New emergency contraceptive approved by FDA

The newest form of emergency contraceptive, ellaOne, was approved August 13 by the U.S. Food and Drug Administration.

Although the new drug has been around since fall of 2009 in select European countries, it was not introduced to the United States until June 2010.

The new drug is a type of emergency contraceptive pill that allows a woman up to five days after sexual intercourse to consume the pill.

The more popular contraceptive pill, Plan B One-Step, also known as the morning-after pill, offers only three days.

"The great thing about ellaOne is the efficacy lasts for all five days," said Morgan Molnar, '10, a marketing major pursuing her masters in sociology, who attended part of the first FDA hearing in June about ellaOne.

"The effects of the pill will be the same if you take it on the first day or the last day," she said. "If you take Plan B One-Step the day after unprotected sex, you will have a better chance of not getting pregnant than if you took the pill three days later. EllaOne lasts all five days and your chances don't decrease."

However, like most new drugs, long-term effects are unknown for ellaOne.

"As far as my opinion, it's a great drug, but my only concern is that it is so new," Molnar said. "They haven't done too many long-term studies, so in the case that women have become pregnant and have taken the drug, they don't know what will happen to the unborn fetus."

"Plan B One-Step doesn't have a lot of effects on the fetus, but ellaOne is so new that they are unsure of its effects in the long run," she said.

Susan Kitei, director of the Health Center, said she is not ready to endorse ellaOne because significant problems with a new medication are not always apparent until it has been widely used for two to five years.

"This is why, occasionally, we will hear on the news that a drug is being removed from the market," she said. "EllaOne has been used in Europe only since 2009, so it is wisest to wait a while to make absolutely certain it is as safe as other medications used for emergency contraception. The best alternative, Plan B, has been in wide usage for a number of years and is known to be safe and effective."

Kitei also said Plan B is available without a prescription for those 17 years and older.

The new drug will be prescription-only, and how its cost will compare with Plan B is still unknown.

"Since the decision of taking emergency contraception is such a big choice for women, this now gives them more time to make a good decision of whether or not they want to pursue with emergency contraception," Corry Starr, '13, said. "However," she said, "since ellaOne has to be prescribed, I don't think girls will want to use it as often as Plan B due to confidentiality."

"Based on what I saw, it looks like ellaOne is more effective than Plan B," Rita Jones, director of the Women's Center, said.

"It's advantageous because it offers women five days opposed to three days," she said.

"However, women should still think about securing emergency contraception as soon as possible. Just because they now have three to five days, doesn't mean they should simply wait around."

Karen Hicks, an adjunct professor of women's studies and sociology, also attended part of the first FDA hearing and recommended getting as much information as possible before using the medication.

"Time will tell how popular ellaOne will be in the U.S.," Kitei said. "The more educated a woman is, the less likely she is to need it. Because most of our students are aware of Plan B, I am expecting only rare requests."

Jones considered a separate advantage of the new drug and said the availability of the new drug is a benefit in cases of incest or sexual assault.

"In some incidents, the survivor might need a couple of days to process what happened," she said. "Five days provides more time for the survivor and helps them, as opposed to a smaller three-day window."

The price of ellaOne has yet to be determined in the United States but according to Molnar, it will be about three times the price of Plan B.

"I think the approval of ellaOne was definitely a step in the right direction toward giving women more choices," Molnar said.

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FDA approves new oral contraceptive

The U.S. Food and Drug Administration, FDA, has approved a new oral contraceptive for women called Natazia. The new drug contains two female hormones, estrogen and progestin.

Scott Monroe, M.D., director of FDA's Division of Reproductive and Urologic Products reports, “Nearly 12 million women in the United States and more than 100 million women worldwide currently use oral contraceptives. The approval of Natazia provides another option for women who choose to use an oral contraceptive as their method of contraception.”

The most common side effects include irregular bleeding, breast tenderness, headaches, nausea, vomiting, increased weight, and acne. Women over 35 years of age who smoke are being advised to not use Natazia. Evidence has shown that cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use.

In Michigan, over one million women are in need of contraceptive services and supplies. Over 213,000 of the over 2 million women of childbearing age become pregnant each year. Natazia becomes another choice women can make in contraception use.

Manufactured by Bayer Schering Pharma, Natazia is expected to be available by this summer in the U.S.

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New Contraceptive Ring May Prevent HIV-Aids

The next generation of birth control devices may not only prevent pregnancy without the need for hormonal compounds, but also protect a woman from becoming infected with the deadly HIV-AIDS virus.

This is great news for women who have latex allergies or those women who prefer not to use hormonal based contraceptives.

A team of researchers from Weill Cornell Medical College has developed a contraceptive ring that blocked transmission of the HIV virus in laboratory tests. The contraceptive ring time-released multiple antiviral drugs over a period of 28 days, which have been shown to prevent HIV infection.

The drugs used are, a new anti-HIV agent, named Boc-lysinated betulonic acid, TMC120 or dapivirine, PMPA, and 3′-azido-3′-deoxythymidine or AZT/zidovudine.

Combining these particular antivirals together forms a powerful barrier to HIV infection. The researchers exposed human cells to the HIV infection in the laboratory and the antiviral drug cocktail successfully blocked the infection. The new ring device was also successfully tested on animals in a laboratory setting.

The contraceptive ring also makes use of groundbreaking methods in preventing pregnancy, without the use of hormones or spermicides. Hormones have been linked to an increased risk for breast and cervical cancer and spermicides can cause irritation.

The researchers solved these problems by using instead, compounds that arrest sperm motility, raise vaginal mucous viscosity and raise the acidity of the vagina to a level where sperm can’t survive.

Head researcher, Dr. Brij Saxena, Professor of Reproductive Biology and endocrinology at Weill Cornell Medical College, noted, “this is the first device to simultaneously offer the possibility to prevent unintended pregnancy and HIV transmission.”

With nearly 5 million people infected every year with the HIV-Aids virus, causing 3 million deaths, worldwide, this new contraceptive device can save lives by offering women another option in HIV-Aids prevention, besides abstinence and the use of latex condoms.

With additional testing, the contraceptive ring could also be used to prevent other sexually transmitted diseases.

The study is available in the recent edition of the Aids Journal.

Source : chattahbox.com

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