Impurities of high blood pressure and diabetes resources

Furthermore, problems with impurities in sartanhaltigen medicines

The contamination of high blood pressure and Diabetes medications with potentially cancer-causing nitrosamines has led in recent months to a series of drug-Rückufen and still, the manufacturers seem to have difficulties to avoid such contamination.

“The European medicines Agency (EMA) continues to make efforts in order to prevent impurities in medicinal products”, stressed the Federal Institute for drugs and medical devices (BfArm). After a European risk assessment procedures, strict legally binding limits for nitrosamine impurities in sartanhaltigen blood pressure have been set, is now compliance with these specifications by the manufacturer is mandatory. However, there is a need for appropriate control mechanisms to ensure this. To see the medicinal products valsartan, Candesartan, Irbesartan, Losartan, and Olmesartan.

What are nitrosamines?

“To be classified nitrosamines as probable human carcinogens (i.e., substances that can cause cancer),” says the BfArM. Although we are exposed to everyday small amounts of these pollutants, since they are included in, for example, in food and water, but also the health risk increases with the intake. Additional loads due to contaminated medicinal products are therefore extremely critical. “Their presence in pharmaceutical products is largely avoidable,” and the corresponding contamination are “unacceptable”, so the message of the BfArM.

The first evidence of contamination, almost a year ago

For the first time, nitrosamines were detected in June 2018 in sartanhaltigen medicines and since then, a whole series of medications have been recalled, so as to avoid unnecessary health risks for patients. “The affected batches were recalled from the pharmacies, patients and professionals were adequately advised about alternative treatment methods and medicinal products across the EU have been subjected to additional Tests to ensure that they pose no unacceptable risks for the patients”, reported the BfArM.

Manufacturer of Diabetes medications affected

Furthermore, it should be based on the experience of the European Review of sartanhaltigen medicines an investigation “with participation of experts of the entire EU regulatory network, including national authorities, the European Directorate for the quality of medicines (EDQM) and the European Commission”, initiated in order to examine how such incidents can be prevented in future. For example, should also use companies that certain starting materials for the production of the diabetes drug pioglitazone, in the future, the quality of the products to test and implement processes that rule out the presence of nitrosamines, especially nitrosodimethylamine (NDMA), impurities.

Further measures to follow

“This request is made after the detection of low NDMA values in a few of the pioglitazone-batches, which were manufactured by Hetero Labs in India and within the strict limits were,” explains the BfArM. A risk to patients will not exist in the case of compliance with the limits established for NDMA during the risk assessment process to sartanhaltigen medicines. Furthermore, the EMA will implement appropriate measures to ensure that manufacturers take precautions to avoid contamination and the permissible limit values. (fp)