We inform all members that the Ministry of Health, granting our request about “Medicines and Celiac Disease”, has confirmed the implementation of the relevant European Regulations. To that end, we attach the following official announcements from the Ministry:
enclosure 1 letter from the Ministry to the following Institutions: FARMINDUSTRIA, ANIFA, ASSOGENERICI and FEDERFARMA and in copy to AIC
enclosure 2 explanatory document from the Ministry of Health
The document asserts and confirms that the limits currently imposed by Farmacopea Europea (respect for which is verified by Office IV-Ministry of Health) means we can also consider medicines containing wheat starch (*) as being suitable for subjects with celiac disease.
In any case, this information must always be reported on the labeling so as to provide proper information.
These considerations, however, do not apply to people who are “allergic” to wheat starch.
Considering the foregoing, tables (1-6) below report the calculation of the quantity of gliadin contained in a hypothetical tablet weighing from 0.1 to 1g.
Remember that there is no danger for the celiac (intolerant to gluten) when the medicine contains any of the following as excipients: pregelatinized starch, carboxymethyl starch, sodium starch glycolate or wheat starch.
Moreover, this directive refers to medicines (specialty and generic) and not to paramedicines (e.g. pharmaceutical or food supplements, etc.) or homeopathic preparations, or products sold in herbalist shops, which therefore are not included in the considerations made previously.
The opinion expressed by the National Scientific Committee during the meeting of 6 February is reported in the last file (n° 7) below.
Thanks to the provisions of Farmacopea Europea, regulations already acknowledged by Italian legislation, the celiac is free from one of the many problems that can make his daily existence difficult.
Thanks to the greater attention paid by European and national institutions, it is quite likely that this result is only the first concrete action we have managed to achieve regarding celiacs’ rights to see the removal of various obstacles complicating their existence and hence the quality of their life. From the study by PHARMACOPEA EUROPEA:
Wheat starch can contain 0.3 % of total protein at most:
of which about 40 % is equivalent to gliadin
in 100 mg of wheat starch there are 0.3 mg of total protein
of which 0.12 mg of gliadin
0.3 x 40 % = 0.12
STARCH USED AS
AN ELUANT AT 13 %
TABLET WEIGHT in mg
WHEAT STARCH in mg
GLIADIN in mg
100
13
0.0156
300
39
0.0468
500
65
0.0780
1000
130
0.156
STARCH USED AS
AN ELUANT AT 10 %
TABLET WEIGHT in mg
WHEAT STARCH in mg
GLIADIN in mg
100
10
0.012
300
30
0.036
500
50
0.060
1000
100
0.120
STARCH USED AS
AN ELUANT AT 4 %
TABLET WEIGHT in mg
WHEAT STARCH in mg
GLIADIN in mg
100
4
0.0048
300
12
0.0144
500
20
0.0240
1000
40
0.0480
CONCLUSIONS
TABLET WEIGHT in mg
GLIADIN in mg
100
0.0048 – 0.0156
300
0.0144 – 0.0468
500
0.0240 – 0.0780
1000
0.0480 – 0.156
IN THE LIGHT OF THE DATA PRESENTED AND OFFICIALLY CONFIRMED BY THE MINISTRY OF HEALTH, THE NATIONAL SCIENTIFIC COMMITTEE OF THE AIC EXPRESSES THE FOLLOWING OPINION
As emerged during the “extended” meeting of the National Scientific Committee of the AIC, held in Rome on 7 November 2003, the subject of medicine was taken into consideration once again during the “narrow” meeting of the Scientific Committee that took place in Rome again on 6 February 2004.
The document regarding the relationship between medicines and celiac disease, sent by fax by the Ministry of Health on 5 February 2004, was made public by the AIC President Pucci.
This document states that the quantity of gluten present as an excipient in certain medicines is not a problem, given that 1 gr. of tablet can contain at most 0.156 mg of gliadin (a quantity notably inferior to what might be taken with therapeutic dietetic products).
Therefore, the National Scientific Committee of the AIC accepts what is communicated in the aforesaid document, (*) specifying nevertheless that if the medicines are given habitually, any individual hypersensitivity should be evaluated on a case-by-case basis.
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