AMC must stop taking metabolic drugs Indoor

According to the IGJ, it used a raw material not in accordance with the Pharmacopoeia, a European manual. The substance contained too high concentrations of two impurities, so the safety was not fully guaranteed. In addition, the UMC of Amsterdam has also provided information on the drug in the form of advertising, which is prohibited. The institution therefore issued two warnings

. It was CDCA substance against CTX disease, with which less than a hundred people were treated. The price of the original agent of the ditto maker had soared, which the UMC of Amsterdam decided to do itself. This can be done under certain conditions and by experts, although on a small scale and for particular patients.

The drug was tested in Belgium, where the laboratory did not detect any imperfections. The Dutch institute RIVM however found the impurities, factors 8 and 4 above the allowed standards (after all, the drugs often contain impurities). Production had already been discontinued as a precautionary measure and the hospital arranged for patients to receive the expensive, original product again.

According to the UMC of Amsterdam, this warning is not unexpected and is a direct consequence of the supplier's complaint against us. submitted to the IGJ & # 39;. The hospital reports that the raw material has been the subject of extensive testing. "We are convinced that we have met all the requirements and all the rules, because we did not go out of the ice overnight" (19659002). future, the UMC is free to take drugs, but must simply meet the European requirements.They are strict, but do not exist for nothing, according to the inspection.The hospital always says that it has a number of options to stay open so that CDCA remains available for this group of patients dependent on it. "