People take prescription medication to address serious medical conditions. In most cases, these drugs work as promised and can help people treat symptoms or even cure diseases. However, manufacturing errors in medications can put consumers and patients at severe risk. A recent international drug recall involving a potentially life-saving medication highlights this risk. A popular off-patent drug designed for decreasing blood pressure and reducing the risk of heart failure has been recalled in 22 countries due to the risk of cancer. However, patients in the United States will find that this drug is still readily available, as the Food and Drug Administration (FDA) has not, at this time, recalled recent batches of the drug.
Valsartan recalled due to carcinogen contamination
Valsartan is a drug created by Novartis that has since gone off-patent. This means that other producers may make the drug under different generic names. While this does a great thing for helping people with mediocre insurance access the best possible medications, it can also open up patients to the risk of corner-cutting competitors leaving them at medical risk.
Early in July 2018, more than 2,300 batches of the drug faced recall by 22 different countries. Germany, Spain, the United Kingdom and Greece are among the countries recalling the drug. The issue is an impurity in the recalled batches of the drug.
A change in the manufacturing process led to an organic chemical known to be a carcinogen in the pills. N-Nitrosodimethylamine (NDMA) is a chemical known to occur as a byproduct of certain chemical processes. Animal studies have shown that this chemical can cause tumors in the kidneys, liver and respiratory system.
The FDA has not recalled the drug, but it is important to note that the FDA often lags behind international agencies in addressing problems with medications and chemical compounds.
What happens when something designed to make you better makes you sick?
As a patient and a consumer, you have the right to safe and reliable products. If a company markets a drug as safe for human consumption, it should not contain known carcinogens. Contaminated drugs can have a dire effect on those people who are medically vulnerable. The patients who take unsafe drugs and later develop serious medical conditions may have the legal right to hold the drug’s manufacturer accountable.
Ideally, companies and government regulatory agencies would always put consumer protection above corporate profits. However, that is not the way that things work in the real world. Companies will often make changes to products without adequately testing them. If you or someone you love has suffered a severe medical event or developed an illness as the result of the contaminated or defective drug, you need to educate yourself about your legal options.