The Korea Food and Drug Administration said Thursday that all oral contraceptives will require a doctor’s prescription from as early as next year.

Currently the pills are sold over the counter except for Bayer’s Yasmin and Yaz. The change is expected to come into effect from as early as next year after the body finalizes its decision in July.

The “ground breaking” decision was made about 50 years after birth control pills were introduced to the country. KFDA officials said they have concluded the side effects of ethinyl estradiol, the main substance of such pills, are such that the pills should come under monitoring by doctors. 

“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,” Kim Sung-ho, a KFDA official, said.

According to the KFDA, side effects of oral contraceptives can include thrombosis, thromboembolism, thrombo puerperalis, myocardial infarction, cerebral hemorrhage and cerebral thrombosis among others.

The pills are banned from being administered to women with breast cancer, endometrial cancer, hepatitis and thromboembolism. Their use is also restricted among women who are over 40 years old, obese, have headaches, depression or other related conditions.

Oral contraceptives are designated as prescription drugs in the U.S., Japan, U.K., France, Germany, Italy, Switzerland and Canada.

Birth control pills, considered one of the most effective preventative methods against pregnancy, are not widely used in Korea. According to media reports, the oral contraceptive pill market is estimated to be worth about 20 billion won ($17.3 million) in sales a year, unusually small given the size of the country and population. According to the IMS report, only 2.5 percent of fertile women take the pills to avoid pregnancy.

“Somehow, the pills are not popular. The government’s decision will block more women from taking the pills. That’s not helpful in preventing unwanted pregnancies,” said Choi Anna, a gynecologist in Seoul.

The KFDA explained that birth control pills’ designation as OTC drugs has a political history.

“They were first adopted in the 1960s, when birth control was the utmost mission in the country. Therefore, side effects were undetermined and instead the drug was encouraged to curb the birthrate,” said a KFDA official.

Due to the family planning policies that remained throughout the 1990s, the efficacy and safety of the drugs has never been studied properly, she added.

“Currently oral contraceptives are used for not only prevention of conception but to control hormonal actions. We are not banning the purchase and use of drugs. We are asking for prudence. We are aware of the pros and cons and are willing to openly talk about it,” she said.

By Bae Ji-sook  (baejisook@heraldcorp.com)