Abstract
Objective
To quantify reports made to the Food and Drug Administration Adverse Event Reporting
System (FAERS), create a demographic of patient reports, and examine the cluster of
symptoms to correlate consistency of postfinasteride syndrome (PFS) complaints. PFS
is a provisional diagnosis encompassing a cluster of sexual, physical, and psychological
and/or neurologic symptoms associated with 5-alpha reductase inhibitor use that emerge
or continue after discontinuation of medication.
Materials and Methods
FAERS dataset of 5-alpha reductase inhibitors from April 2011 to October 2014 was
obtained. Each FAERS report had 16 categories for completion, but not every report
was fully completed. Statistical analysis compared variables of interest between the
2 doses of finasteride (1 mg vs 5 mg).
Results
From FAERS, 2048 monotherapy cases were identified: 1581 of finasteride 1 mg, 240
of finasteride 5 mg, and 226 of unreported doses. Possibly related to labeling changes,
from 2011 to 2014, there was a significant increase in adverse events (AEs) reported
involving 1 mg dosing. Finasteride use was reported with many sexual AEs including
diminished libido, erectile dysfunction, and ejaculatory complaints. Other common
AEs included dermatologic, metabolic, and psychological and/or neurologic complaints.
There were more AE reports with the 1 mg dose than the 5 mg dose. One case of dutasteride
reported back pain, not generally attributed to PFS.
Conclusion
FAERS data suggests that finasteride exposure is reported with a diverse collection
of symptoms, particularly in younger men on 1 mg dosage compared to older men on 5
mg. Many of these complaints fall well out of the realm of previously established
AEs from long-term controlled studies.
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Article Info
Publication History
Published online: June 27, 2018
Accepted:
June 14,
2018
Received in revised form:
May 31,
2018
Received:
September 20,
2017
Footnotes
Conflict of Interest: KTM: Retained as expert in litigation involving finasteride by Merck Inc. No other conflicts noted for other authors.
Identification
Copyright
© 2018 Elsevier Inc. All rights reserved.
