OKLAHOMA CITY (AP) – The U.S. Food and Drug Administration has approved a new label for a common abortion-inducing drug that could undo restrictions on medication abortions passed by several states.
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Many doctors were already prescribing medical abortions using the new criteria before the change (this is known as off-label use), largely because the guidelines were based on what many medical professionals considered to be outdated clinical evidence from the 1990s.
“At least eight deaths have been documented of women using mifepristol for abortion, all of them using the off-label protocol that the FDA has just approved”. So, that’s less doctor visits, less time off of work and less money that women need to figure out.
This labeling change “is another affirmation from the FDA that medication abortion is a safe and effective option to end an early pregnancy”, said Raegan McDonald-Mosley, MD, chief medical officer of Planned Parenthood Federation of America, in a statement.
However, some states, including Ohio, Texas and North Dakota, still required doctors to follow the regimen on the pill’s packaging, which means that a move as simple as updated FDA labeling can make a major difference in the lives of women in states with anti-abortion laws.
One thing is very clear in the statement, do NOT buy Mifeprex over the Internet because you will bypass important safeguards created to protect your health (and the health of others). But the new label eliminates the appointment after three days, and says that a woman should return for follow-up with her health care provider seven to 14 days after taking the medication.
Mifeprex blocks progesterone receptors, cutting off the body’s access to the hormone that’s needed to maintain a pregnancy.
Under the new label, a smaller dose of mifepristone can be used up to 70 days after the beginning of the last menstrual period rather than the 49-day limit mentioned in the old label. The new changes allow women to take the pill up to 10 weeks into their pregnancy. The former FDA guidelines for mifepristone recommend a dosage of 600 milligrams, three doctor visits, and said that the drug could be taken through the seventh week of pregnancy.
These changes open up access to abortion, making it cheaper and simpler, as women have to make fewer trips to a clinic.
President of the American Congress of Obstetricians and Gynecologists Mark S. DeFrancesco said the new regimen for the pill “reflects the current available scientific evidence and best practices”.
The guideline to access a pill to induce an abortion has been relaxed by the FDA.
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The New York Times quoted Eric Scheidler, the executive director of the Pro-Life Action League, as saying, “My first thought was that this is a bone that the Obama administration was throwing out there to their friends in the abortion lobby”.
