Answer to a written question on Medicines and side effects on the liver

By European Parliament Register June 20,2014

Medicines and side effects on the liver - Question for written answer E-005505/2014 to the Commission Rule 117 Sergio Paolo Francesco Silvestris (PPE).

Sergio Paolo Francesco Silvestris explained that an international congress held in London has raised the issue of damage to the liver as a result of taking medicine. Antibiotics have been deemed to be the main culprit, but herbal medicines are not completely innocuous owing to the toxic substances that remain, albeit as a trace, in the solution. While it is difficult to define the problem in quantitative terms, the figures are nonetheless significant as regards liver problems arising after taking medicines (primarily antibiotics).

And, consequently, asked the Commission to:

  1. provide information and indicate any studies on the damage caused to the liver as a result of taking medicines?
  2. indicate any measures taken by the EU to facilitate monitoring of the side effects of medicines on the liver?

20 June, 2014, the following answer was given by Mr Borg on behalf of the Commission:

Medicines can be placed on the EU market only after their quality, safety and efficacy have been evaluated and it is concluded that there is a positive benefit-risk balance for their use. Potential side effects of medicinal products are mentioned in the accompanying product information.

After the initial authorisation, the safety of a medicine is followed during its whole life-cycle. Within the EU there are mechanisms to collect and monitor reports of suspected adverse reactions in patients following the use of a medicine. Suspected adverse reactions can be reported by healthcare professional or patients themselves to the national competent authority in their Member State. The European Medicines Agency's Pharmacovigilance Risk Assessment Committee assesses safety signals related to use of medicines[1] and when necessary make recommendations for amendment of the marketing authorisation, such as updates of the product information.

The Commission is not in a position to provide an overview of the large body of scientific studies on medicines-induced liver injury. In FP7[2] several projects have been supported that address prediction of toxicity of drugs including drug-induced liver injury. These projects are notably being supported within the Innovative Medicines Initiative[3],[4],[5]. Also in the remainder of the programme some projects have been supported, for a total EU financial contribution of more than EUR 57 million.

[1] Further information on PRAC signal management procedures is available on the EMA website

[2] Seventh Framework Programme for Research and Technological Development (2007-2013)