[Information regarding adverse drug effects and treatment indications ("package inserts") exemplified by cervistatin (Lipobay)].
A worldwide frequently applied HMG-CoA-reductase-inhibitor ("statin") recently has been withdrawn from the market. This obviously has been caused by serious adverse events. The question is whether the package inserts sufficiently inform about the risks. But, although they list up numerous side effects, they lack informations concerning the frequency of them, so the patients when reading the package inserts become confused. Thus they have to rely on their doctors choice regarding the danger outlined in the inserts. In that respect packing inserts could be improved.
Braun
Robert N
RN
Arbeitsgemeinschaft zur Erforschung-der Allgemeinmedizin, Lüt-zowgasse 6/3/21, A-1140 Wien.
Halhuber
Max J
MJ
Hitzenberger
Gerhart
G
D016907:Adverse Drug Reaction Reporting Systems; D000924:Anticholesteremic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001317:Austria; D004305:Dose-Response Relationship, Drug; D004346:Drug Information Services / Q000592:standards; D004348:Drug Labeling / Q000592:standards*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D010353:Patient Education as Topic / Q000592:standards; D011725:Pyridines / Q000009:adverse effects* / Q000627:therapeutic use; D051437:Renal Insufficiency / Q000139:chemically induced; D012206:Rhabdomyolysis / Q000139:chemically induced
D000924:Anticholesteremic Agents; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011725:Pyridines; C086276:cerivastatin