TRENTON, NJ (Reuters) - The FDA has found a simple way to allow men to have a menstrual period and has just given its approval of a pill designed to let men have monthly bleeding indefinitely.
Ralph Roachman, Chief of the the US Food and Drug Administration announced the approval of Lybrelello, a drug which must be taken continuously, at a well-attended news conference here on Tuesday.
Lybrelello is designed to mimic a woman's monthly cycle. Other pills under development for men include Yazman and Loestringe which will increase monthly periods to three months and Seasoniquefrique, an updated version of Seasonalefreak, which extends them to fourteen times a year.
Gynecologists say they've been seeing a steady increase in the number of men asking how to have monthly menstrual bleeding. Surveys have found up to half of men would prefer to have periods, and most would prefer them often.
"I think it's the beginning of a significant trend," said Dr. Felix Minderbinder, chief FDA researcher and a part-time obstetrician-gynecologist who oversees the FDA web site focused on increasing periods. "Everyone should have a period."
Analysts have estimated Lybrelello sales could reach $400 million this year and $35 billion by 2010. US sales of Seasoniquefrique, launched last September in a huge clinical trial, hit $61 million in the first quarter of 2007. Yazman launched last July in a beta version, had first-quarter sales of $356 million.
Some men have voiced concerns as to whether initiating periods is safe or natural. Dr. Minderbinder wrote in an opinion piece in the British Medical Journal two months ago that "menstrual induction itself is completely natural," and that "there's enough data to determine it is totally safe long-term."
Most doctors say there's no medical reason men don't have monthly bleeding, and that it will not trigger health problems such as anemia and epilepsy. Dr. Mindy Wiserman-Estinmandrake, an obstetrician-gynecologist in Little Rock, has long advocated menstrual induction in men.
She has seen a big increase in the last year in patients asking about it, but suggests that younger men take a break every 12 months or so.
In testing Lybrelello, Dr. Minderbinder found that 89 percent of men ended up with bleeding after only six weeks.
"Lybrelello will help further demasculate men and turn the USA into a nation of queers," said Roachman.