Press Release Material still published and referred by media and clinics
Here is my translation of the MHLW's press release material in 2004. The original material is in Japanese.
https://www.mhlw.go.jp/houdou/2004/10/h1025-5.html
October 2004 ＜Press release material
Topics
October 25, 2004
Ministry of Health, Labour and Welfare
Surveillance Guidance and Narcotics Control Division
Mitsuoka (Ext. 2763)
Morita (ext. 2762)
Oral abortion pills imported by individuals (so-called oral abortion pills)
Oral abortion pills, which are not approved in Japan, are known to cause bleeding that sometimes requires surgery, and even in Europe and the U.S., they are drugs that require a doctor's prescription and follow-up care.
Therefore, the Ministry of Health, Labor and Welfare has decided to call attention to the dangers of personal use of these drugs without consulting a medical facility on its website and through the media. At the same time, we have decided to take the following measures to ensure that the drug is not imported and used easily by individuals:
1 Alert through the Ministry of Health, Labor and Welfare's website
(1) The Ministry of Health, Labor and Welfare (MHLW) has decided to post a Q&A on its website to widely urge people to avoid taking oral abortion pills without consulting a medical facility, as it is dangerous to do so.
(2) We have requested cooperation from the Japan Medical Association and other related organizations in order to understand the current state of health hazards and to promote alert measures. (Reference)
2 Strengthening of Monitoring and Guidance for Personal Import Agents
Even if a company claims to be a personal import agent, there is a risk that it may be in violation of the Pharmaceutical Affairs Law, depending on the form of the advertisement, for example, by soliciting the wishes of an unspecified large number of people.(1) Request each prefectural government to thoroughly monitor and provide guidance on the Internet advertising of personal import agents.
(2) Send warning e-mails to personal import agents and providers that advertise on the Internet.3 Restrictions on Personal Importation
The handling of oral abortion pills, which previously could be imported by individuals in small quantities without procedures at the Ministry of Health, Labor and Welfare, has been changed. From now on, the MHLW has decided to restrict personal importation so that, in principle, importation will be possible only when the local health and welfare bureau has confirmed that it is based on a doctor's prescription.
(Reference) Product names and other information on oral abortion pills for which personal importation is restricted and for which attention should be paid
Generic name: Mifepristone
Trade name:
(EU) Mifedine (Mifegyne)
(US) Mifeprex (Mifeprex)
(China) See-In
(Taiwan) Apano (added in May 2008)
Also known as "RU486" at the time of development.
Q&A regarding the oral abortion pill "RU486" or "Mifepristone Tablets
Q1. What kind of drug is "RU486" or "Mifepristone (mifepri- stone)", which is considered an oral abortion drug? Are they approved in Japan?
A1. RU486 or Mifepristone is an abortion pill that stops the action of the hormone progesterone, which is necessary for a pregnancy to continue.
It is an unapproved drug in Japan, and its transfer and sale are prohibited by the Pharmaceutical Affairs Law.
The active ingredient "Mifepristone" is approved in Europe and the United States as a drug that can terminate a pregnancy within 49 days of conception (from the start of the last menstrual period) when used with other drugs that cause uterine contractions, and a physician is required to use it and monitor its progress.
Q2. How is "Mifepristone" regulated in the U.S. and Europe? Can I import it by myself?
A2. In Europe and the United States, Mifepristone is a drug that can only be prescribed by a physician. The possibility of vaginal bleeding, serious infections, etc. is known, and it is necessary for a physician to monitor the patient after administration and to be able to visit a medical institution in case of an emergency. Even in Europe and the United States, the drug cannot be purchased at pharmacies without a doctor's prescription. It is also not allowed to be sold through the Internet.
In addition, because the drug is ineffective against tubal pregnancies (ectopic pregnancies) and there is a risk of tubal rupture if it is not noticed and appropriate measures are not taken, a warning has been issued to medical institutions in the United States.
For these reasons, it is dangerous to obtain this drug through a private import agent on the Internet and use it for personal use, so please do not do so.
Q3. In what cases is Mifepristone prohibited in foreign countries?
A3. Mifepristone is not indicated for use in cases where it has been taken for more than 49 days since the beginning of the last menstrual period. In addition, the following patients should not take the drug
- Tubal pregnancy (ectopic pregnancy)
- Intrauterine device (IUD) users
- Patients with adrenal gland disorders
- Patients receiving steroid medication
- Patients with abnormal bleeding or on anticoagulants
- Allergic reactions to Mifepristone, Misoprostol, or similar medications.
Q4: What are the possible side effects or health hazards associated with Mifepristone?
A4. According to the foreign package insert, Mifepristone can cause vaginal bleeding. Occasionally, vaginal bleeding can be very heavy and in some cases requires surgical intervention to stop the bleeding.
In addition, in November 2004, the United States added to the warning section of the package insert the possibility of serious bacterial infections such as sepsis and rupture of the fallopian tubes when administered to patients with ectopic pregnancies.
Other known side effects include diarrhea, nausea, headache, dizziness, and lumbar back pain.
(Reference) Brand name and other information on oral abortion pills for which personal importation is restricted and for which attention should be paid
Generic name: Mifepristone
Trade name: Mifepristone (EU) Mifepristone (EU) Mifedine (EU)
(EU) Mifedine (Mifegyne)
(US) Mifeprex (Mifeprex)
(China) See-In
(Taiwan) Apano (added in May 2008)
Also known as "RU486" at the time of development.
