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After the pharmaceutical scandal: the trial of the antihypertensive drug valsartan

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Munich (dpa) – The scandal made headlines in 2018: At the time it became known that many antihypertensive drugs based on the active ingredient valsartan were contaminated with the potentially carcinogenic substance N-nitrosodimethylamine (NDMA).

Some lots have been withdrawn. The starting active ingredient of the medicines that were withdrawn from the market at that time came from a Chinese producer.

Around four years later, this pharmaceutical scandal became a case for the Higher Regional Court (OLG) in Munich on Thursday. A 75-year-old man complained there for information because he developed cancer after taking a medication containing valsartan. He believes the drug caused a rare tumor in his stomach. In a second step, he also demanded compensation for pain and suffering. However, the partial proceedings were still pending in the regional court until the information issue was clarified.

The Munich I Regional Court granted his request for information last year, but only in part (23 O 8725/20 of October 19, 2021). Both he and the defendant pharmacist appealed against the sentence, which is why he is now facing trial in the next instance.

uncertainties about the drug

The representatives of the pharmaceutical company stated that it was questionable whether the medication that the plaintiff had consumed actually came from the contaminated batches. Many packages were removed from pharmacy shelves as a precaution. By the way, it is incomprehensible why the drug caused the tumor and not the “general risk to life” of a man older than 70 years.

According to the defendant’s representatives, studies only show a minimal increase in cancer risk after taking the contaminated blood pressure medication for six years, and the plaintiff only took the medication for three years. However, the presiding judge emphasized: “There is much to suggest that there could be such a connection.” He recommended that the parties reach an out-of-court settlement, which they now want to examine.

A study carried out by the Federal Institute for Drugs and Medical Devices (BfArM) in cooperation with the scientific institute of the AOK concluded last year that there was no overall increased risk of cancer due to the contaminated active ingredient. No overall increased risk of cancer was found for either long-term use of three years or as a function of dose.

Significant risk

However, looking specifically at liver cancer after prescription of contaminated valsartan, the study found a statistically significant, albeit slightly increased, risk. However, a direct causality cannot be derived from this and needs to be investigated further, the BfArM wrote.

Liver cancer is the most likely type of cancer after NDMA ingestion. However, special factors such as smoking, eating habits or genetic predisposition were not included in the study.

For the study, scientists evaluated data from 780,871 AOK members who were at least 40 years old at the beginning of 2012 and who had filled at least one prescription for a medicine containing valsartan between 2012 and 2017. Some of the remedies had been contaminated with NDMA, others are not. According to the BfArM, the medium- and long-term cancer risks have not yet been investigated due to the limited observation period.

extensive investigations

The valsartan scandal has tightened drug control mechanisms, as the BfArM announced: “The manufacturing processes were thoroughly examined,” the institute emphasized. The European Medicines Agency (EMA) set new limit values ​​in the wake of the scandal. According to the BfArM, pharmaceutical companies have had to take all possible measures in their manufacturing processes to prevent contamination.

The hearing at the Munich Higher Regional Court is not the first trial in the Valsartan scandal. Last year, the Higher Regional Court in Stuttgart dismissed the damages suit brought by a patient who had taken the drug and was therefore afraid of developing cancer after the scandal became known.

The Frankfurt Higher Regional Court, on the other hand, also ruled in favor of the plaintiff last year. If there is a 97 percent probability that a drug contaminated with a substance that can cause cancer has been taken, the person who subsequently developed cancer could request information from the drug manufacturer, the ruling said.

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