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Directorate-General for Health and Food Safety
Question
The Committee is asked the following:
- Does the safety profile of benzyl alcohol support its use in parenteral medications intended for neonates ?
- Should the current contraindication for benzyl alcohol in the guideline on the excipients in the label and package leaflet of medicinal products for human use remain in its current form ?
- Does the safety profile and clinical experience of benzyl alcohol support the establishment of threshold dose levels below which the contraindication should not be labelled ?
Context of the question
The question is asked in the frame of a "Guideline on the excipients in the label and package leaflet of medicinal products for human use" approved by the Pharmaceutical Committee which became applicable from 1st September 1997. According to this guideline, any medicinal product containing benzyl alcohol is contraindicated for infants or young children up to 3 years old.
Assessment
The Scientific Committee of Medicinal Products and Medical Devices is of the opinion that insufficient information was provided to address the questions asked. Additional information is required regarding: (i) the medicinal products for human use that contained benzyl alcohol, prior to the contraindication applicable from 1st September 1997 ; (ii) the benefit for human beings expected from the addition of benzyl alcohol to some medicinal products ; (iii) the scientific data on which was based the contraindication approved by the Pharmaceutical Committee in 1997 ; (iv) recent toxicity data, if available, in particular those concerning the suspected carcinogenicity and teratogenicity of benzyl alcohol.
The Committee is asked the following:
- Does the safety profile of benzyl alcohol support its use in parenteral medications intended for neonates ?
- Should the current contraindication for benzyl alcohol in the guideline on the excipients in the label and package leaflet of medicinal products for human use remain in its current form ?
- Does the safety profile and clinical experience of benzyl alcohol support the establishment of threshold dose levels below which the contraindication should not be labelled ?
Context of the question
The question is asked in the frame of a "Guideline on the excipients in the label and package leaflet of medicinal products for human use" approved by the Pharmaceutical Committee which became applicable from 1st September 1997. According to this guideline, any medicinal product containing benzyl alcohol is contraindicated for infants or young children up to 3 years old.
Assessment
The Scientific Committee of Medicinal Products and Medical Devices is of the opinion that insufficient information was provided to address the questions asked. Additional information is required regarding: (i) the medicinal products for human use that contained benzyl alcohol, prior to the contraindication applicable from 1st September 1997 ; (ii) the benefit for human beings expected from the addition of benzyl alcohol to some medicinal products ; (iii) the scientific data on which was based the contraindication approved by the Pharmaceutical Committee in 1997 ; (iv) recent toxicity data, if available, in particular those concerning the suspected carcinogenicity and teratogenicity of benzyl alcohol.
