The Ministry of Food and Drug Safety announced plans Tuesday to revise warning labels of 142 items, which include Finasteride, commonly used in treatment for male hair loss to indicate depressive and suicidal thoughts.
Finasteride, often sold under the brand names Proscar and Propecia, is used to treat benign prostatic hyperplasia and male pattern hair loss.
|Ministry of Food and Drug Safety|
Merck & Co’s Propecia is the world’s first male hair loss drug to gain the U.S. Food and Administration’s approval in 1997. In April 2016, the FDA announced revisions to the warning label to add adverse effects for libido, ejaculation, and orgasm disorders after discontinuation. The drug also hit the spotlight in February 2017 when the New York Times reported that President Donald Trump was an avid user.
The recent revision comes after MSD Korea, the Korean offshoot of Merck & Co, reported adverse effects of its parent company’s drug to the ministry. The changes to the warning label will affect 142 items from 98 corporate entities.
Propecia has sustained its position as the market leader since it gained the ministry’s approval in 2000 even though numerous copies were released after its patent expired in 2008.
JW Shinyak’s Monad and Hanmi Pharmaceuticals' Finated are the leading generics next to Propecia, with JW Shinyaks’ Monad grossing the second highest sales with 6.6 billion won ($5.8 million).
“We will change the warning label by examining the safety report. In the meantime, we will proceed to collect opinions from related organizations until Friday, according to the legal procedure,” a ministry official said.
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