EMEA scientific committee to examine safety of certain excipients
The European Commission is to ask the European Medicines Agency's scientific committee for an opinion on the safety of certain excipients that could be carcinogenic or mutagenic.
The European Commission is to ask the European Medicines Agency's scientific committee for an opinion on the safety of certain excipients that could be carcinogenic or mutagenic.
The Commission's decision comes after several members of the European Parliament expressed concern over a recent controversy in Germany concerning the use of dibutyl phthalate (DBP), an excipient found in many widely available medicines which is suspected of causing malformations in utero.
A declaration from the Commission's enterprise and industry directorate says: "In view of the risks of carcinogenic, mutagenic and toxic substances to reproduction, the Commission will request the Committee for Medicinal Products for Human Use of the European Medicines Agency to draw up an opinion on the use of these categories of substances."
The Commission will transmit the opinion of the Committee to the European Parliament and the Council and six months following this opinion, will inform the Parliament and member states of any action that the Commission considers necessary.
Euro MPS say that they are now waiting for the Commission's declaration to be followed by concrete action.
"We welcome the official declaration with satisfaction..and we are expecting concrete results from the Commission," said French Euro MP Francoise Gros-setete (EPP-ED) at a parliamentary plenary session on Wednesday.
DBP is present in about 50 widely-used medicines in Germany, including certain formulations of diclofenac, nifedipine and even omeprazole. Half of the products are sold without prescriptions.
The controversy arose in March, when scientists questioned on a German television programme confirmed that this excipient, whose use is forbidden in cosmetics and children's toys, could be the cause of genital malformations found in newborn baby boys.
The German medicines agency, the BfArM, had reacted by saying that there was no acute danger for patients taking products containing this excipient, even for pregnant women, whose babies were unlikely to be affected by this product.