Longitudinal Patterns in Testosterone Prescribing After US FDA Safety Communication in 2014.

Area of Science:

• Endocrinology
• Health Services Research
• Pharmacovigilance

Background:

• A 2014 US Food and Drug Administration (FDA) safety communication prompted changes in testosterone prescribing patterns.
• Understanding these changes and their variation by physician characteristics is crucial for clinical practice and patient safety.

Purpose of the Study:

• To analyze shifts in testosterone prescription rates after the 2014 FDA safety communication.
• To investigate how these prescribing changes differed based on physician specialties and affiliations.

Main Methods:

• Utilized a 20% sample of Medicare fee-for-service administrative claims data (2011-2019).
• Included 1.5 million male beneficiaries and 58,000 physicians prescribing testosterone.
• Employed linear segmented models to assess prescription changes and their association with physician/organizational factors, considering coronary artery disease (CAD) and hypogonadism status.

Main Results:

• Following the FDA communication, off-label testosterone prescriptions decreased by 0.22 pp for patients with CAD and 0.16 pp for those without.
• Both on-label and off-label testosterone prescription trends showed initial declines, with off-label use increasing quarterly while on-label use decreased.
• Physician specialty (primary care) and affiliation with teaching hospitals correlated with larger decreases in off-label prescribing.

Conclusions:

• Testosterone therapy, both on-label and off-label, saw a reduction post-FDA safety communication.
• Physician characteristics influenced changes in off-label testosterone prescribing, but not on-label prescribing patterns.