ROBAPHARM DRUG BANNED IN GERMANY

The German Federal Health Office has ordered a temporary ban on the marketing of an injectable product, Arumalon, which is sold by Deutsche Robapharm GmbH for the treatment of degenerative changes in joints.

Commenting on its decision, the BGA said that in the light of new information, the product "demonstrates no suitable pharmaceutical qualities," and thus gives rise to the suspicion that there may be "medically unacceptable risks in its use."

Arumalon is an extract of animal origin and has been under BGA scrutiny for some time. In October 1987 it was assessed negatively in terms of use-risk factors, and at a later public hearing in May 1988 on the use of so-called chondroprotectives, no clear conclusions emerged. The result of this hearing was the insertion of stricter warning notices on the product package insert.