New FDA Guidelines Ease Access to Abortion Pill

     (CN) – The Food and Drug Administration on Wednesday relaxed guidelines for taking a medication that induces abortion, allowing women to use the drug further into their pregnancies – but also reviving controversy over the pill.
     The new requirements expand the period of time a woman can use mifepristone, the drug formerly known as RU-486 and marketed as Mifeprex, to induce an abortion from 49 to 70 days after the beginning of her last menstrual period.
     The drug blocks receptors of progesterone, which is a key pregnancy hormone. When combined with misoprostol to start labor the drugs cause a miscarriage when administered early in pregnancy.
     This process is an alternative to suction or surgical abortions which, in addition to emergency contraception like the morning-after pill, prevents pregnancy.
     New labeling for Mifeprex lowered the recommended dosage from 600 milligrams to 200. Doctors have argued that previous labels were out of date and physically damaging for patients, and abortion-restrictive laws in Ohio, North Dakota and Texas had forced physicians to follow the FDA labeling.
     “First and foremost, this is another affirmation from the FDA that medication abortion is a safe and effective option to end and early pregnancy,” Dr. Raegan McDonald-Mosley, chief medical officer of Planned Parenthood Federation of America, said in a statement.
     According to health experts, medication abortions are generally safe and effective.
     “Studies show medication abortion has a 99 percent safety record, and that medication abortion is up to 98 percent effective in ending an early pregnancy,” McDonald-Mosley said.
     Dr. Mark S. DeFrancesco, president of the American Congress of Obstetricians and Gynecologists, lauded the FDA’s action.
     “Access to reproductive services, including abortion care, is essential for women’s health. Medication abortion, performed through a combination of mifepristone and misoprostol, has provided a safe, effective option for induced abortion that has benefited millions of women,” DeFrancesco said in a statement.
     The FDA approved mifepristone in 2000. Its label was based on clinical trials from the 1990s, however, which experts felt were outdated based on subsequent evidence.
     This led many physicians to practice off-label usage, a medically accepted regimen that does not follow label recommendations. Their off-label prescriptions mirror the FDA’s new requirements and labeling.
     Planned Parenthood, the American Medical Association, the American Congress of Obstetricians and Gynecologists, the World Health Organizations and other health groups had previously recommended the new dosage and requirements for medication abortion.
     But off-label usage is illegal in Ohio, Texas and North Dakota, despite the recommendation of professionals. Similar laws in Oklahoma, Arkansas and Arizona have been blocked by court orders.
     “Given the restrictions on medication abortion enacted at the state level in recent years, updating the label to reflect best medical practice represents a significant step forward for science, for women, and for health care providers who want to give our patients the highest quality care,” McDonald-Mosley said.

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