The Danish Medicines Agency is presently reviewing which medicines containing dibutyl phthalate (DBP) are still on the Danish market.
In 2006, a similar review was performed, and the manufacturers of DBP-containing products were then ordered either to phase out DBP or to update the product information with information about the DBP content and a warning about its potentially harmful effects on foetuses.
In 2006, nine products on the market contained DBP. The DBP content in six of these products has now been replaced by another plasticiser.
At present, there are four products on the market that contain DBP, and a further two products have been licensed, but are not marketed yet. The products are:
Marketed:
- Litarex®
- Modifenac®
- Mesasal®
- Vivotif®
Not marketed:
DBP is a plasticiser used as an excipient in the coating of medicines. As such, DBP is not part of the medicine’s active substance. In the factbox to the right, you can find an DBP opinion made by the European Food Safety Authority (EFSA).
Based on animal trials, DBPs are suspected of disrupting the hormone system and to cause defects in the sexual glands of boys in particular. The Danish Medicines Agency furthermore highlights the following:
- It has not been documented that DBP may cause cancer.
- The Danish Medicines Agency has ensured that the summaries of product characteristics for the above-mentioned medicines include information about the DBP content and its possible reproductive toxicity.
As part of our review, we are investigating if new knowledge has emerged about the potentially harmful effects of DBP. In this connection, we will consider if the case should be raised in the EU once again.
It is important that patients do not stop their treatment with any of the above-mentioned products. Patients who are concerned should consult their own doctor if they need to discuss treatment alternatives. In the case of Mesalal® and Modifenacs®, there are identical medicines with no DBP-content available on the market. This is also the case for Asacolitin® and Claversal®, which are not yet on the market.
For further information, please contact Senior Director of Division Per Helboe, tel. +45 4488 9275.
Danish Medicines Agency, 1 October 2009
