(Health Korea News / Yoo Ji-in) As hair loss treatments ‘Finasteride’ and ‘Dutasteride’, which are widely used in Korea, are embroiled in controversy over causing suicidal thoughts, attention is focused on whether these drugs will be withdrawn. Korea’s Ministry of Food and Drug Safety also immediately began a safety review.
Major foreign media outlets, including Reuters, reported that the European Medicines Agency’s (EMA) Safety Control Committee (PRAC) has begun reviewing the alopecia treatments ‘Finasteride’ and ‘Dutasteride’, which have raised safety concerns such as suicidal impulses and execution.
After reviewing the results of PRAC’s deliberation, EMA plans to recommend whether to withdraw, suspend, or maintain the marketing authorization for the drug.
The drugs subject to review are Propecia (finasteride) from MSD in the U.S. and Avodart (dutasteride) from GSK in the U.K. For reference, both drugs are also used to treat benign prostatic hyperplasia (BPH).
‘Finasteride’ and ‘Dutasteride’ are representative drugs that dominate the global hair loss treatment market, and have not been free from psychiatric side effects (adverse reactions) issues.
On the 4th, the French regulatory agency, the National Agency for the Safety of Medicines and Health Products (ANSM), said, “We have reviewed all clinical data on suicidal ideation and suicide related to medicines containing these two ingredients to ensure that these potential risks are not reflected in the benefit-risk balance of the products.” “We need to review the impact,” he said.
ANSM said, “Although a causal relationship between finasteride and suicidal thoughts has not been clearly proven, it is considered at least a reasonable possibility considering that known adverse drug reactions such as sexual dysfunction, erectile dysfunction, depression, and decreased libido can cause suicidal thoughts.” “It is possible,” he said, raising the need for a safety review.
This is not the first time issues have been raised about the ingredients of the two drugs. A patient group called the Finasteride Syndrome Foundation called on regulators in 2017 to stop selling the drug.
As the controversy continued, the European Union (EU) added the phrase ‘side effects of unknown frequency’ related to suicidal thoughts to the ‘Finasteride’ product information, and the US Food and Drug Administration (FDA) added suicidal thoughts and behavior to the product label. A warning was displayed for .
The two controversial ingredients are currently produced and sold in numerous generic versions in Korea. There are 216 types of generic drugs for finasteride and 114 types of generic drugs for dutasteride that have received product approval from the Ministry of Food and Drug Safety.
Korea’s Ministry of Food and Drug Safety has also begun a safety review. An official from the Ministry of Food and Drug Safety said, “As the European regulatory authorities have begun a review, the Ministry of Food and Drug Safety is aware of this,” and added, “We plan to continuously monitor and look into the matter.”
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