Abortion Pill over the Counter
According to the FDA, one of the most dangerous drugs for selling in retail pharmacies is the Mifeprex (American company name for Mifepristone). According to experts, it can only be released in private practice and specialized approved hospitals and clinics.
Today, the movement in the area of women's reproductive health is growing and the number of requests and attacks on the access to abortions is increasing. Therefore, the FDA is compelled to allow doctors the distribution of the drug Mifeprex. Some medical experts and drugstore associations note that the requirements for limitations of abortions are not justified at the present time. Moreover, some countries have abandoned them.
Clinical studies held with the drug Mifepristone were carried out in the mid-nineties, and some doctors in Europe have started prescribing it to their patients since 1988. But the controversy surrounding the drug was due to the ambiguous attitude of the public towards abortions.
There is also a drug Suboxone, which is used for an opioid dependency treatment. It causes addiction. This drug has REMS. Another drug is Accutane. It is used against strong acne and skin problems. Its taking can cause side effects, such as hepatic insufficiency and birth defects.
There are other substances, which have REMS: the drugs against cancer, rare blood diseases, psychosis and the drugs that can cause internal bleeding or breathing stopping. These drugs are very dangerous, but despite this, they are sold in retail pharmacies. Such medications can sometimes even cause immediate side effects that require urgent hospitalization.
The drug Mifeprex is not intended for the treatment of severe diseases or life-threatening conditions. Complications are extremely rare. Mifeprex usually does not require any monitoring. Usually, a two-week control should be conducted to ensure that the pregnancy is completely stopped and further visits to the doctor are not necessary.
There are not many medications that are the subject of controversy and numerous discussions. Preservation and distribution of the drug Mifeprex also requires a competent advice and approval from medical experts and lawyers.
Approval of this drug is unlikely in the case if even one of the experts in the process doesn’t want to generate the anger and disapproval among anti-abortion activists, or if he himself is against abortions and doesn’t want to approve the drug. This situation is observed in many clinics in many countries where there is a very strong mood against abortions and the doctors working there will not even try to discuss the approval of the drug Mifeprex.
The group of gynecologists and the manufacturer of Mifeprex in 2016 advocated making a review of the need for REMS. They received a response that the drug
Mifeprex has its advantages, the side effects, associated with its intake are very rare, but the limitations on this drug remain unchanged.
There is a possibility that by the year 2019 a study will begin that will allow the drug Mifepristone to be taken by pharmacies.
In 2016 Australia made some changes, four years after the occurrence of the drug. Canada made the drug Mifepristone available in 2017 and in less than a year allowed it to be sold in pharmacies.
REMS do not apply to the second step of the abortion, the drug Misoprostol, which is taken to complete the abortion process 24-48 hours after taking the drug Mifeprex. Misoprostol can be bought freely at pharmacies and taken at home.