Spanish regulatory authority warns of blindness from German medicines

Spanish authorities report that a German drug should be responsible for the blindness of at least 13 patients. Also of "a case in Italy" is reported. In Germany, several batches of the drug had been recalled during the summer.
At least 13 people go blind
According to the authorities, more than a dozen people in Spain have lost sight of at least one eye after using a medicine. Altogether 41 cases are known so far, in which patients are affected by the application of the product used in surgery. This was announced by the Spanish Medicines Agency (AEMPS) over the weekend. According to a news agency AFP, 13 cases of amaurosis have been confirmed, ie a complete loss of vision in one eye. In addition, other impairments were reported, including vision impairment.

German drug under massive suspicion. Image: Dan Race - fotolia

Authority warned already in the summer before the means
AEMPS had already issued a warning at the end of June declaring that the funds of the German manufacturer Alamedics GmbH had been withdrawn from the market. Accordingly, samples were sent to a research institution in Spain for further analysis. It was said that there was cooperation in this regard with the laboratory in Dornstadt, Baden-Württemberg, as well as with the German authorities. In September, the French authorities stated that the product had been withdrawn from the market. In addition, the German laboratory spoke of "a case in Italy".

Sale of the drug was stopped
The French Drug Safety Authority (ANSM) had published on its website an e-mail translated into French by Alamedics CEO Christian Lingenfelder. The German Federal Institute for Drugs and Medical Devices published the information on the recall of the product "Ala Octa" in the summer. In the letter of 13 July Lingenfelder warned the dealers that the product was suspected of being responsible for a degeneration process of the retina. He also wrote in the e-mail: "Due to the length of time it takes to produce the results of the analysis needed to investigate the cause, the safety of the patient can not be determined with certainty.

As a precautionary measure, three batches are being recalled for which no clear statements have been made without carrying out further analyzes due to the planned analysis results. Until the facts are clarified, the distribution of the product to the specialized trade will be suspended for the time being. "According to the current news release, Alamedics was initially unavailable for commenting on the blindness in Spain. (Ad)