Has vasculitis been reported in connection with Imedeen-treatment?/nA previous healthy 39-year-old

Fråga: Has vasculitis been reported in connection with Imedeen-treatment?

A previous healthy 39-year-old woman (smoker) has developed vasculitis in her fingers. There could be some time-relationship between the start of treatment with Imedeen and the onset of the vasculitis. The patient is at present treated with lanzoprazole (Lanzo), acetylsalicylic acid (Trombyl), iloprost (Ilomodin), Prednisolon, and glyceryl nitrate (Transiderm-Nitro). Treatment with these drugs started after the debut of the disease.

Sammanfattning: Imedeen is a food supplement consisting of proteins of marine origin, zinc gluconate, calcium gluconate, and ascorbic acid. None of these products has been reported to cause vasculitis.

Svar: Imedeen is sold as a food supplement for oral treatment of sun-damaged skin. The tablets contain proteins of marine origin, zinc gluconat, calcium gluconate, and ascorbic acid. The producer (Ferrosan AB) describes the marine proteins as "special proteins and glucosaminoglycans extracted from a fish living in deep, cold water" (1, 2). The package states that since Imedeen contains marine proteins it may, like other seafood and marine products, cause allergic reactions in some people.

A thorough literature search in databases including Drugline, Medline and Embase could not find any information about vasculitis as an adverse effect of Imedeen.

The efficacy and safety of Imedeen on photoaged skin have been examined in a three-month placebo-controlled randomised study of 144 subjects and a nine-month open uncontrolled prospective continuation (3). No significant effects of Imedeen compared with placebo could be detected after 3-month treatment, but one-year treatment gave an improvement of the skin condition compared with baseline in investigator´s assessment and volunteers´ self-evaluation. Safety assessment consisted of routine blood chemistry and questioning of the subjects. No serious side-effects related to treatment were reported. Mild or moderate acne, seborrhoea, oedema, and weight increase were the most frequently reported adverse events during the study (3).

No reports on vasculitis as an adverse effect of the patient´s other drugs were found. 1 Summary product characteristics Imedeen (Ferrosan AB) 2 Personal communication: Sofie von Homeyer (Ferrosan AB) 3 Kieffer ME, Efsen J: Imedeen in the treatment of photoaged skin: an efficacy and safety trial over 12 months. J Eur Acad Dermotal Venereol 1998; 11: 129-136