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Entries in Morning After Pill (5)

Wednesday
May092012

IUDs Work Best for Emergency Contraceptive, Study Finds

Spike Mafford/Photodisc/Thinkstock(PRINCETON, N.J.) -- Intrauterine devices, or IUDs, have been shown to be the best and most reliable emergency contraceptive for women, according to a new study published in the journal Human Reproduction.

An IUD is a T-shaped plastic or copper device that is placed in a woman's uterus to prevent pregnancy.  They can be left in the womb between five and 10 years, depending on the brand, but they can also be used as a means of emergency contraceptive.  They should be inserted within five days of unprotected sex to properly protect, experts said.

The research showed that IUDs had a failure rate of less than one per 1,000, which was more effective than the morning-after pill, which had a failure rate of 1 to 2 percent.  The morning-after pill, or Plan B One-Step, is a pill that should be taken within 72 hours of unprotected sex to avoid pregnancy.

"Emergency insertion of a copper IUD is extremely effective," said James Trussell, professor of public and international affairs at Princeton University and lead author of the study.  "We would hope [the findings] would encourage clinicians to talk with women about emergency insertion of a copper IUD during regular visits for later use, should the need arise."

The study analyzed data from 42 studies conducted in six different countries (China, Egypt, Italy, The Netherlands, U.S.A. and the U.K.) between 1979 and 2011.  They found that women became pregnant at a rate of 0.09 percent if they used an IUD, as opposed to the 1 to 2 percent pregnancy rate on the morning-after pill.

The research also found that using an IUD for emergency contraception worked just as effectively in women with higher body mass index, while the morning-after pill became less effective at preventing pregnancy in women with higher BMI.

"IUDs are certainly a highly effective form of emergency contraception," said Dr. Ranit Mishori, an assistant professor in the department of family medicine at Georgetown University.  "The study appears to confirm it, [but] I think not many women are aware that it is an effective option."

While the device is indeed better at preventing pregnancy, experts say that it is not necessarily the best option for everyone.

"Here are the problems: the IUD has to be inserted and most of the time, ordered," said Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital in New York.  "They are way overpriced in this country.  You can't just walk in my office and get an $800 IUD.  We have to get it authorized and ordered."

On the other hand, any woman over the age of 17 can buy Plan B One-Step at a pharmacy without a prescription.  Females under the age of 17 must have a prescription to obtain the product.

Copyright 2012 ABC News Radio

Wednesday
Dec072011

Plan B: 'Morning After Pill' Blocked from Hitting Drug Store Shelves

Joe Raedle/Getty Images(WASHINGTON) -- U.S. Department of Health and Human Services Secretary Kathleen Sebelius has blocked the Plan B "morning after" birth control pill from hitting drug store shelves, countering recommendations from the U.S. Food and Drug Administration.

"Today's action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional," Sebelius wrote in a statement.

FDA Commission Dr. Margaret Hamburg said in a statement that she believes there is adequate and well-supported data that shows Plan B One-Step is safe and effective for nonprescription use for all females of childbearing years -- an opinion vetoed by Sebelius.

"Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application (SNDA) by Teva Women's Health, Inc.," Sebelius wrote.

The move would have landed the emergency contraceptive on drugstore shelves alongside condoms, spermicides and contraceptive sponges. Instead, women 17 and older can continue to buy the high-dose hormone pill over the counter, but girls younger than 17 still need a prescription.

Teva Pharmaceutical Industries Ltd., the maker of Plan B One-Step, requested the switch in February.

Plan B, or levonorgestrel, is a progestin-only emergency contraceptive that can prevent a fertilized egg from attaching to the wall of the uterus if taken within 72 hours of unprotected sex. The drug is not effective if the woman is already pregnant, and it reportedly does not pose harm to a fetus.

In 2008 the FDA ruled that women 18 and older could buy Plan B over the counter. A year later, the agency expanded the regulation to include those 17 and older.

Copyright 2011 ABC News Radio

Wednesday
Dec072011

FDA to Decide Whether to Lift Age Limit on 'Morning After Pill'

Joe Raedle/Getty ImagesUPDATE: U.S. Department of Health and Human Services Secretary Kathleen Sebelius has blocked the Plan B morning-after birth control pill from hitting drug store shelves, countering recommendations from the U.S. Food and Drug Administration.

(WASHINGTON) -- The Food and Drug Administration is set to weigh in on Wednesday whether the age limit on who can purchase an emergency contraceptive pill should be scrapped, making the drug available to everyone over the counter.

