A commonly prescribed drug is now being recalled after tests detected traces of a chemical that can potentially cause tumors and cancer. How did this happen?
On July 5, the European Medicines Agency announced that it is reviewing batches of valsartan after a testing revealed that they contained an impurity, which could pose potential cancer risks.
Specifically, the agency is reviewing the valsartan that was supplied by Zhejiang Huahai Pharmaceuticals in Linhai, China. It was found to contain N-nitrosodimethylamine or NDMA, a substance considered a probable human carcinogen by the U.S. Department of Health and Human Services.
According to EMA, the presence of NDMA in the valsartan was unexpected, and possibly due to changes made in the way it is being manufactured. Still, while investigations are underway, pharmacies are advised to recall drugs with the active ingredient valsartan.
Though products in the United States are so far unaffected by the recall, 2,300 batches of valsartan sent to Austria, Belgium, Bulgaria, Bahrain, Bosnia and Herzegovina, Canada, Croatia, France, Finland, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Malta, The Netherlands, Norway, Poland, Portugal, Sweden, and Spain are involved.
Information For Patients
In light of the recall, patients are advised not to abruptly stop taking their valsartan medications. Instead, they should contact their healthcare providers if they have any concerns or questions regarding the recall. It’s worth noting that not all valsartan medications are affected by the recall, but only some that were sent to Europe.
That said, patients may be prescribed with different medications on their next prescription while investigations are underway. The EMA is assessing whether the impurity discovered poses any risks for patients, and will provide new information when it has become available. The review will focus on the valsartan from Zhejiang Huahai Pharmaceuticals, but may also cover other valsartan medications that may have been affected.
“Our highest priority is to ensure that the medicines you take are safe,” said Dr. Sam Atkinson of the Medicines and Healthcare Products Regulatory Agency.
Valsartan And NDMA
Valsartan is an active ingredient in many heart medications to treat high blood pressure, heart failure, and recent heart attacks. It is available as a stand-alone drug, or as an active ingredient in combination with other active substances.
NDMA, on the other hand, is a semivolatile organic component that is a member of a family of potent carcinogens. It was formerly used in the production of rocket fuel and antioxidants and can be unintentionally produced from chemical reactions in industrial settings.
In past animal studies using various species, it was found that exposure to NDMA caused tumor growth in the liver, kidney, blood vessels, and respiratory tract.