Merck & Co reportedly knew about reports of suicidal tendencies in men who were taking their anti-baldness treatment Propecia but the company decided not to warn consumers about the potential risks, newly unsealed court documents reveal. According to a Reuters report, US regulators also knew about the potential risks in a 2011 update of the label of Propecia.
According to the report, the FDA has received more than 700 reports of suicide or suicidal thoughts among men who consumed Propecia since the 2011 decision. However, the origin of the problem with the drug started from the time it was introduced in the markets.
Concealing Vital Information
Internal records from Merck were made public in January following permission from a federal magistrate in Brooklyn, New York, for a 2019 Reuters motion to unseal 11 documents related to litigation against the drug that resulted in sexual dysfunction and other side effects including suicidal thoughts.
The newly unsealed documents reveal that the FDA received at least reports of 100 deaths after using Propecia or generic version of the drug. However, by that time it was already in the market for 14 years. During the first 14 years, the FDA received 34 such reports including 10 deaths.
The documents also reveal that by 2009 Merck knew of 200 such reports including suicidal thoughts and depression in men consuming the drug. However, the pharma giant felt that the reports of suicidal tendencies and depression were too negligible and the monitoring of safety data wasn't required.
Still No Warning
Propecia, also known as finasteride, over the years has gained immensely popularity, with annual prescriptions of the drug growing to over 2.4 million in 2020, more than double the number five years back. However, till date the US label doesn't contain any warning of suicide or suicidal tendencies. The European and Canadian regulators although require a warning of suicidal thoughts on the label after having received similar reports.
In 2011, two years after a risk analysis by Merck, the FDA was contemplating a request from the company to add "depression" to the label as a potential risk. However, it didn't think of issuing warnings related to suicide despite receiving reports. According to the Reuters report, experts and medical researchers claim that both Merck and the agency despite knowing the dangerous side effects of the drug kept consumers in the dark by not issuing warning on suicide or suicidal thoughts on the drug's label.
However, Merck still continues to defend itself and doesn't see any requirement for such a warning. In a statement to Reuters, Merck said that "the scientific evidence does not support a causal link between Propecia and suicide or suicidal ideation and these terms should not be included in the labeling" for the drug.
FDA in a statement said that it "continues to monitor postmarketing safety data for Propecia." FDA had earlier argued in court that "premature hair loss itself, the very condition for which Propecia is prescribed, is associated with low self-esteem, poor body image, and depression."