MSD's hair loss treatment Propecia (Ingredient: finasteride) is causing controversy after a media report claimed that the company allegedly hid side effects of the drug in causing depression and, in some cases, suicides.

The controversy comes after Reuters recently reported that it had confirmed such facts by acquiring data related to the side effects of Propecia recently filed in the Brooklyn Federal Court in New York.

Despite Reuters' report, MSD Korea stressed that the product manuals for Propecia in Korea contain information on suicidal thoughts and depression. Reuters claims that the company tried to hide such cases is not true.

"Depression, suicidal thoughts, and psychological symptoms have been reported in Korean patients receiving 1 mg of Propecia," MSD Korea said. "In the event of a patient with a psychiatric symptom, the warning clause of the product permission clearly states patients to consult a medical professional after discontinuation of administration."

MSD Korea also refuted that Reuters' report that the FDA did not specify the suicidal thoughts warning.

Reuters reported that MSD had persuaded the U.S. Food and Drug Administration not to add information regarding suicidal thoughts to the warning box of Propecia.

Although the FDA received reports that more than 100 people made extreme choices after taking the Propecia and its generics in 2011, the agency accepted MSD's claim as the ratio of radical decisions was less than the natural rate.

"The method of presenting information differs depending on each country's decision," the company said. “Korea ordered Propecia and its generic drugs to add warning labels for depression and suicidal thoughts after MSD Korea reported adverse reactions that occurred overseas in 2017.”

The company further stressed that the causal relationship between Propecia and neuropsychiatric adverse reactions had not been established.

“However, the company is fulfilling its obligations to collect and report abnormal cases according to national regulations and accurately communicate potential safety issues through product manuals,” it said. “We monitor abnormal cases after marketing according to national regulations and report them to health authorities worldwide, such as the FDA.”

Korean physicians also warned against excessive interpretation and fear over the Propecia's side effects.

A doctor explained that the company had addressed the possibility of abnormal cases in the product label, and doctors prescribing the drug are fully aware of such adverse reactions.

"The company has already specified the possibility of depression and suicidal thoughts," Professor Huh Chang-hoon of the Department of Dermatology at Seoul National University Bundang Hospital said. "I can't agree that the company intentionally hid such information."

Huh also noted that the recent JAMA study on the risk of suicidal thoughts for patients taking finasteride had errors in its interpretation.

"This study has several errors," Huh said. "If finasteride induces suicide, the higher the concentration of the drug should show more side effects."

However, suicide rates only increased for a low dose 1 mg finasteride treatment, used for hair loss treatment, and there was no association of suicide in high dose 5 mg finasteride treatment used for benign prostatic hyperplasia, he added.

Huh stressed that it is common sense to believe that hair loss symptom caused extreme choices rather than drugs.

"Also, most medical staffs believe the study as unreliable because it is a regional study that did not include Asians and Africans," he said. "There are also many confounding variables such as age and other drugs are taken."

According to the documents obtained by Reuters, reports of adverse reactions to depression linked to Propecia were not small. Since 2009, MSD has received more than 200 reports of depression, including suicidal thoughts, in men taking Propecia.

However, MSD did not follow up on the reports. There were too few cases of serious depression and suicidal behavior, and there were no specific cases that required actions from the company besides monitoring for safety.