Authorities consider ‘precautionary restrictions’ on 6 veterinary products

It has been confirmed that authorities have commenced the procedure to “consider precautionary restrictions” on the use of veterinary medicinal products containing diethanolamine.

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Veterinary Use (CVMP) has recently reviewed and given an opinion on the risk to consumers from the use of diethanolamine in veterinary medicines.

The CVMP, the committee responsible for preparing opinions on all questions concerning veterinary medicines in the European Union, considered that it is not appropriate that the excipient (diethanolamine) is included in the list of substances considered as not falling within the scope of Regulation 470/2009 – otherwise known as the ‘out of scope’ list.

In a statement, the Health Products Regularity Authority (HPRA) explained that this regulation legislates for the use of substances that are administered to food-producing animal species.

Continuing, it said: “The opinion of the CVMP on July 19, 2018, which is directed at all EU member states, is that it is not possible to rule out a risk for consumers of food produced from animals treated with veterinary medicinal products containing diethanolamine.

Consequently, as a precautionary measure, the HPRA has commenced a review process that will consider the possible suspension of the marketing authorisations for the six products concerned that are marketed in Ireland.

“This procedure – which commenced on July 27, 2018 – provides for consideration by the HPRA of representations from the companies that are directly concerned by this opinion of the CVMP, as well as consideration of the matter by the HPRA’s independent expert advisory committee – the ACVM.”

Further updates will be issued during the course of this review process.

The six products involved in this review process are:
  • Finadyne 50 mg/ml solution for injection;
  • Cronyxin Injection 50 mg/ml solution for injection;
  • Flunazine 50 mg/ml solution for injection for cattle, horses and pigs;
  • Flunixin Injection;
  • Dugnixon 50 mg/ml solution for injection for cattle, pigs and horses;
  • Tribrissen Oral Suspension.

These are prescription-only medicines, the HPRA added.

It has also been confirmed that no recall of these products is “considered necessary at this time” and that they can continue to be prescribed and used by veterinary practitioners.


At the beginning of this year, the CVMP removed diethanolamine from the ‘out of scope’ list “on the basis of concerns relating to carcinogenicity and genotoxicity”.

Continuing, the HPRA explained: “Diethanolamine has been shown to have carcinogenic potential in mice and the available genotoxicity data did not allow a conclusion to be drawn on the relevance of the findings for humans.”

In March of this year, a public consultation was initiated by the CVMP “in order to seek scientific data for use in the the review of the consumer safety assessment of the substance,” the HPRA said.

While the newly available data indicates that diethanolamine is not likely to be a DNA reactive carcinogen, when adopting conservative estimates of exposure in a worst case scenario, calculations indicate that diethanolamine could represent an unacceptable risk to consumers.

“If the substance is to be further used in veterinary medicinal products, the substance will need to be approved as safe for consumers,” the authority concluded.