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New finasteride lawsuit brings renewed attention to psychiatric, ED adverse event reports


A new lawsuit seeking to force the Food and Drug Administration to act on a request to add stricter warnings to finasteride or remove it from the market may rekindle a debate on whether some of the observed side effects from the hair loss drug merit a closer look and, potentially, better counseling and monitoring from clinicians.

Dr. Robert M. Bernstein

Dr. Robert M. Bernstein

The nonprofit advocacy group Public Citizen filed the suit on behalf of the Post-Finasteride Syndrome Foundation (PFSF) in the U.S. District Court for the District of Columbia. The PFSF had filed a citizen’s petition in 2017 that requested that the FDA either take the 1-mg formulation off the market, or add warnings about the potential for erectile dysfunction, depression, and suicidal ideation, among other adverse reactions.

The PFSF has alleged that long-term use of Propecia (and its generic equivalents) can lead to postfinasteride syndrome (PFS), characterized by sexual dysfunction and psycho-neurocognitive symptoms. The symptoms may continue long after men stop taking the drug, according to PFSF.

Public Citizen said the FDA needs to take action in part because U.S. prescriptions of the hair loss formulation “more than doubled from 2015 to 2020,” and online and telemedicine companies such as Hims, Roman, and Keeps “aggressively market and sell generic finasteride for hair loss.” According to GoodRx, a 1-month supply of generic 1-mg tablets costs as little as $8-$10.

Both Canadian and British regulatory authorities have added warnings about depression and suicide to the Propecia label but the FDA has not changed its labeling. An agency spokesperson told this news organization that the “FDA does not comment on the status of pending citizen petitions or on pending litigation.”

Propecia’s developer, Merck, has not responded to several requests for comment from this news organization.

Why some patients develop PFS and others do not is still not understood, but some clinicians said they counsel all patients on the risks of severe and persistent side effects that have been associated with Propecia.

Robert M. Bernstein, MD, of the department of dermatology at Columbia University, New York, and a fellow of the International Society of Hair Restoration Surgery, said that 2%-4% of his patients have some side effects, similar to the original reported incidence, with sexual dysfunction being the most common.

If a man experiences an adverse effect, the drug should be stopped, Dr. Bernstein said in an interview. He noted that “there seems to be a significant increased risk of persistent side effects in people with certain psychiatric conditions, and those people should be counseled carefully before considering the medication.”

“Everybody should be warned that the risk of persistent side effects is real but in the average person it is quite uncommon,” added Dr. Bernstein, founder of Bernstein Medical, a division of Schweiger Dermatology Group focusing on the diagnosis and treatment of hair loss. “I don’t think it should be withdrawn from the market,” he said.

Dr. Alan R. Jacobs

Dr. Alan R. Jacobs

Alan Jacobs, MD, a Manhattan-based neuroendocrinologist and behavioral neurologist in private practice who said he has treated hundreds of men for PFS, and who is an expert witness for the plaintiff in a suit alleging that finasteride led to a man’s suicide, said that taking the drug off the market would be unfortunate because it helps so many men. “I don’t think you need to get rid of the drug per se,” he said in an interview. “But very rapidly, people need to do clinical research to find out how to predict who’s more at risk,” he added.

Michael S. Irwig, MD, associate professor of medicine at Harvard Medical School, Boston, who has studied the persistent sexual and nonsexual side effects of finasteride, said he believes there should be a boxed warning on the finasteride label to let the men who take it “know that they can have permanent persistent sexual dysfunction, and/or depression and suicide have been noted with this medicine.

“Those who prescribe it should be having a conversation with patients about the potential risks and benefits so that everybody knows about the potential before they get on the medicine,” said Dr. Irwig, who also is an endocrinologist at Beth Israel Deaconess Medical Center in Boston.


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