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Authorised allergen products for intracutaneous testing may no longer be
available in Germany: Allergy textbooks have to be re-written
#MMPMID26120551
Klimek L
; Werfel T
; Vogelberg C
; Jung K
Allergo J Int
2015[]; 24
(3
): 84-93
PMID26120551
show ga
BACKGROUND: Beside the skin prick test, the intracutaneous test represents the
most important skin test method for detecting type-1 allergies. With the
incorporation of European directives into national law, test allergens used for
allergy diagnosis are deemed medicinal products within the meaning of the German
Medicinal Products Act (Arzneimittelgesetz) and therefore require marketing
authorisation for distribution in Germany. The high costs of acquiring and
maintaining these authorisations have lead to no new finished intracutaneous test
products being authorized in Germany for more than 20 years. Instead, most
manufacturers have voluntarily withdrawn their existing marketing authorisations
for intracutaneous test extracts. The last manufacturer to offer approved
finished allergen products for intracutaneous tests recently announced that it
would now cease production and distribution of these solutions. METHODS: Research
on the current European and German legislation; selective literature search in
Medline, including national and international guidelines and Cochrane
meta-analyses; licensing information on the Paul-Ehrlich-Institute homepage
(www.pei.de) as well as in the Bundesanzeiger (Federal Gazette). RESULTS:
According to information on www.pei.de, marketing authorisations still existed as
of 31.01.2015 for intracutaneous test solutions of six grass/cereal/herbal
pollens, seven tree pollens, ten food allergens, twelve moulds and yeasts as well
as two fungal mixtures, five house dust and storage mites and five animal
epithelia/danders, all held by only one company in Germany. These marketing
authorisations were granted between 16th March 1987 and 17th January 1992; more
recent marketing authorisations do not exist. CONCLUSIONS: European legislation
and the associated increase in production and licensing costs have already lead
to numerous suppliers withdrawing their marketing authorisation for diagnostic
test allergens - marketing authorisations for 443 diagnostic allergens were
voluntarily withdrawn by manufacturers in 2013 alone. If the announced
restrictions on the allergen portfolio go ahead, considerable problems in the
management of allergy patients in Germany due to the discontinuation of the
intracutaneous test are likely to be encountered. Moreover, the fact that a
diagnostic procedure that has been established for decades seems set to disappear
quite simply because all the requisite substances vanish from the market in one
fell swoop may well be without parallel in modern medicine. The situation for
skin prick test allergens is less dramatic, although, here again, the available
range is becoming increasingly limited.
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