About Careers Internship MedBlog Contact us
Medindia LOGIN REGISTER
Advertisement

French Morning-After Pill Approved by US Panel

by Kathy Jones on June 18, 2010 at 6:38 PM
 French Morning-After Pill Approved by US Panel

The sale of a controversial French birth control pill, which can prevent pregnancy for up to five days after unprotected sex, has been approved by a US panel.

The final decision by the Food and Drug Administration (FDA) is not expected for several months, but the so-called morning-after pill "Ella" got the nod of approval by 11 medical experts on an FDA advisory panel who deemed it safe.

Advertisement

The move is likely to stir controversy from the anti-abortion movement, because of the way it works. The manufacturers, France's HRA Pharma laboratory, say it delays ovulation, while opponents maintain it works by stopping a fertilized egg from implanting in the walls of a woman's uterus.

"We are delighted the committee was able to confirm our product's effectiveness," top US executive Erin Gainer from HRA Pharma told AFP.

"We're optimistic" Ella will get the FDA's green light for sale in the United States, she added. The panel's advice is not legally binding on the FDA, but it is usually followed.
Advertisement

HRA said it hopes to market Ella in the United States by the end of the year through its US partner Watson Pharmaceuticals. As in Europe, it would be sold by prescription on the US market.

In the United States, it would be in competition with Plan B, already available over the counter here, and its generic version, Next Choice.

But the longer contraceptive period offered by Ella -- five days as opposed to three days for Plan B -- could raise controversy with anti-abortion groups who consider its effects more akin to abortion than birth control.

As a precaution, two police officers were posted at the hotel outside Washington where the public, medical debate over the new pill was held. There was no trouble.

Ella's chemical composition is also similar to the RU-486 abortion pill that prevents pregnancy for up to nine weeks after intercourse. Introduced 10 years ago in the United States, RU-486 raised the hackles of the anti-abortion crowd.

"The big elephant in the room is whether or not this medication is inducing some sort of abortion," said a member of the FDA panel.

"This drug is not to be used if already pregnant," said Gainer from the manufacturers.

Ella's yearly sales in Europe reach 36.5 million euros and its US potential is "several hundred million dollars," according to Gainer.

The FDA panel asked many questions about the drug's apparently reduced effectiveness in overweight women, and its side effects.

"The most common adverse reactions were nausea, headache, dysmenorrhea, abdominal pain, fatigue, and dizziness," the FDA advisory committee reported on the results of Ella's clinical trials with 4,700 women.

Several women's aid groups testified before the committee and largely backed the marketing of Ella in the United States.

"The US has one of the highest teen pregnancy rates in the developed world. We have more than six times the pregnancy rate of the Netherlands, almost four times that of Germany and almost three times that of France," Advocates for Youth manager Sarak Audelo told the panel in support of the French pill.

Concerned Women for America president Wendy Wright however compared Ella to the abortion pill RU-486 which she said has caused seven deaths since it was introduced in this country.

"Ulipristal or Ella is similar to mifepristone (RU486) a drug that causes an abortion," she said.

"RU-486 was approved without adequate ttrials and even with restricted distribution has resulted in thousands of complications including deaths."

Source: AFP
Font : A-A+

Advertisement

Advertisement
Advertisement

Recommended Readings

Latest Drug News

Amoxicillin-Calvulanate Vs Amoxicillin Preference in Child Sinusitis Treatment
Amoxicillin-clavulanate use in acute sinusitis patients is associated with a higher incidence of adverse events.
ADHD Medication Errors Surge by Nearly 300%
Professionals advocate for enhanced education of patients and caregivers, and creation of more effective child-resistant systems for monitoring ADHD medication.
Unknown Medication Side Effects Reported by 52% of Indian Families
In June, WHO raised concerns about 7 Indian cough syrups after complaints from several countries about contamination and health issues.
Painkillers With Hormonal Contraception Linked to Blood Clot Risk
Women using hormonal contraception, along with their healthcare providers, should explore alternative pain relief options instead of NSAIDs.
Finger Sweat Test Enables Antipsychotic Drug Detection
The recently created assay identifies antipsychotic drugs present in sweat.
View All
This site uses cookies to deliver our services.By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use  Ok, Got it. Close
MediBotMediBot
Greetings! How can I assist you?MediBot
×

French Morning-After Pill Approved by US Panel Personalised Printable Document (PDF)

Please complete this form and we'll send you a personalised information that is requested

You may use this for your own reference or forward it to your friends.

Please use the information prudently. If you are not a medical doctor please remember to consult your healthcare provider as this information is not a substitute for professional advice.

Name *

Email Address *

Country *

Areas of Interests