FDA approves 5-day 'morning-after' pill

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La FDA approuve de cinq jours « matin-après » la pillule

par Heather Mayer, DOTmed News Reporter | August 16, 2010
Ella was available
in Europe last
year.
Step aside, Plan B emergency contraception. There's a new girl in town. The U.S. Food and Drug Administration approved an emergency contraception pill, ella, on Friday. The pill works longer than the leading "morning-after" pill.

The HRA Pharma contraceptive can prevent pregnancy up to 120 hours, or five days, after unprotected intercourse or a known contraceptive failure. But the leading "morning-after" pill, Teva Pharmaceutical's Plan B, only can prevent pregnancy up to 72 hours, or three days, after unprotected sex.

"The current methods are not satisfying the current need," Erin Gainer, CEO of France-based HRA Pharma, told DOTmed News by phone. "The idea here is [ella] is another option, another tool, for women to use."

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Unlike Plan B, ella has only been approved for prescription-only purchase. The company did not seek over-the-counter status for ella, because it's a new drug, and traditionally, new drugs are not available over the counter right away, Gainer explained. She said it's too early to say whether the company will seek over-the-counter status.

Plan B and other generic emergency contraceptives became available over-the-counter for girls and women ages 17 years and older last year.

In a head-to-head trial between ella and Plan B, women who took ella had a 1.8 percent chance of becoming pregnant, and women who took Plan B had a 2.6 percent chance, according to numbers from Lancet.

The pill works by delaying ovulation, not terminating a pregnancy, which some critics claim to be the case. The Family Research Council criticizes the FDA for calling the pill an emergency contraceptive, saying the label is deceiving.

"The FDA opted against including the critical fact that ella can cause an abortion on a baby already implanted in its mother's womb in the drug labeling information," said Jeanne Monahan, director of the Center for Human Dignity at the Family Research Council, in prepared remarks.

But that's not true, the drug's manufacturers said. In fact, clinical trials on pregnant animals showed "no indication of signs of malformation or anything like that," said Gainer.

There were several women in the clinical trial who did not know they were pregnant and tested ella. There were no signs of any problems, said Ganier.

FDA spokeswoman Elaine Gansz Bobo told DOTmed News there is "absolutely no reason to be concerned" if a woman takes ella and is unknowingly pregnant. She also pointed out that emergency contraception and abortion pills work completely differently, much of it based on the timing of when a woman takes either pill.

Watson Pharmaceuticals, based in New Jersey, will market the drug, expected to see shelves before the end of the year, said Ganier. The pill has been available to the European market since October 2009, called ellaOne.