Wednesday, May 1st, 2013
The birth control medication known as the “morning-after pill” will soon be available without a prescription to women age 15 and older, the Food and Drug Administration announced Tuesday. More from CNN.com:
This move comes just weeks after a federal judge in Brooklyn, New York, ordered the FDA to make the morning-after birth control pill available to women of any age, without a prescription. Tuesday’s FDA announcement, which pertains to an application from Teva Women’s Health, Inc., is not related to that, the FDA said.
“The FDA’s approval of Teva’s current application for Plan B One-Step is independent of that litigation and this decision is not intended to address the judge’s ruling,” the FDA said in a statement.
In early April, the U.S. Justice Department indicated an appeal of the Brooklyn judge’s order was under consideration. “The Department of Justice is reviewing the appellate options and expects to act promptly,” department spokeswoman Allison Price said.
According to the new FDA decision, Plan B One-Step will now be labeled to reflect that proof of age is required to purchase it, and it cannot be sold where age cannot be verified. The packaging will include a product code that prompts the cashier to ask and verify the age of the customer.
The product will be available in retail outlets with pharmacies, but the pill can be sold during non-pharmacy hours, too.
“While we fully support this expansion of access to birth control, we continue to believe that the administration should lift all unnecessary restrictions to emergency contraception, consistent with the prevailing science and medicine,” Planned Parenthood Federation of America President Cecile Richards said Tuesday in a statement.
The FDA decision does not pertain to the two other emergency contraceptive drugs marketed in the United States. Plan B is available from generic manufacturers over-the-counter for women 17 and older and Ella is available by prescription only, for all ages, and prevents pregnancy within five days of unprotected sex or contraceptive failure.
Thursday, April 11th, 2013
A new research study published in the journal Obstetrics and Gynecology has found that intrauterine devices, or IUDs, are safe and effective for teenage girls. The findings are based on analysis of more than 90,000 women who used the contraceptive device. More from Reuters:
Researchers found less than 1 percent of all women developed serious complications from the devices, such as pelvic inflammatory disease, regardless of their age.
And teens were only slightly more likely than older women to lose their periods or become pregnant while using an intrauterine device (IUD), according to findings published in Obstetrics & Gynecology.
“It shows exactly what many of us have thought all along, that IUDs are great options for teens,” said James Trussell, who studies birth control methods at Princeton University in New Jersey.
IUDs include the hormone-releasing Mirena, which can prevent pregnancy for five years, and a copper version, sold as ParaGard, which is effective for 10 years. The devices cost a few hundred dollars each, not including doctors’ charges for inserting them.
Evidence has been mounting that new IUDs are safe and effective in preventing pregnancy. But some doctors have been difficult to convince since an older and badly-designed version of the IUD, the Dalkon Shield, caused serious infections and even deaths in the 1970s.
In guidelines published last year, the American College of Obstetricians and Gynecologists said IUDs and contraceptive implants should now be considered one of the best birth control options for teens because they are reliable and reversible.
Image: Teenage girl and her doctor, via Shutterstock
Monday, January 28th, 2013
A number of religious organizations are filing lawsuits to challenge the provision of the new health care law that requires employers to cover birth control in their health plans. The flurry of lawsuits may mean the question will eventually be presented to the U.S. Supreme Court, legal analysts are saying. The New York Times reports:
In recent months, federal courts have seen dozens of lawsuits brought not only by religious institutions like Catholic dioceses but also by private employers ranging from a pizza mogul to produce transporters who say the government is forcing them to violate core tenets of their faith. Some have been turned away by judges convinced that access to contraception is a vital health need and a compelling state interest. Others have been told that their beliefs appear to outweigh any state interest and that they may hold off complying with the law until their cases have been judged. New suits are filed nearly weekly.
“This is highly likely to end up at the Supreme Court,” said Douglas Laycock, a law professor at the University of Virginia and one of the country’s top scholars on church-state conflicts. “There are so many cases, and we are already getting strong disagreements among the circuit courts.”
President Obama’s health care law, known as the Affordable Care Act, was the most fought-over piece of legislation in his first term and was the focus of a highly contentious Supreme Court decision last year that found it to be constitutional.
But a provision requiring the full coverage of contraception remains a matter of fierce controversy. The law says that companies must fully cover all “contraceptive methods and sterilization procedures” approved by the Food and Drug Administration, including “morning-after pills” and intrauterine devices whose effects some contend are akin to abortion.
As applied by the Health and Human Services Department, the law offers an exemption for “religious employers,” meaning those who meet a four-part test: that their purpose is to inculcate religious values, that they primarily employ and serve people who share their religious tenets, and that they are nonprofit groups under federal tax law.
Image: Lawsuit paperwork, via Shutterstock
Friday, January 11th, 2013
The Food and Drug Administration has approved a new intrauterine device (IUD), the first such new approval in 12 years, Reuters is reporting:
The T-shaped polyethylene device is designed to prevent pregnancy for 3 years, during which time it releases a diminishing dosage of progestin, according to Bayer documents.
The proportion of women using long-acting reversible contraceptive methods such as an intrauterine device (IUD) climbed to 7.7 percent in 2009 up from 2.0 percent in 2002, according a 2012 study by the Guttmacher Institute, a reproductive health and rights organization based in New York.
The highest level of use was among women aged 25-39 and those who already had at least one child.
The IUD, called Skyla, is aimed at younger women who have not had children. During a trial of 1,432 women aged 18 to 35 years, the rate of pregnancy over a three-year period was 0.9 per 100 women, and 77 percent of women wishing to become pregnant did so within 12 months of its removal, Bayer documents said.
“Over half of all pregnancies in the U.S. are unintended and there’s just a need out there to have effective birth control,” said Pamela Cyrus, Bayer’s head of medical affairs said in an interview.
Image: Woman talking to her doctor, via Shutterstock
Tuesday, November 27th, 2012
The American Academy of Pediatrics is revising its policy on contraception, now recommending that pediatricians should discuss safe sex and contraceptive options including the “morning-after” pill Plan B with teenaged patients and their parents. Further, the AAP is recommending pediatricians prescribe a “just-in-case” Plan B prescription teens can carry in their wallets. More from CNN.com:
The United States has one of the highest rates of teen pregnancy among developed countries. Nearly 80% of teen pregnancies are unplanned, a result of contraception failure or nonuse, according to the AAP.
The use of emergency contraception has been around since the 1970s, when doctors often advised patients to double up on their regular birth control pills in a method called “Yuzpe.” Since then several products have been approved for use by prescription and over-the-counter. Yet lead author Dr. Cora Beurner said there are still many people who don’t know about emergency contraception or have unfounded fears about using it.
Emergency contraception is designed to prevent pregnancy after unprotected sex. It works by inhibiting ovulation and disrupting the production of key cells needed in a woman’s body to conceive. It works best if taken up to 24 hours after intercourse, although it lowers pregnancy risk if taken within 120 hours (five days). It will not work if you are already pregnant.
Emergency contraception is available with a prescription for all patients and available over-the-counter for women over the age of 17. The pills cost around $80.
Image: Teenage girl with doctor, via Shutterstock