The labeling of the abortion pill has just been relaxed by the FDA. This is a big win for abortion right advocates who had for years been arguing in Ohio, Texas and North Dakota that mandated providers follow requirements on the original FDA labels on the drug when performing abortions medically. Many healthcare providers found that the original labeling of the medication was based on clinical evidence obtained nearly 3 decades ago and went against present day medical practice. Further the rigid labeling also made it more difficult for women to get abortions.
The relaxation of the rules lower the number of visits women have to make to a doctor for their abortion and also increase the number of days the medication can be used to induce abortion from 49 to 70 days, after the onset of her last menstrual period. The new labeling also sees a decrease in the drug dosage of mifepristone from 600 mg to 200 mg. Medical experts had complained to the FDA for years that the previous dosage was very high and associated with adverse effects.
In 2011, medication assisted abortions accounted for nearly 25% of all abortion in the USA and this is a major step in making easy access to medication for abortion, instead of surgery. Mifepristone, previously known as RU-486 was first approved in 2000 by the FDA. It acts by blocking the progesterone receptors, which is a critical hormone for maintenance of the pregnancy. It is often combined with misoprostol to induce miscarriage. Unlike the morning after pill which prevents pregnancy, mifepristone induces an abortion.
Universally, almost all obstetricians are pleased with this relaxation in labeling of mifepristone because the older labeling did limit a significant number of women from getting a medical abortion.
The older labeling on mifepristone were based on clinical trials done 25 years ago and since then newer clinical evidence showed that a lower dose of mifepristone could be safely taken by women for up to 70 days after the last day of the menstrual period.
Currently, the subject of medical abortion is a contentious topic in many states, who have continued to use drug regimens based on very old data. Planned parent-hood which had fought with many states is very pleased with the new FDA relaxation in labeling, adding that there will now be less confusion among healthcare professionals.