In 2018, a huge scandal rocked the world of medicine. Valsartan, a popular blood pressure drug, was found to be contaminated with a chemical called N-nitrosodimethylamine (NDMA) that could cause cancer. This news was a shock to millions of people around the world, especially those who relied on valsartan to manage their blood pressure.
Many people who used valsartan were worried, particularly those who had been taking it for a long time. The potential risks were serious, as the contamination could increase their chances of developing cancer.
If you or someone you know has been impacted by this, you might want to get help to file a Valsartan cancer lawsuit.
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The Source of Contamination
The contamination problem started when Zhejiang Huahai Pharmaceuticals changed its production method in 2012. They began using a solvent called dimethylformamide (DMF) to help create the tetrazole ring.
The contamination was initially detected by the European Medicines Agency (EMA) during routine testing. The agency found that certain Valsartan tablets contained NDMA at levels that raised serious health concerns.
As a result, a massive recall was initiated, and this recall impacted many different pharmaceutical companies and their products.
The contamination problem was not confined to just one manufacturer or batch. It became apparent that the issue was widespread, involving several companies and various countries.
The Chemistry Behind the Contamination
Valsartan is a type of medication called an angiotensin II receptor blocker (ARB), which helps lower blood pressure by blocking a specific hormone. To make Valsartan, a chemical structure known as a tetrazole ring is created using DMF.
The issue with DMF is that it can break down into another chemical called dimethylamine (DMA). If DMA then comes into contact with nitrous acid, which can form during production, NDMA is produced.
This reaction is the main reason for the NDMA contamination found in Valsartan.
How the Contamination Spread
Making Valsartan involves several steps and many different companies. First, the active ingredient (API) is produced. Then, various companies turn this ingredient into tablets or capsules.
These products are repackaged and sold under different brand names. This complex supply chain made it hard to track and manage the contamination.
Even though the initial problem was traced back to Zhejiang Huahai Pharmaceuticals, further investigation revealed that other companies were also affected. These companies had bought Valsartan from Zhejiang Huahai and later had to recall their products.
Key Companies Involved in the Contamination:
- Teva Pharmaceuticals
- Prinston Pharmaceutical Inc.
- Torrent Pharmaceuticals
- Mylan Pharmaceuticals
- Aurobindo Pharma
The contamination was not limited to the United States. Valsartan products affected by the NDMA contamination were also distributed to several countries, including:
- Austria
- Belgium
- Canada
- France
- Germany
- Italy
- Spain
- Sweden
The Response and Recalls
When the contamination was discovered, a series of recalls were quickly put into action. The recalls were challenging due to the large number of affected products and the complicated supply chain.
Not all batches of Valsartan were contaminated, so the recalls were based on specific batch numbers.
How the recall happened:
- Identifying Affected Batches: The first step was to determine which Valsartan batches were contaminated. This involved testing and analyzing samples from different sources.
- Notifying Stakeholders: After identifying the contaminated batches, notifications were sent to pharmaceutical companies, wholesalers, and pharmacies.
- Public Awareness: Patients were advised to check their medications and contact their healthcare providers if they had any of the recalled Valsartan products.
- Resolution and Remediation: To stop an incident like this from happening again, they worked on ways to improve manufacturing processes and quality control measures.
