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Problems with contamination with sartan-containing drugs continue
Contamination of high blood pressure and diabetes medications with potentially carcinogenic nitrosamines has led to a number of drug recalls in recent months and manufacturers still seem to have difficulty avoiding such contaminants.
"The European Medicines Agency (EMA) continues to make efforts to prevent contamination in medicines," emphasizes the Federal Institute for Drugs and Medical Devices (BfArm). After strict, legally binding limit values for nitrosamine impurities in sartan-containing blood pressure agents were laid down in a European risk assessment process, it is now imperative that manufacturers comply with these specifications. However, appropriate control mechanisms are required to ensure this. Medicinal products affected include valsartan, candesartan, irbesartan, losartan and olmesartan.
What are nitrosamines?
"Nitrosamines are classified as probable human carcinogens (i.e. substances that can cause cancer)," explains the BfArM. Although we are exposed to small amounts of these pollutants every day, as they are also contained in food and water, for example, the amount taken in increases the health risk. Additional burdens caused by contaminated medicinal products are therefore extremely critical. "Their presence in medicinal products is largely avoidable" and corresponding contaminants are "unacceptable", according to the BfArM.
First evidence of the contamination almost a year ago
Nitrosamines were first detected in sartan-containing medicinal products in June 2018 and a number of medicines have been recalled since then to avoid unnecessary health risks for patients. "Batches affected were recalled from the pharmacies, patients and specialist circles were adequately advised on alternative treatment methods, and medicinal products from across the EU were subjected to additional tests to ensure that they did not pose unacceptable risks for the patients," reports the BfArM.
Manufacturers affected by diabetes medication
Furthermore, based on the experience gained from the European review of medicinal products containing sartan, an investigation was launched "with experts from the entire EU regulatory network, including national authorities, the European Directorate for Medicinal Products Quality (EDQM) and the European Commission" to examine how such incidents can be prevented in the future. For example, companies that use certain raw materials for the production of the diabetes drug pioglitazone should test the quality of the products in the future and introduce processes that rule out the presence of nitrosamine contaminants, especially nitrosodimethylamine (NDMA).
Further measures will follow
"This request is made after the detection of low NDMA values in a few batches of pioglitazone, which were manufactured by Hetero Labs in India and were within the strict limit values," explains the BfArM. There is no risk for patients if the limit values that were set for NDMA during the risk assessment process for medicinal products containing sartan are observed. Furthermore, the EMA will implement suitable measures to ensure that the manufacturers take precautions to avoid contamination and remain below the permissible limit values. (fp)