Warnings about the side-effects of atypical antipsychotic drugs
11.10.2006
WRITTEN QUESTION E-4501/06
by Alfonso Andria (ALDE)
to the Commission
There have been many instances of atypical antipsychotic drugs marketed in Europe — such as Zyprexa (Olanzapine) — producing dangerous side-effects not mentioned in the accompanying leaflet. They include a number of particularly severe side-effects, such as loss of suppleness, a slowing-down of reflexes, increased anxiety, excessive weight gain, reduced libido, an increased risk of diabetes and the danger of death from even a mild heart attack, loss of self-confidence, a reduced capacity to take decisions, loss of volition and depression. Since most of the drugs consist of recently introduced compounds, there are as yet no long-term studies to show their positive and negative consequences. Furthermore, both Directive 92/27/EEC[1] on the labelling of medicinal products for human use and on package leaflets and Directive 2001/83/EC[2] on the Community code relating to medicinal products for human use specifically state that package leaflets must contain certain information, including a description of all side-effects. Finally, in the United States around 8000 patients have brought legal proceedings against Eli Lilly, the pharmaceutical company that produces the antipsychotic Zyprexa. They complained of the lack of detailed warnings about a number of the drug’s side-effects and the manufacturer has paid out USD 690 million in order to settle most of the cases involving the drug.
Can the Commission say what measures it will take with regard to drugs such as Zyprexa (Olanzapine) that do not meet Community legal requirements regarding warnings about side-effects that may seriously harm the physical and mental health of European citizens?
OJ C 329, 30/12/2006