The U.S. Food and Drug Administration approved an extension for the use of abortion drug Mifeprex up to 70 days of pregnancy on Tuesday from a previous limit of 49 days despite possible health risks, including death.
Mifeprex, also known as mifepristone, blocks a hormone called progesterone that is needed for a pregnancy to continue according to the FDA. When used together with another medicine called misoprostol, the FDA says it can end an early pregnancy 70 days or less since the first day of the last menstrual period.
Mifeprex was first approved by the FDA in 2000 when it was also known as RU-486. On Tuesday the agency approved a supplemental application submitted by the drug company that markets Mifeprex which includes decreasing the dose of Mifeprex and the dosing regimen for taking Mifeprex and misoprostol along with the age of the pregnancy. Danco Laboratories, a New York firm with an unlisted phone number and address is the U.S. distributor of Mifeprex, according to CBS News.
"The approval also modifies the gestational age up to which Mifeprex has been shown to be safe and effective, as well as the process for follow-up after administration of the drug. In addition, the labeling has been revised to meet the current labeling requirements in the FDA's regulations," said the agency in a statement.
Randall K. O'Bannon, director of education & research at the National Right to Life organization said in a statement Wednesday that the changes approved by the FDA only benefit the drug company and charged that at least 14 deaths have stemmed from the use of Mifeprex.
"Many suspected that today's announcement by the FDA was a long time coming. Despite a record of at least 14 known deaths, and thousands of women suffering significant adverse events, the FDA relaxed safety standards and modified the protocol for mifepristone/misoprostol chemical abortions that had been in place since September of 2000," O'Bannon began.
"Though applauded by the abortion industry, the documentation demonstrating the impact on women's safety has not been made publicly available. Certainly, none of the modifications is of any benefit to the unborn child. For women, the mifepristone/misoprostol combination comes with significant cramping, bleeding, and other gastrointestinal side effects (nausea, vomiting, diarrhea) that are expected parts of the chemical abortion process," he added.
The FDA lists death among the serious adverse effects reported by users of Mifeprex on its website but says it is unclear whether these deaths are related to use of Mifeprex and misoprostol.
"The FDA has received reports of serious adverse events in women who took Mifeprex. The reports in women who took Mifeprex include one case of ectopic pregnancy resulting in death; several cases of severe systemic infection (also called sepsis), including some that were fatal; and a single case of non-fatal heart attack. At this time, it is unknown whether there is a causal relationship between any of these adverse events and the use of Mifeprex and misoprostol," the agency said.
"In the end, it is obvious that the FDA's new protocol serves only the interests of the abortion industry by expanding their base of potential customers, increasing their profit margin, and reducing the level of staff and amount of resources they have to devote to the patient. It is clear whose interests it is the FDA is serving. It isn't the women, and it isn't the babies," said O'Bannon.
The Catholic Association agrees with O'Bannon.
"Changing the rules for the abortion drug mifepristone thereby allowing its use through up to 70 days of gestation (previously 49 days) is a substantial difference. The FDA has bowed to pressure from drug companies and abortion advocates, but the ones who will feel the deplorable effects of this change will be the women sent home to endure a painful and shocking process by themselves and of course their babies," Dr. Grazie Pozo Christie, advisory board member with The Catholic Association said in a statement Thursday.
"As a radiologist who performs fetal ultrasound every day, I can say that a 10 week old fetus is a well-developed and recognizably human creature. Head, hands, feet, and vigorous movement are evident even to the untrained eye. Also at issue is the psychological and physical impact on a woman, sent home to experience the very painful cramps of a chemical abortion of a fetus that size. Besides the considerable blood loss and pain, there is every chance of a woman recognizing a fully formed fetus amongst the expelled 'products of conception,'" she added.