世界卫生组织称非那雄胺不良反应周环比飙升10,000%

令人震惊的是,自杀意念数量比 2024 年的记录高出 42%(距 2025 年还有 6 个月),其中包括 119 份新的自杀意念报告

2025年5月17日

亲爱的朋友们:

以这样的速度,“崩溃”可能意味着一场流行病灾难。

Week over week, the all-time number of adverse drug reactions (ADRs) for finasteride rose from 22,297 to 25,329, or 13%, including two new suicides, and 119 new reports of suicidal ideation.

That, according to the World Health Organization’s VigiBase database of ADRs, officials at which confirmed the statistics directly to the PFS Foundation

Alarming Analysis

To give you some idea of what a 13% upswing in a single week means in the context of reporting that stretches back 32 years, consider this:

For the first 17 weeks of 2025, the average rise in new finasteride ADRs reported to the WHO was 29.5, ranging from a low of five per week to a high of 42. But for the week ending May 11, the number of new ADRs clocked in at 3,032.

That’s a 10,178% rise over the year-to-date weekly average.

The WHO has been aggregating finasteride ADRs from its 194 member states since 1993, when the drug was granted market authorization by the US Food and Drug Administration (FDA). In 2024, they shot to a record 2,127, representing a 181% rise over 2023.

If we run the same calculation for 2025, we get a 42% rise over last year’s record. However, there are still 34 weeks to go in the year. If such growth continues through December, it could signal a full-blown PFS epidemic.

Now consider one more thing: On Jan. 1 of this year, total finasteride ADRs stood at 21,794. Today, they stand at 25,329, which means a year-to-date total of 3,535 new ADRs. Divide that by the 128 days that have passed between Jan. 1 and May 9 (the most recent day of reporting to the WHO) and we get an average of more than 27 ADRs per day.

Or, more than one new ADR every hour of every day thus far in 2025.

25,000-foot view

Over the past decade, total finasteride ADRs have risen 101%, from 12,586 to 25,329, while suicidal ideation—which the European Medicinces Agency (EMA) last week confirmed as an official side effect of the drug—has spiked 321%, from 171 to 720.

For the same period, suicide attempt has climbed 107%, from 27 to 56, and completed suicide has escalated 182%, from 40 to 113.

While the WHO declined to offer any interpretation of this data, it would seem reasonable to believe it’s related to recent actions by drug-regulatory authorities including the FDA, MHRA and EMA, along with media coverage of PFS in the US, UK, Canada, Spain, Russia and elsewhere.

“Beginning this week, we’re advising all drug-regulatory authorities outside the US to watch the VigiBase data on finasteride ADRs very closely, and act accordingly in terms of doing no harm to their citizens,” said PFS Foundation President Philip Recchia.

“Don’t depend on new guidance from the FDA, which may not arrive until years from now—if ever.”

The gains in Spain

On Monday, El Confidencial, Spain’s largest online newspaper—which broke the story of PFS patient Carlos Sarasa González-Aller’s death leap from atop his office building—published an interview with Recchia (The Man Who Has Spent 25 Years Studying Finasteride) (English).

In it, reporter Alfredo Pascual references the EMA’s recent findings regarding a causal relationship between finaseride use and suicidality. “The study is a vindication for Recchia and the PFS Foundation, who have long been accused of spreading alarm and fueling the nocebo effect,” he writes, before thusly quoting Recchia:

“You have no idea what it’s been like these past few years, with so many so-called ‘respectable’ doctors telling us PFS was all in the patients’ heads. That’s like telling Dachau prisoners that the guards marching toward their barracks are just the boogeyman.

“From what we know, the potential dangers of finasteride far outweigh its benefits. In that light, it would make sense for health authorities to suspend its use until we have a better understanding of the risks.”

A day later, ABC, another national Spanish newspaper, ran a story headlined, Mother of a finasteride victim: “If the drug were banned, my son would still be alive” (English).

“A day before the EMA confirmed a link between the drug finasteride…and suicidal thoughts, Juana A. stepped forward to explain to ABC the most painful experience of her life: the death of her son Pedro (fictitious name) on which, she blames the use of this controversial drug,” writes Esther Armora.

“‘I’ve decided to make it public, even if it hurts me to remember, to prevent other parents from going through what we’re going through,’ says the mother. She sums up the new EMA warning as a positive step, but calls for more drastic measures to prevent the drug from continuing to take lives.”

Finasteride最初由默克公司(Merck & Co., Inc.)开发,并于1993 年首次获得美国食品药品监督管理局批准,作为保列治(5毫克,用于治疗前列腺增生),并于1997年再度获得批准,作为保法止(1毫克,用于脱发)。

2021年6月,默克将其子公司Organon剥离为一家独立的上市公司(NYSE:OGN)。Organon 成立于1923年的荷兰,致力于为女性、她们的家庭和她们所关心的社区带来世界级的医疗服务。

在交易中,Organon获得了默克的保列治和保法止等产品。如需报告任何菲娜雄安产品的副作用,请拨打Organon服务中心电话(844)674-3200,或发送电子邮件至Service_Center@Organon.com

在美国的PFS患者应向美国FDA报告其症状。在美国以外的PFS患者应向美国FDA及其当地药品监管机构报告症状,具体信息请访问描述对你的副作用页面。

如果您或您的亲人正在遭受PFS,并感到抑郁或不稳定,请立即通过我们的患者支持热线联系PFS基金会social@pfsfoundation.org

谢谢。