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Blood pressure medication recalled by FDA for carcinogen risk

Posted January 16, 2020 5:00 a.m. EST

In July 2018, the FDA announced a recall of Valsartan medications from certain manufacturers due to impurities detected in the drugs. (fortton/Big Stock Photo)

This article was written for our sponsor, Whitley Law Firm.

If you are taking medication, it is important to know all the risks and side effects associated with it.

The United States Food and Drug Administration has been and continues to recall Valsartan medications due to the discovery of cancer-causing agents in the drugs. Valsartan is a common medication that is used to control blood pressure and reduce the risk of heart failure.

In July 2018, the FDA announced a recall of Valsartan medications from certain manufacturers due to impurities detected in the drugs. Tests discovered that certain Valsartan drugs were contaminated with NDMA, and later, NDEA.

Both NDMA and NDEA are toxic chemical compounds proven to be carcinogenic by the U.S. Environmental Protection Agency.

Since last year, more batches have been recalled and the FDA's recall of Valsartan drugs continues to expand to more manufacturers.

"NDMA's components are difficult to find, but the FDA worked to develop a test that could detect the quantity present in a medication so that it can further expose drug impurities," explained Matthew Bissette, an associate attorney at Whitley Law Firm in Raleigh who represents plaintiffs in products liability and personal injury cases. "Unlike most impurities in drugs, the NDMA in Valsartan is a genotoxic impurity that can potentially cause harm even at low levels."

The FDA suspects that a maker of the recalled Valsartan drug, a Chinese manufacturer named Zhejiang Huahai Pharmaceutical Co. Ltd., changed the way it was making the drug, which resulted in its contamination with NDMA.

Several other manufacturers, such as Aurobindo Pharma USA and Torrent Pharmaceuticals, have voluntarily recalled their own Valsartan products.

Whitney Butcher, a partner at Whitley Law Firm, said the additional recalls are concerning. Butcher works primarily with clients in the dangerous drug and defective medical device practice area.

"What we believe can happen with the NDMA ingredients is that they can cause various cancers of the digestive tract – so esophageal cancer, stomach cancer, intestinal issues, liver cancer," she said. "Unfortunately, we have had a number of people who have taken the Valsartan drug reach out to us and tell us that they’ve been diagnosed with one of these types of cancer."

While the exact cancer risk of contaminated pills is unknown, the FDA believes the risk is low, but still advises switching your medication when you are able.

"It is estimated that if 8,000 people took the highest dose of Valsartan [320 milligrams] containing NDMA from these recalled batches daily for four years, there may be one additional case of cancer over their lifetimes," CNN reported. "Many patients take a much lower dose of Valsartan, and therefore their risks are theoretically much lower."

Doctors do not recommend abruptly stopping your medication. Since Valsartan is used to treat serious medical conditions, the FDA is advising patients who are currently taking recalled Valsartan medications to continue taking their medicine until an alternative drug, therapy or solution is prescribed by their healthcare professional.

People who are taking Valsartan drugs issued by Zhejiang Huahai Pharmaceutical Co. Ltd., Mylan or any drug classified as an ARB blood pressure reducer, should verify with their pharmacist or doctor whether the medication contains impurities.

"As patients and consumers, we shouldn't have to worry about whether a product our doctor is prescribing or something we are selecting from a shelf is safe or not," Bissette said. "Even if something is deemed 'low-risk', it's still a risk and could end up having consequences down the road."

He added, "Pharma companies create life-saving medications, but they also make tremendous profits. When drug companies dispense something that has harmful effects, even if unintentionally, they need to be held accountable."

The Valsartan lawsuits have been consolidated in federal court in New Jersey. Butcher anticipates that more cases will be filed over the coming months.

Any person who has taken a recalled Valsartan drug and believes they have been harmed by its impurities should seek legal counsel with a lawyer who specializes in drug-based claims and lawsuits to pursue compensation for any damages caused by the medication.

This article was written for our sponsor, Whitley Law Firm.