Gynecomastia Possibly Induced by Rosuvastatin

Abstract

Gynecomastia is characterized by benign progressive enlargement of the male breast. A pharmacologic origin is identified in 10-20% of cases. Several case reports have associated this condition to the use of statins. However, to our knowledge, no case of rosuvastatin-induced gynecomastia has been reported in the literature. We describe a 57-year-old man who developed bilateral gynecomastia after 2 months of rosuvastatin therapy. After switching to a different statin, atorvastatin, his symptoms resolved within 1 month. Use of the Naranjo adverse drug reaction probability scale indicated a possible relationship between the patient's development of gynecomastia and rosuvastatin therapy. The relatively strong effect of rosuvastatin on inhibiting steroidogenesis might have explained why our patient's gynecomastia occurred only with this agent. Clinicians should be aware of the possibility of adverse endocrine reactions when statins are prescribed, including newer agents such as rosuvastatin.

Statin-associated gynecomastia: evidence coming from the Italian spontaneous ADR reporting database and literature

“…The information provided by the published case-reports [7][8][9][10] was consistent with that retrieved from the Italian spontaneous reporting system, including data on age, exposure period to the suspected drug before the onset of gynecomastia and positive response to dechallenge. In agreement with the predisposing factors suggested in the case-reports mentioned above, in our analysis we found (1) six cases in which the starting-doses reported were higher than those suggested in the labels (cases no.…”

“…Positive dechallenge was reported in eight of the nine cases (see Table 2). [9], rosuvastatin 20 mg/day [10] and rosuvastatin 5 mg/day [7]. The age of the patient ranged from 46 to 72 years, and the time of gynecomastia onset varied between 2 and 6 months from the first statin use.…”

“…In all cases, patients responded positively to dechallenge or to a therapeutic switch to a less potent statin. The authors of these case-reports suggested a number of possible predisposing factors for the onset of statin-induced gynecomastia, including a too high starting dose [10], a dosage augmentation that was not tolerated and/or a therapeutic switch to a more potent active ingredient [9].…”

“…Although a number of cases of statin-induced gynecomastia have been reported during post-marketing surveillance [7] and four case-reports have been published [7][8][9][10], statins are not commonly included in the list of medications associated with gynecomastia [3,4], and the Summary of Product Characteristics (SPC) of several statins are still do not mention this concern [11][12][13][14].…”

A generalised sensation of coldness following introduction of rosuvastatin therapy

“…Other adverse effects have been reported in the context of case-report studies, such as pemphigoid,7 erythema multiforme,8 erythromelalgia,9 recurrent pancreatitis,10 11 thrombocytopaenia,12 gynaecomastia,13 as well as short-term memory loss 14. These unusual adverse effects are currently anecdotal and occurred with doses of rosuvastatin between 5 and 40 mg daily.…”