South Korean FDA drops prescriptions for emergency contraception
June 8, 2012 (HLIWorldWatch.org) - The Korean Food and Drug Administration (KFDA) announced Thursday that the purchase of emergency contraceptives, known as morning-after pills, will no longer be regulated by medical doctors, and the drugs will now be available over-the-counter (OTC).
The KFDA also reversed its policy on non-emergency oral contraceptives, announcing that purchase will require a doctor’s prescription beginning as early as next year. The pills are currently available OTC except for Bayer’s Yasmin and Yaz brands, which have been under investigation by the U.S. FDA for elevated risk of blood clots. A prescription for emergency contraceptives will still be required for teenagers.
“According to our panel of experts, the main mechanism behind the emergency pills is the interference of hormonal action, linked to interference of implantation. It is not an abortion,” said Cho Ki-ho, a KFDA official.
The Korea Herald reported that Catholics in Cheongju, North Chungcheong Province, held a protest in front of the KFDA headquarters prior to Thursday’s announcement urging authorities to maintain the current classification of the drug.
Bishop Gabriel Chang Bong-hun of Cheongju, president of the Committee for Bioethics of the Catholic Bishops’ Conference of Korea (CBCK) argued fiercely against reclassifying emergency contraceptives as OTC drugs in a May 6, 2012 letter:
“The Korean Pharmaceutical Association (KPA) and some NGOs have argued recently that the morning-after pill should fall under the category of an over-the-counter drug because it can cut the abortion rate. … For the last thirty years the government in promoting a policy to curb overpopulation has played a decided role in the diffusion of contempt for life and the infringement upon the dignity of human life, because it has overlooked and even encouraged the practice of unethical artificial contraception and abortion. As a result, our society is now facing a serious low birth rate.”
The bishop called the use of artificial contraception “an ethically unjustifiable act” and argued that the morning-after pill “is also a kind of contraceptive infringing upon human life.”
“Blessed Teresa of Calcutta said that abortion is the most severe violence against the peace of the world,” he said. “Just as we cannot tolerate visible school violence, so we cannot tolerate the invisible violence of abortion and the morning-after pill.”
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The Korean Pharmaceutical Association (KPA) issued a statement last week urging the government to list emergency contraceptives as OTC drugs, and claimed deregulation would decrease the number of illegal abortions in South Korea.
“Emergency pills are effective when taken within 12 hours of sexual intercourse and 72 hours utmost. Finding and visiting a doctor in that limited time is very difficult,” the KPA said.
“In a way, conventional pills are much riskier,” said Kim Koo, head of the KPA. “Long-term exposure to oral contraceptives is much more harmful. Think of it, your hormone secretion is being manipulated regularly for years. But many of them are sold without doctors’ prescription.”
The KFDA recognizes that the side effects of oral contraceptives can include thrombosis, thromboembolism, thrombo puerperalis, myocardial infarction, cerebral hemorrhage and cerebral thrombosis, among others, and bans the pills from being administered to women with breast cancer, endometrial cancer, hepatitis and thromboembolism. Women who are over 40 years old, obese, have headaches, depression or other related conditions are also restricted from obtaining the pills.
“In order to prevent pregnancy, women are advised to take the pills for 21 days a month then take a seven-day break. This pattern goes on forever. It affects the hormonal activities of the body. We need a careful approach to the issue,” the KFDA’s Kim Sung-ho said.
But when it comes to emergency contraceptives, KFDA authorities do not appear to be concerned about harmful side effects. The cited reason for the lack of concern was that health officials have not observed many of the more serious side effects in Korean women: “The most commonly reported side effects of the drug, including irregular menstruation, headache, nausea and vomiting, are reported to cease within 48 hours. Thromboembolism and other serious adverse effects have not yet been reported in Korea.”
The Korean Society of Obstetrics and Gynecology warned of the harmful side effects of emergency contraception in a statement released prior to the KFDA ruling in which the group argued to keep the current restrictions in place.
“Emergency pills shift the hormonal action of the body to an extreme level since it should be able to prevent conception. The hormone contained in the drug is 10-15 times stronger than regular pills. Then how critical can that be? It naturally requires doctors’ consideration and monitoring,” said Chung Ho-jin of the Korean Society of Obstetrics and Gynecology.
The group also did not agree with claims that greater access to emergency contraceptives would curb the number of abortions: “In Sweden, the morning-after pills were reclassified as OTC from 2001. By 2007, the abortion rate increased by 17 percent. The more important thing is that the failure rate of the abortion pills is more than 15 percent, which shows that the drug is not a cure to irresponsible sex.”
The Catholic Church in South Korea is not likely to relent in its opposition to the government’s action on contraceptives. In an effort to strengthen the clergy’s understanding of life and family issues, Bishop Gabriel Chang Bong-hun recently commissioned the translation of Human Life International’s A Pro-Life Pastoral Handbook, and sent copies to every priest in South Korea. The publication was specifically designed to help priests, seminarians and other religious and lay teachers of the Catholic faith examine questions about contraception, abortion, end of life issues, assisted reproductive technologies, and the Sacrament of Marriage.
“The KPA and pharmaceutical companies must have deep concern for health and sound sexual morals of the youth and not just focus on their profits,” said the bishop in May. “[T]hough it is a long and difficult way, we have to walk together towards respect for life and sound sexual morality.”
Reprinted with permission from HLIWorldWatch.org
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