It was reported yesterday that the European version of the morning after pill (Plan B) called Norlevo is not always effective for women over 165 pounds and doesn’t work at all for women who weigh 176 pounds and more.
HRA Pharma, the company who manufactures Norlevo, will change its packing information to reflect this new information about the weight limits. MotherJones.com, a nonprofit news organization that specializes in investigative, political, and social justice reporting, was the first to report this yesterday.
According to FOX5NY News, the FDA is now testing the American version Plan B One-Step to see if it has the same ineffectiveness and if there is a need to change the packaging. There are generic morning after pills with the same dosage and chemical makeup, such as Next Choice One Dose and My Way, and it has not been reported if those are being tested as well.
FDA spokesperson Erica Jefferson told CNN.com:
“The agency will then determine what, if any, labeling changes to emergency contraceptives are warranted.”
With the average American woman a size 14 and weighing 166 pounds, this development is extremely serious as that means the morning after pill will not work for a huge percent of American women. The Plan B One-Step pill is the only morning after pill available over the counter, without a prescription, to women of all ages in the United States.
Mother Jones.com reports:
HRA Pharma began investigating the need to change Norlevo’s label after Anna Glasier, a professor of obstetrics and gynecology at the University of Edinburgh, published research in 2011 showing emergency contraceptive pills that use levonorgestrel are prone to fail in women with a higher body mass index.
In an email, Karina Gajek, a spokeswoman for HRA Pharma, says that by December 2012, the company had reviewed clinical data on its own and requested permission from a European Union governing body to update its product information.
The new packaging on Norlevo boxes will be seen in Europe during the first half of 2014. The most alarming thing? Norlevo is sold parts of China, parts of the Middle East, many Francophone African countries, Australia, Taiwan, and South Korea as well as being recently approved for sale in India. It took a full year for this label to be created for the European market so we can only imagine how long it will take to reach other parts of the world.
An HRA spokesperson told MotherJones.com that the label changes in other countries will happen but it will be “procedure and country-dependent” with the company not on any set timetable.
As always, if you plan to take this pill or are in need of an emergency contraceptive and weigh over 165 pounds, talk to your doctor immediately about alternative emergency contraceptive options and ask questions. Be in the know.
As this story develops, we will report further about it.