Sevista (Ormeloxifene) for Mastalgia
Ormeloxifene (Sevista) appears to be the most effective pharmacological treatment for mastalgia with the least side effects, though it is not currently FDA-approved or licensed in many developed countries including the UK and US. 1
Evidence for Ormeloxifene in Mastalgia
Ormeloxifene demonstrates the greatest benefit with the least side effects among pharmacological agents for mastalgia treatment. 1
This selective estrogen receptor modulator (SERM) is currently being used for mastalgia management in India with encouraging results. 1
Ormeloxifene shows superior tolerability compared to traditional hormonal treatments like danazol, tamoxifen, and bromocriptine, which are limited by androgenic or menopausal side effects. 1
Treatment Algorithm for Mastalgia
First-Line Management (Should Always Be Attempted First)
Reassurance that breast pain alone rarely indicates cancer resolves symptoms in 86% of mild cases and 52% of severe cases. 2
Proper bra fitting and supportive bras, especially during exercise, should be recommended. 2
Over-the-counter NSAIDs (topical or oral) provide relief in 70-92% of women when combined with reassurance. 1, 2
Second-Line Management (If First-Line Fails)
Topical NSAIDs are preferred over systemic options due to fewer side effects. 1
Dietary modifications including reducing coffee and fat intake may provide some benefit, though evidence for caffeine reduction is not convincing. 2, 1
Third-Line Pharmacological Options (For Severe, Refractory Cases)
If ormeloxifene is available in your region:
- Ormeloxifene should be considered the preferred SERM for persistent mastalgia due to its favorable side effect profile. 1
If ormeloxifene is not available:
- Danazol (the only FDA-approved hormonal treatment) maintains high response rates even after failure of other drugs, with 75% of surgeons using it as their primary hormonal agent. 3, 4
- Danazol is best used in cyclic form to limit adverse effects (androgenic side effects, weight gain). 5, 6
- Tamoxifen and bromocriptine are alternatives but have significant side effects. 6, 1
Critical Considerations
Only 15% of women with mastalgia require pharmacological therapy beyond reassurance and simple measures. 5, 6
Cyclical mastalgia responds better to treatment (92% response rate) compared to noncyclical mastalgia (64% response rate). 6
Noncyclical mastalgia responds poorly to hormonal manipulation and resolves spontaneously in up to 50% of cases. 7, 5
Approximately 60% of cyclical mastalgia recurs after treatment cessation. 5
Important Pitfalls to Avoid
Do not dismiss breast pain without proper evaluation, as invasive lobular carcinoma and anaplastic carcinoma are disproportionately associated with mastalgia. 7, 2
Do not prescribe hormonal treatments without first attempting reassurance, proper bra fitting, and NSAIDs. 1
Avoid using hormonal agents as first-line therapy due to significant side effects including gynecomastia, mastalgia (ironically), hyposexuality, and erectile dysfunction in male partners taking spironolactone. 7
Do not continue ineffective treatments beyond 3 months without reassessing the diagnosis. 8