The German Federal Health Office, the BGA, has banned distribution of an antiarrhythmic treatment made by eastern German company Arzneimittelwerk Dresden GmbH. The company says it has initiated an immediate recall of the drug, which is called Bonnecor (tiracizin HCl), as a result.
Bonnecor was introduced in 1989 in injectable and oral forms in the former German Democratic Republic. However, the BGA now says that interim results of long-term animal studies carried out since the launch have indicated a possible link between the drug's use and cancer.
Although no confirmed link between the animal studies and an oncogenic risk in man has been demonstrated, the BGA's view is that further use of the drug cannot be defended, particularly as there are many alternative treatments for arrhythmias already available on the German market.
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