[Post-marketing safety profile of avocado-soybean unsaponifiables].

OBJECTIVE

To determine the post-marketing safety profile of avocado-soybean unsaponifiables since their commercialization in France until 2008.

METHODS

We used data provided by French spontaneous reporting system via the network of National Pharmacovigilance centres. We analysed all suspected adverse drug reactions (ADRs) concerning avocado-soybean unsaponifiables (ASU) reported between 1978 and 2008 and notified in the French Pharmacovigilance Database.

RESULTS

We kept 117 ADRs concerning 117 patients (mean age 65.5 years, 72% female). ADRs (35.9%) were "serious" (resulted in hospitalisation or prolonged it). No death was reported. In most of cases, causality of ASU was "possible" and others drugs were also suspected. The most frequently reported ADRs were cutaneous (32.5% of all ADRs, with eczemas or urticaria), hepatic (16.2%, mostly hepatocellular injuries) and gastrointestinal (12%, with 9 cases of colitis and/or diarrhea) ADRs. In these cases, dechallenge of ASU allowed rapid regression of symptoms. Others significant ADRs were coagulation and platelet (6.8%), neurological (6%) and metabolic or nutritional (4.3%) disorders.

CONCLUSIONS

This Pharmacovigilance analysis of ASU notified since their commercialisation in France highlights the diversity of ADRs with several class-organ involved. Cutaneous, hepatic and gastro-intestinal disorders were the most frequently reported ADRs. Since ASU is largely prescribed in France, incidence of their ADRs seems to be "very rare" (although we did not take into account the part of under-notification). These safety data should be discussed in the light of the poor expected clinical benefit of ASU in rheumatology (low "Service Medical Rendu") or in stomatology (insufficient "Service Medical Rendu").