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 women weighing more than 75 kilograms and that it
didn't work for women more than 80 kilograms. HRA Pharma changed its labels to
warn patients after consulting with European regulators.
In a statement, the EMA said it would evaluate new data suggesting
that a high body weight could compromise the effectiveness of the morning-after
"This is an efficacy issue," said Monika Benstetter, an agency
spokeswoman. "We need to find out what the association is with (body mass
index) and if there is a cut-off threshold for when the medicine becomes less
Assessment of all products
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
The US Food and Drug Administration said it was also studying
The morning-after pill can be taken up to 72 hours after unprotected
sex. It contains a higher dose of the hormone in regular
birth control pills 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.
pill ineffective for heavier women
more about contraception
– now and then