Group sues to have hair-loss drug Propecia pulled from market

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The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. REUTERS/Brendan McDermid

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  • More than 2.4 million prescriptions written in 2020
  • Cites Reuters report that Merck and FDA knew of suicidal thoughts in Propecia patients in 2011

(Reuters) - A patient advocacy group has filed a lawsuit seeking to pull Merck & Co's hair loss drug Propecia and its generic versions from the market, saying federal regulators had failed to act on evidence that it causes depression, erectile dysfunction and, in some cases, suicide.

In a lawsuit filed Wednesday in Washington, D.C., federal court, the Post-Finasteride Syndrome Foundation, represented by Public Citizen, said the Food and Drug Administration had unlawfully failed to either grant or deny a citizen petition the group submitted in 2017. Finasteride is the active ingredient in Propecia.

The FDA and Merck did not immediately respond to requests for comment.

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Anti-baldness treatment Propecia was approved in 1997, and the first generic version was approved in 2006. In 2012, Merck added a warning that the drug could cause sexual dysfunction and depression, prompting a wave of patient lawsuits.

Nonetheless, the drug's popularity continued to grow. Annual U.S. prescriptions of finasteride increased to over 2.4 million in 2020, more than double the number in 2015, according to health data company IQVIA.

The Post-Finasteride Syndrome Foundation was founded in 2012 to support research into post-finasteride syndrome, a term use by some researchers to describe persistent side effects of the drug.

In 2017, the group petitioner the FDA to either pull the drug from the market or add a "black box" warning – used for the most severe side effects – that the drug could lead to suicidal thoughts.

In Wednesday's lawsuit, the foundation said the agency had unlawfully failed to act despite "ample evidence" that the drug was associated with a higher risk of suicide.

It cited a recent Reuters report, based on newly unsealed court documents, that Merck and the FDA knew of reports of suicidal thoughts in Propecia patients in 2011, when the agency was considering the added warning that ultimately made no mention of suicide. At the time of the report, 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.

The foundation also noted that Canadian and European regulators do require a warning about suicide, and advise that treatment be discontinued if a patient becomes depressed.

"FDA's decisional process is lagging unreasonably in light of the nature and extent of the public health interests addressed in the petition and its supplements," the complaint said.

The case is Post-Finasteride Syndrome Foundation v. Food and Drug Administration, U.S. District Court, District of Columbia, No. 1:21-cv-02374.

For plaintiff: Michael Kirkpatrick and Adina Rosenbaum of Public Citizen Litigation Group

For FDA: Not available

Read more:

Merck anti-baldness drug Propecia has long trail of suicide reports, records show

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Brendan Pierson reports on product liability litigation and on all areas of health care law. He can be reached at brendan.pierson@thomsonreuters.com.