Adverse effects of cosmetics and toiletries reported to the Swedish Medical Products Agency 1989-1994.
In Sweden, a cosmetic control system was introduced in 1989 at the Medical Products Agency (MPA). It consists of a register of importers, manufacturers and their products, and a voluntary adverse reaction reporting system identical to that concerning drugs. Between 1989 and 1994, MPA evaluated 191 reports concerning adverse effects of 253 cosmetics and toiletries. 90% of the reports concerned women and the top-ranking product category was moisturizers, followed by hair care products and nail products. The majority of the adverse effects reported involved only the skin, and 90% were eczematous reactions. 70% of the eczemas were classified as contact allergic, as patch tests were positive to the product as is, and in 1/2 of these products, 1 or more relevant allergens could be identified when tests were made with individual cosmetic ingredients. The most common offending ingredients were fragrances, toluenesulfonamide-formaldehyde resin and preservatives. The number of reports is small in relation to the expected number of cosmetic adverse effects, which can be explained by under-reporting. Efforts are being made to persuade Swedish physicians to report more often.
Berne
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Medical Products Agency, Uppsala, Sweden.
Boström
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Grahnén
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Tammela
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D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D003358:Cosmetics / Q000009:adverse effects*; D017449:Dermatitis, Allergic Contact / Q000209:etiology; D003877:Dermatitis, Contact / Q000209:etiology*; D017453:Dermatitis, Irritant / Q000209:etiology; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D012042:Registries; D013548:Sweden
D003358:Cosmetics