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How do contaminated drugs end up on the market?

For the many in Michigan who are taking medications containing valsartan or other angiotensin receptor blockers to control high blood pressure, the recent recall of these and other drugs due to contamination may be alarming. This is especially true since the impurities discovered in the contaminated drugs are known to cause cancer. Unfortunately, there is no easy answer since there are numerous ways in which impurities can reach the medicines many need to support their health and sustain their lives.

Makers of drugs containing valsartan issued a voluntary recall in 2018 after discovering that some contained impurities called nitrosamines. Nitrosamines are prohibited from existing in pharmaceuticals because they are known to cause liver cancer and other types of tumors that often metastasize rapidly. Investigations show that the dangerous impurities may have been contaminating drugs for four years or more. With such risks, how do the nitrosamines end up in the drugs undetected?

While the pharmaceutical companies continue to investigate the potential cause of contamination in this case, global studies show that nitrosamines may develop during the manufacturing process if sodium nitrate combines with certain ammonium salts, solvents or catalysts. Contaminated raw materials, which may come from multiple suppliers, may result in widespread impurities. It is possible that contamination of one drug may reach other drugs that are manufactured along the same line if employees do not follow proper protocol.

Tracing the exact cause of contamination can be complicated. Also complicated is the job of holding accountable the people or entities responsible for any injuries or deaths that result from the contaminated drugs. Those in Michigan who are suffering as a result of impurities in valsartan or other drugs would be wise to seek the advocacy of a skilled attorney.