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Watchdog suspends sales of anti-diarrheal medications

South Korea‘s drug watchdog said Thursday that it has temporarily suspended sales of several dozen anti-diarrheal medications, the first such move in more than two decades.

The move by the Ministry of Food and Drug Safety comes as Dongwha Pharm Co., one of major South Korean drugmakers, was found to have used a combination of two different strains of lactobacillus in making Lacteol than the one that was originally approved by the government in 1988.

Lacteol is a brand name of lactobacillus acidophilus, one of friendly bacteria that is naturally found in the body and is used to treat diarrhea. Lactobacillus acidophilus, a Latin word for acid-loving milk-bacterium, is also used in yogurt and milk as well as dietary supplements.

The drug watchdog said lactobacillus acidophilus has not been fully verified by the government for its efficacy in treating acute diarrhea, though it does not pose any health threat.

“No side effects of the drugs have been reported,” said Kim Seong-ho, director for pharmaceutical policy division at the ministry, adding that the move is a precautionary step.

Dongwha Pharm said it has been making capsules, tablets and granules of Lacteol since 1988 when it signed a licensing deal with Aptalis. S.A., a French pharmaceutical company that develops Lacteol.

A total of 44 other South Korean drugmakers were producing 56 generic versions of Lacteol.

Dongwha Pharm also said Lacteol is also available in some 50 countries, though it did not say whether Aptalis exports the drug or inks similar licensing deals with other drugmakers in those countries. (Yonhap News)
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