Introduction: Injectable somatostatin analogues (SRLs) are the standard medical management of acromegaly. Injection site adverse reactions reported for parenteral SRLs were examined in the literature and in the FDA Adverse Events Reporting System (AERS), and compared to the respective drug labels.
Methods: PubMed was searched using criteria: period 19952013, drugs octreotide (Sandostatin®), lanreotide (Somatuline®), or somatostatin analogues and adverse reactions of interest e.g. injection site reactions, in treatment of acromegaly and/or carcinoid tumours. FDA AERS files were reviewed for period Q1/2004 to Q1/2014. Adverse events reported in patients treated with somatostatin analogs were extracted as follows: i) drugs octreotide (Sandostatin®) and lanreotide (Somatuline®), ii) adverse events on which somatostatin analogs were the primary or secondary suspected drug, and iii) preferred terms (MedDRA) containing the keywords: Injection site, Application site and Administration site.
Results: Literature data showed injection site pain in up to 76%, with severe pain in 11%. Other adverse reactions included injection site erythema, hematoma, bruising, edema, induration, nodule formation, pruritus, and lipohypertrophy. In AERS the most frequent injection site adverse reactions reported were injection site mass (85 cases), haemorrhage (74), swelling (41), induration (29), discomfort, erythema, nodule (28 each), and haematoma (26). AERS cases increased annually from ten in 2004 to 434 in 2012 with a total of 858 AEs by case and 2389 AEs by individual report by Q1/2014.
Conclusion: The incidence of injection site adverse reactions in both the literature and the FDA AERS database is higher than that reported in respective somatostatin analog labels and includes AEs of significant concern. Because of the nature of reported injection site AEs and their potential physical burden to patients, an oral alternative to chronic parenteral injections would mitigate these parenteral adverse events and significantly benefit patient care.