FDA rectifies its requirements for abortion pill


Posted October 3, 2016 by safeabortionpillrx

The FDA approved updated labeling for medical abortion pill, ‘Mifeprex’ commonly known as Mifepristone. This is an important move for appropriate usage and improving Risk evaluation and mitigation strategy (REMS).
 
3rd October 2016
The US Food and Drug administration, in an important move relaxed its guidance for using medical abortion pills. The drug in question, Mifeprex was first approved by the FDA in the year 2000, although its dose requirement, regimen and labeling etc were only recently amended.
The FDA notified the drug manufacturing company in a letter stating that it’s safe for use and effective in aborting pregnancy. Mifeprex is mostly known as Mifepristone and RU-486.
What is it?
It is used for terminating pregnancy in its early stages without using surgical methods. Along with Misoprostol, Mifeprex is used an anti-progesterone pill that block the hormones from forming a uterine lining that continue pregnancy. You may acquire Mifeprex online or at a local clinic.
What does this change mean?
Under the new label, Mifeprex usage has been extended, now it can be used within 10 weeks (70 days) of gestation, compared to FDA requirement of using it within 7 weeks (49 days) before the amendment.
Under the rules, Mifeprex dosage recommendation has changed to smaller dose (600 mil to 200 mil) as the previous dosage was considered too high by medicinal societies and pro-choice advocates. Along with dosage requirement, the technique of administering it was also modified. That means the tablet which was before required to take orally will now be required to take buccally, i.e. in between the teeth and cheek. The interval in between taking Mifepristone and Misoprostol has also changed, as well as the process of check up after taking the drug.
In addition to this, FDA also revised its labeling requirements, thus changing Mifeprex’s current labeling. The existing Risk evaluation and mitigation strategy has also been modified making its REMS consistent and for better supplemental application
Change angers pro-life supporters
This decision as expected rankled the pro-life groups and law makers in states with restrictive abortive laws.
One such anti-abortion rights group stated that FDA’s new laws won’t make women safer. The FDA’s protocol only caters to abortion industry to increase its consumer base and profits. It helps them reduce their expenditure with decreasing the staff and time/resources given to the patient, stated a spokesperson.

Abortion right groups approve
The change was welcomed by pro-choice groups as the FDA laws will also affect North Dakota, Ohio were the off-label use of the drug is banned. Similarly the law will also be applicable to Oklahoma, Arkansas and Arizona etc.
As the new label will make it easier for women to use it as well as widen the duration for using it, it will reduce the number of trips women will have to take to the clinics.
How can acquire it
The drug is available worldwide and is approved by sixty countries including France, USA, Denmark, United Kingdom, Scotland etc.
With online retail business taking over medicine industry, you can now buy Mifeprex online in the privacy of your home. With amended FDA requirements, it is necessary to follow the updated guidelines for using it.
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Last Updated October 3, 2016