(Reuters) – Newly unsealed court documents and other records show that Merck & Co and U.S. regulators knew about reports of suicidal behavior in men taking the company’s anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label.
Internal records from Merck were made public in late January, when a federal magistrate in Brooklyn, New York, granted a 2019 Reuters motion to unseal 11 documents filed in years of litigation alleging Propecia caused persistent sexual dysfunction and other harmful side effects.
Since the 2011 decision on the warning, the FDA has received more than 700 reports of suicide and suicidal thoughts among people taking Propecia or generic versions of the drug. Those included at least 100 deaths. Before that, in the first 14 years the drug was on the market, the agency received 34 such reports, including 10 deaths.
Annual U.S. prescriptions of finasteride, as the drug is known, for hair loss increased to over 2.4 million in 2020, more than double the number in 2015, according to health data company IQVIA.
European and Canadian regulators, citing similar reports among men taking finasteride, require a warning of suicidal thoughts on the label, though they note that research has not proved that the drug causes such thoughts. To this day, the U.S. label contains no mention of suicide or suicidal thoughts.
As early as 2009, Merck knew of more than 200 reports of depression, including suicidal thoughts, in men taking Propecia, according to an internal “risk management” assessment from that year. The company decided there were too few reports of serious depression and suicidal behavior and not enough specifics about those cases to warrant more than “routine” monitoring of safety data.
In 2011, two years after the Merck risk analysis, the FDA was weighing a company request to add “depression” to the drug’s label as a potential risk, with no warnings related to suicide. FDA analysts disagreed about adding a warning related to suicide, according to previously unreported government documents. But the regulator ultimately agreed with Merck’s request on the grounds that the number of suicides was lower than one would expect in this group of patients.
CALLS FOR TRANSPARENCY
Some medical researchers and patient advocates said Merck and the FDA have left American consumers in the dark about potentially life-threatening dangers associated with finasteride.
“No family should ever have to learn about this after the fact,” said Kim Witczak, a consumer advocate who serves on an FDA advisory panel for psychiatric drugs. She has called for drug companies and regulators to issue stronger warnings after her husband died from suicide in 2003 five weeks after being prescribed an antidepressant for insomnia. Merck “had an opportunity to put suicide on the label, but they didn’t want to do that because it’s all about sales.”
Michael Irwig, an endocrinologist and Harvard Medical School faculty member whose own research has found possible links between finasteride and suicidal behaviors, said Merck’s handling of the risk analysis and the FDA’s inaction keep critical information from the public. Merck “definitely should have provided a more complete picture,” Irwig said.
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. “Merck works continuously with regulators to ensure that potential safety signals are carefully analyzed and, if appropriate, included in the label for Propecia.”
Merck has said in past statements that Propecia has been prescribed safely to millions of men since the late 1990s. It also has 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.”
In a statement, FDA said it “continues to monitor postmarketing safety data for Propecia.” Overall, the agency noted that the presence of a report in the FDA database “does not mean the drug caused the adverse event” and medical problems may stem from the “underlying disease being treated, caused by some other drug being taken concurrently, or occurred for other reasons.”
FDA declined to comment further about its handling of Propecia and reports related to suicide.
