Valsartan Recalled After Testing Positive for Potentially Cancer-Causing Chemicals

Beginning in July, the U.S. Food and Drug Administration (FDA) has issued a series of recalls
for multiple medications that contain the drug valsartan after two likely carcinogenic chemicals
were found in valsartan batches that had been imported to the United States from China.

Often combined with other drugs such as hydrochlorothiazide to create multi-symptom treating
medications, valsartan works to lower blood pressure and counteract the risk of heart failure by
widening and relaxing a patient’s blood vessels—enabling the heart to pump blood around the
body more easily. Approved by the FDA in 1997 to treat high blood pressure, it is typically used
as part of a lifelong treatment plan as individuals who suffer from long-term hypertension have a
significantly increased chance of suffering from heart disease.

One manufacturing company that had its valsartan recalled by the FDA in mid-July is China-
based Zhejiang Huahai Pharmaceuticals (ZHP). The FDA also banned imports of both active
pharmaceutical ingredients and finished drug products from the company. A second company in
China by the name of Zhejiang Tianyu Pharmaceutical came into the spotlight shortly after when
it lost its authorization to manufacture valsartan as a result of a known carcinogenic being
detected in their supply at low but potentially harmful levels.

The potentially carcinogenic drugs identified in the tainted batches of valsartan include N-
nitrosodimethylamine (NDMA), which was formerly used in the production of rocket fuel and can
lead to symptoms such as headaches, dizziness, jaundice, enlarged liver or kidney, and
reduced lung function, as well as the research chemical known as N-Nitrosodiethylamine
(NDEA) which can cause liver damage, liver tumors, and low platelet counts with long-term
exposure.

These recalls affect millions of people. In the U.S. alone, 29 percent of adults suffer from
hypertension and could be relying on such medication. Additionally, the recalls cover valsartan
supplies in Canada, the European Union, India, and more than 20 other countries. The
European Medicines Agency (EMA) has stated that there could be one extra case of cancer for
every 5,000 patients taking the ZHP valsartan due to the contamination, which is most likely due
to a change in the manufacturing process that dates back as far as 2012.

Regardless of the specific cause, there is no acceptable reason for so many patients to be
exposed to such dangerous impurities at any level. Our law firm of Childers, Schlueter, & Smith
is well-versed in drug and medical device litigation and might be able to help you or a family
member who might have taken contaminated valsartan for any period of time. If you have
questions, please give us a call at 1-800-641-0098. All initial inquiries are free of charge and without obligation.