France. A recent survey of medicines containing the plasma volume expander, hetastarch [hydroxyethylstarch], and particularly Elohes 6% (molecular weight approximately 200,000) carried out by the French Agency for Health Products has identified 8 cases of acquired von Willibrand disease, a condition which is characterized by a prolonged bleeding time, a decrease in the plasma levels of von Willibrand factor with a reduction in the activity of the ristocetin co-factor, and a deficiency in coagulation factor VIII.
Three cases were fatal and two cases described haematomas with prolongation of the time of activated cephalin. All these effects were observed during the treatment with hetastarch (Elohes) of vasospasm secondary to a meningeal haemorrhage due to rupture of a cerebral aneurism in patients with no relevant previous history, in particular haematological. The Agency notes that the patients’ haemostatic state was normal on admission. Duration of treatment of more than four days appears to be a risk factor.
Furthermore, 9 cases of hepatic overload have been detected, which could induce or aggravate a portal hypertension.
The Agency has announced that the product information for products containing hetastarch will be revised with, in particular, a contraindication for the use of Elohes in patients with severe hepatic insufficiency, the stipulation of a maximum dose and a restriction on the duration of treatment, as well as instructions on the monitoring of haemostasis.
Reference: La Revue Prescrire Vol. 19, No. 196, p.431, June 1999.