. But it may be difficult for women to recognise if they have become pregnant, because Lybrel users will not have regular periods.

In one test, 59 per cent of the women who took Lybrel for a year had no bleeding or spotting during the last month of the study.

However, because of drop-outs, that translates into only about a third of all the women originally enrolled in the study, Dr Shames said.

Tim Street, the Family Planning Association director for Scotland, said the new Pill offered increased choice for women and said he expected it would be made available in the UK soon.

"For some women, this will be a really welcome option, for example if they have difficult periods with headaches and severe cramps," he said.

"It is not going to be for everyone, but it is something we would hope would be offered to those who might benefit, and so we welcome it."

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