Plan B, also known as the "morning after pill," is currently available at the pharmacy counter without a prescription to women 17 and older.  Those who are younger can still get the pill, but they need to have it prescribed to them by their doctors.

Teva Pharmaceutical Industries Ltd., the makers of Plan B, issued the request in February to place its drug on store shelves.

"Label comprehension and safety data show that all women are able to safely and effectively take this product," Denise Bradley, senior director of corporate communications at Teva Pharmaceuticals, told ABC News at the time. "It is not typical for any women's health product to have age restrictions."

Plan B, or levonorgestrel, is a progestin-only emergency contraceptive that can prevent a fertilized egg from attaching to the wall of the uterus if taken within 72 hours of unprotected sex. The drug is not effective if the woman is already pregnant, and it reportedly does not pose harm to a fetus.

Copyright 2011 ABC News Radio

Tuesday
Jul192011

Health Law Could Require Coverage of ‘Full Range’ of Birth Control

Stockbyte/Thinkstock(WASHINGTON) -- A report released Tuesday and requested by the government recommends that the “full range” of birth control methods, including the “morning after pill” known as Plan B as well as oral contraceptives, should be offered to “all women with reproductive capacity” at no cost under the Affordable Care Act.

The Department of Health and Human Services requested the study to determine which preventative services are vital to women’s health and well-being and should be added to the co-pay free list.

HHS Secretary Kathleen Sebelius will make a decision by Aug. 1 on whether or not to include the recommendations.  They would go into effect one year after Sebelius makes her decision.

“This report is historic,” Sebelius said in a statement Tuesday. “Before today, guidelines regarding women’s health and preventive care did not exist.”

Planned Parenthood lauded the report in a statement.

“Millions of women, especially young women, struggle every day to afford prescription birth control,” said Cecile Richards, president of Planned Parenthood Federation of America.  “Today’s recommendation brings us a step closer to ensuring that all newly insured women under the health care reform law will have access to prescription birth control without out-of-pocket expenses.  This would be a tremendous stride forward for women’s health in this country.”

But social conservative groups said it would lead to government-sponsored abortion.

The Family Research Council, a Christian advocacy group, said including Plan B in the Affordable Care Act’s insurance coverage “essentially would mandate coverage for abortion.”

The Guttmacher Institute, a research group that advocates for abortion rights,  estimated that unintended pregnancies cost taxpayers about $11 billion per year because two-thirds of them are funded by public insurance such as Medicaid.

Other services recommended by the committee include STD and HIV counseling, gestational diabetes screening for pregnant women, counseling and equipment to promote breast feeding, screening and counseling to help prevent domestic violence, yearly preventative care visits, and human papillomavirus testing for women older than 30 to help prevent cervical cancer.

The study particularly focused on women because reproductive and gender-specific conditions lead to women using more preventative care than men on average. Therefore, women face higher out-of-pocket costs, the report noted.

Copyright 2011 ABC News Radio

Monday
Feb282011

Drug Maker Wants to Lift Age Restrictions on Morning After Pill

Photo Courtesy - Joe Raedle/Getty Images(WASHINGTON) -- Teva Pharmaceutical Industries Ltd., the maker of Plan B One-Step, has requested that the U.S. Food and Drug Administration switch this "morning after" pill to full nonprescription status for women of all ages.

Currently, women 17 and older can buy the high-dose birth control pill over-the-counter, without a prescription.  Those younger than 17 need a prescription to obtain the high-dose hormone pill.

"Our 2003 Plan B application and our current application for Plan B One-Step is seeking over-the-counter status for the product based on data that demonstrate the product meets the scientific criteria that the FDA has established for over the counter products," said Denise Bradley, senior director of corporate communications at Teva Pharmaceuticals.  "Label comprehension and safety data show that all women are able to safely and effectively take this product.  It is not typical for any women's health product to have age restrictions."

Plan B, or levonorgestrel, is a progestin-only emergency contraceptive that can prevent a fertilized egg from attaching to the wall of uterus if taken within 72 hours of unprotected sex.  The drug is not effective if the woman is already pregnant, and it does not pose harm to a fetus.

According to Jeff Ventura, a spokesman for the FDA, a prescription drug may be eligible for over-the-counter status if it is determined that dispensing the drug by prescription is not necessary for the protection of the public health, and the drug is safe and effective for use in self-medication as directed in proposed labeling.

"The application will go through the normal FDA review process," said Ventura in a statement.  "It will be evaluated against the same scientific and regulatory criteria as all other over-the-counter switch applications."

Copyright 2011 ABC News Radio