Posts Tagged ‘food and drug administration’

Morning-after pill to be made available over the counter

Washington D.C., Apr 30, 2013 / 04:44 pm (CNA/EWTN News).- On April 30, the Food and Drug Administration approved over the counter sale of the morning-after pill Plan B One-Step to all women aged 15 and older.

Plan B One-Step is the name of the drug, made exclusively by Teva Women’s Health, Inc., which acts as an emergency contraceptive which reduces the possibility of pregnancy when taken up to three days after sexual intercourse. It is taken as a single-dose 1.5 mg tablet of levonorgestrel.

Pharmacies and retailers with on-site pharmacies will have the drug on shelves, and those wishing to purchase it will have to provide proof of age. Teva has agreed to have a security tag placed on all Plan B One-Step cartons to prevent theft, according to the FDA.

Plan B is the same drug – levonorgestrel – as Plan B One-Step, but is taken in two doses of 0.75 mg per tablet. Plan B, which is available from generic manufacturers, requires a prescription for women under the age of 17.

Ella, another emergency contraceptive, is prescription-only.

In Dec. 2011, Health and Human Services secretary Kathleen Sebelius overruled the FDA’s plan to make the morning-after pill available over the counter and with no age limits citing “significant cognitive and behavioral differences” between older adolescent girls and the youngest girls of reproductive age.

Today’s release claimed that a study submitted by Teva showed that women 15 years and older are able to understand the drug is not for routine use and does not protect against sexually transmitted diseases.

On April 5, a federal judge in Brooklyn, Edward Korman, had ordered the FDA to allow over the counter sale of Plan B to women of all ages, and/or make Plan B One-Step available without age restrictions.

The FDA said that today’s approval of Plan B One-Step is independent of Korman’s ruling, which caused outcry last month from pro-life and Catholic groups nationwide over perceived health risks to young women.

Dr. Charmaine Yoest of Americans United for Life called Korman’s decision an opportunity for “big abortion industry to gamble with young girls’ health,” and the New York Catholic Conference called the ruling a “recipe for disaster.”

Energy drink allegedly linked to one miscarriage

by Peter Baklinski FARMINGTON HILLS, Michigan, November 16, 2012, (LifeSiteNews.com) – Pregnant mothers low on energy might want to think twice before downing another bottle of 5-Hour Energy. The Food and Drug Administration (FDA) has received report…

Human trials for embryonic stem cell treatment a crime, says Bishop Sgreccia

Rome, Italy,  (CNA/EWTN News).- Following Friday’s news that a U.S. company has been given the go ahead to experiment with embryonic stem cells on human patients, a former head of the Pontifical Academy for Life told Vatican Radio that the trials are unacceptable. He said that regardless of whether the result of testing is positive [...]

FRC Action and Pro-Life Coalition Urge the FDA to Reject New Abortion-Causing Drug

WASHINGTON, DC (MetroCatholic) -  Yesterday FRC Action joined 19 pro-life groups in a letter sent to Food and Drug Administration (FDA) Commissioner Margaret Hamburg requesting that Ella, a drug under consideration for FDA approval that can cause abortions but is misleadingly labeled as an “emergency contraceptive,” not be approved. Tom McClusky, FRC Action’s Senior Vice President, made [...]

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