ROXIAM WITHDRAWN DUE TO ADVERSE REACTIONS

The German Federal Health Office, the BGA, has banned distribution of Astra's antischizophrenia drug Roxiam (remoxipride). The product's marketing approval has also been cancelled by the BGA.

The BGA says that the withdrawal was due to several cases of changes in patients' blood which have been reported from abroad, including aplastic anemia, with life-threatening consequences (Marketletters passim). The marketing approval issued in Germany required regular monitoring of the blood-picture during therapy with Roxiam, which may be the reason why no cases of aplastic anemia related to the drug have been reported in that country, says the BGA.

Roxiam is either on the market or has been submitted for marketing approval in most European countries. Following the reports of serious adverse reactions in November of last year, Astra had recommended that precautions should be taken regarding the drug's use.