Separately, safety signal of causal link between finasteride and diabetes mellitus issued by Saudi FDA in 2021
March 2, 2022
In a confidential 2018 letter to health care professionals, Merck & Co.’s Saudi Arabian subsidiary warned that finasteride patients should be carefully monitored for psychiatric symptoms including anxiety, depression and suicidal ideation.
Furthermore, the dispatch reads, “If a patient treated with 1 mg finasteride develops psychiatric symptoms, treatment should be stopped and the patient advised to seek medical advice. If a patient treated with 5 mg finasteride develops psychiatric symptoms, the patient should be advised to seek medical advice.”
Known as a Direct Healthcare Professional Communication (DHPC), and issued by Abdulilah Al Malik, Regulatory Affairs Director, Saudi Arabia, Merck Sharp & Dohme Scientific Office (below), the warning is titled “Possible risks of sexual dysfunction and psychiatric disorders with medicinal products containing finasteride (1 mg and 5 mg dosage) and recommendations for informing patients.”
The DHPC was turned up last week on the website of the Saudi Food & Drug Authority (SFDA) during the PFS Foundation’s annual audit of federal drug-regulatory agencies worldwide. It could not be found, however, on the MSD Saudi Arabia website, nor on the website of Organon, the Merck spinoff that last year acquired finasteride products Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg).
The document also noted that “Patients should be aware of the risk of experiencing the adverse event (AE) of sexual dysfunction (including erectile dysfunction, ejaculation disorder, and decreased libido) during finasteride therapy. Patients should also be informed that case reports have been received of sexual dysfunction AEs that persisted after discontinuation of therapy.”
“This letter essentially amounts to what the US Food and Drug Administration calls a ‘black box warning,’ alerting not only health care providers but the general public that finasteride could cause serious injury or lead to death,” says PFS Foundation CEO John Santmann, MD.
“But that presents the question, Why did Merck mark the warning, which clearly has global public-health implications, as confidential? If the warning was serious enough to alert the people of Saudi Arabia, why not the people of Israel or South Africa or Japan or Argentina or any nation, for that matter?” Dr. Santmann continues.
“Since our founding in 2012, we’ve been contacted by more than 3,000 PFS patients from every continent except Antarctica. Within that sample are both men and women, from all sexual identities, ranging in age from 15 to 85, which leads us to believe that any human being on earth is potentially susceptible to PFS.”
Separately, in 2021, the National Pharmacovigilance Center of the SFDA assessed the causality between finasteride and the risk of developing diabetes mellitus. That, by examining its own data in tandem with data from the World Health Organization’s VigiBase.
The results revealed a positive statistical association for the drug/ADR combination, meaning diabetes mellitus with the use of finasteride has been observed more than expected compared to other medications available in the WHO database.
In a safety signal released in August, the agency concluded: “The weighted cumulative evidence…are sufficient to support a causal association between finasteride and the risk of diabetes mellitus. Health regulators and health care professionals must be aware of this potential risk.”
Anyone living in the US who suffers from PFS should report his symptoms to the US Food and Drug Administration. Anyone living outside the US who suffers from PFS should report his/her symptoms to the US Food and Drug Administration and to his/her national drug-regulatory agency, as directed on our Report Your Side Effects page.
Finally, if you or a loved one are suffering from PFS, and feeling depressed or unstable, please don’t hesitate to contact the PFS Foundation as soon as possible via our Patient Support hotline: firstname.lastname@example.org