According to the European Medicines Agency (EMA)—the equivalent to our U.S. Food and Drug Administration (FDA)—contamination at the manufacturing center for Zhejiang Huahai Pharmaceuticals in China may possibly be linked to valsartan cancer risk and potential liver damage.

N-nitrosodimethylamine (NDMA) was found in the hypertensive drug valsartan which is commonly given to patients in the period of recovery following serious cardiac arrest to control blood pressure. NDMA has been identified by some health authorities as a probable human carcinogen, meaning that patients taking valsartan may face a valsartan cancer risk.

Since this valsartan cancer risk has been identified, there has been an effort on the part of drug oversight agencies like the EMA, its United Kingdom (UK) counterpart, and the FDA to get valsartan and valsartan HCTZ out of distribution.

According to a recent CNN article, in July 2018, 22 countries have been involved in the attempt to get the potentially contaminated heart medication pulled from the shelves of pharmacies. The tainting NDMA was discovered by the China pharmaceutical company itself and the recall notice was released on July 13.

By July 16, the U.S. stock of valsartan had been pulled from domestic pharmacies and totaled a loss of $20 million for the Chinese pharmaceutical enterprise in fiscal year 2017.

This event has caused a public relations nightmare for the Chinese pharmaceutical industry, with concurrent scares concerning 250,000 doses of a faultily-made vaccine for diphtheria and tetanus and 100,000 doses of a substandard rabies vaccine.

Valsartan Cancer Risk and Liver Compromise

Valsartan belongs to a class of medications known as angiotensin II receptor agonists which open up the blood vessels associated with the body’s circulatory system to allow for maximum, unimpeded flow after a heart attack.

The FDA approved it for adults and even for children six years old and above. It is very disconcerting to hear that a medication that has been attributed with the ability to reduce the risk of death in post-myocardial infarction patients has likely been tainted to the point of causing valsartan cancer risk in recipients.

Researchers have also known of a possible connection between valsartan and liver damage. Some patients have taken the drug and had to stop because of demonstrating signs that their liver was compromised such as abdominal pain, nausea, enlargement of the area of the abdomen where the liver is located, jaundice (a yellow-orange tint to the skin), and other visible skin changes.

The news that several sources of valsartan may have been contaminated with NDMA is all the more alarming for those with this liver damage. The FDA recommends that patients who are currently taking the hypertensive medication continue to take it until they can consult with their prescribing physician. This may be a matter of life and death.

Patients who have developed cancer after being exposed to valsartan  cancer risk may have a legal claim against the drug’s manufacturers.