More On Injectable Losec Suspension IN Germany

As reported in the Marketletter last week, the German Federal Health Office, the BAM, has cancelled the marketing approval granted to Astra for the injectable version of its antiulcerant omeprazole, which is sold under the brand names of Antra and Gastroloc, until July 31, 1995. Oral and infusion versions of the drug are not affected by the ban.

In addition to the suspension, Astra must add a warning to Patient Package Inserts of all other formulations of omeprazole marketed in Germany. This warning will make reference to the fact that patients treated with high doses of the product for long periods in isolated cases suffered damage to their vision. Therefore physicians should adhere strictly to dosage guidelines.

The BAM's move is curious in the light of the recent meeting of the European Union's Committee on Proprietary Medic-inal Products, which could find no definitive causal link between the drug and reported visual and auditory disturbances, and merely suggested that some reference to these should be made in the drug's labeling (Marketletter August 1). Other EU states have not seen the need to impose similar restrictions on omeprazole.