WRITTEN QUESTION No. 1538/97 by Hiltrud BREYER to the Commission. Phosphate ester poisoning due to the use of Tiguvon (Fenthion) manufactured by Bayer Leverkusen
C 21/66 EN Official Journal of the European Communities 22. 1. 98 pharmatoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (1). A product used for ectoparasitic control may have potential neurotoxic properties at certain concentrations and elevated doses. Products which may exhibit neurotoxic effects may be authorised and such effects may lead to organic lesions with subsequent behavioural changes if the product is abused. The safety of the recommended dose is to be considered in the assessment of the safety file submitted to the competent authority to support the application for market authorisation (2). If no such effects are seen at the recommended dose and if the product is used as indicated on the label there should be no cause of concern. The absence of reports on serious adverse reactions indicates that this is currently the case. (1) OJ 317, 6. 11. 1981, as amended by Council Directives 90/676/EEC OJ 373, 31. 12. 1990, and 93/40/EEC OJ 214, 24. 8. 1993. (2) Provision concerned. (98/C 21/156) WRITTEN QUESTION E-1538/97 by Hiltrud Breyer (V) to the Commission (5 May 1997) Subject: Phosphate ester poisoning due to the use of Tiguvon (Fenthion) manufactured by Bayer Leverkusen The flea-repellant Tiguvon (Fenthion) manufactured by Bayer Leverkusen can be administered in different forms. Tiguvon 10 is intended for cats over 2 kg in weight. The use of Tiguvon 20 is recommended for dogs weighing between 3 and 10 kg, while dogs with a body weight of more than 10 kg should be treated with Tiguvon 20 G. People who have repeatedly treated their pets with Tiguvon (Fenthion) have suffered serious phosphate ester poisoning. As it was unable to answer my Question E-1470/96 (1) on the same subject, I would ask the Commission to answer the following questions as a matter of urgency: Is the Commission aware of any research findings that reveal the extent of the danger to pet-owners, especially children, whose health may be damaged even by small quantities of toxins and who, at their young age, cannot be assumed to act responsibly? (1) OJ C 345, 15. 11. 1996, p. 76. Answer given by Mr Bangemann on behalf of the Commission (23 June 1997) Following the Honourable Memberís earlier written question E-1470/96 the Commission has asked the pharmacoviligance working party of the scientific committee for the evaluation of veterinary medicinal products to report on adverse effects of the product. No adverse effects have been reported since then. (98/C 21/157) WRITTEN QUESTION E-1546/97 by Hiltrud Breyer (V) to the Commission (5 May 1997) Subject: Phosphate ester poisoning due to the use of Tiguvon (Fenthion) manufactured by Bayer Leverkusen The flea-repellant Tiguvon (Fenthion) manufactured by Bayer Leverkusen can be administered in different forms. Tiguvon 10 is intended for cats over 2 kg in weight. The use of Tiguvon 20 is recommended for dogs weighing between 3 and 10 kg, while dogs with a body weight of more than 10 kg should be treated with Tiguvon 20 G. People who have repeatedly treated their pets with Tiguvon (Fenthion) have suffered serious phosphate ester poisoning. As it was unable to answer my Question E-1470/96 (1) on the same subject, I would ask the Commission to answer the following questions as a matter of urgency: