Morning-after pill may not work in heavier women

January 24, 2014

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.

Explore further: French drugmaker warns on morning-after pill (Update)

Related Stories

French drugmaker warns on morning-after pill (Update)

November 26, 2013
A French contraceptive maker said Tuesday its morning-after pill doesn't work when taken by women who weigh more than 80 kilograms (176 pounds) and plans to change its labels to warn patients.

EU drug agency rejects French request on birth pills

October 11, 2013
The European Medicines Agency (EMA) on Friday rejected a French request to tighten prescription guidelines on types of birth-control pills linked with a relatively higher risk of blood clots.

EU drug agency to review safety of new-generation Pill (Update)

January 28, 2013
The European Medicines Agency (EMA) on Monday said it would review safety data for third- and fourth-generation birth control pills, responding to French concern that these contraceptives may cause dangerous blood clots.

Recommended for you

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.