Morning-after pill may not work in heavier women

The European Medicines Agency says it has started a review of emergency contraceptives to see if they work less well in heavier women.

In November, French drug maker HRA Pharma announced its morning-after pill Norlevo was less effective in weighing more than 75 kilograms (165 pounds) and that it didn't work for women more than 80 kilograms (176 pounds). HRA Pharma changed its labels to warn patients after consulting with European regulators.

In a statement on Friday, the EMA said it would evaluate new data suggesting that a high body weight could compromise the effectiveness of the morning-after pill.

"This is an efficacy issue," said Monika Benstetter, an agency spokeswoman. "We need to find out what the association is with () and if there is a cut-off threshold for when the medicine becomes less effective."

HRA Pharma's Norlevo contains levonorgestrel, the same active ingredient in other medicines including ellaOne, Levonnelle and Levodonna. One of the studies that prompted the label change on Norlevo found the risk of emergency contraception failing was higher in women with a body mass index higher than 25, considered to be overweight.

EMA's Benstetter said the agency needed to perform an assessment of all products in the same category as Norlevo to ensure labels across the European Union are consistent. She said there was no timeline on when the review would be completed.

In November, the U.S. Food and Drug Administration said it was also studying the issue.

The morning-after pill can be taken up to 72 hours after unprotected sex. It contains a higher dose of the hormone in regular and works by preventing ovulation or fertilization of an egg. It has no effect if a woman is already pregnant.

Some doctors have previously advised that heavy women consider alternatives like a copper IUD, a birth control device that can be fitted on the uterus.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

New morning-after pill works for up to 5 days

Jan 29, 2010

(AP) -- A new type of morning-after pill is more effective than the most widely used drug at preventing pregnancies in women who had unprotected sex and also works longer, for up to five days, a new study says.

FDA panel to consider new 'morning-after pill'

Jun 08, 2010

A Food and Drug Administration advisory committee will meet June 17 to consider whether the agency should approve a new emergency contraceptive that studies show is more effective than Plan B, the only "morning-after pill" ...

Recommended for you

WHO: Millions of Ebola vaccine doses ready in 2015

Oct 24, 2014

The World Health Organization says millions of doses of two experimental Ebola vaccines could be ready for use in 2015 and five more experimental vaccines will start being tested in March.

Added benefit of vedolizumab is not proven

Oct 23, 2014

Vedolizumab (trade name Entyvio) has been approved since May 2014 for patients with moderately to severely active Crohn disease or ulcerative colitis. In an early benefit assessment pursuant to the Act on the Reform of the ...

Seaweed menace may yield new medicines

Oct 22, 2014

An invasive seaweed clogging up British coasts could be a blessing in disguise. University of Greenwich scientists have won a cash award to turn it into valuable compounds which can lead to new, life-saving drugs.

User comments