The FDA has recalled a wide range of valsartan medications, saying the common blood pressure medication could be contaminated with a cancer-causing chemical. Laboratory tests found unacceptably high levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen, in batches of valsartan manufactured by two companies: China’s Zhejiang Huahai Pharmaceuticals and India’s Hetero Labs Limited.
FDA Recalls Contaminated Heart Medications
Valsartan (sold under the brand name Diovan) is a key medication in the fight against high blood pressure and congestive heart failure, as well as a potent protective measure in the wake of a heart attack. First developed by Sandoz and released to the market over a decade ago, valsartan is now available in numerous generic formulations. It can often be found paired with hydrochlorothiazide, a commonly-used diuretic.
Health regulators now believe that, due to a change in manufacturing process, a deadly chemical that can cause cancer has been introduced into much of the world’s valsartan supply. Officials across the world are attempting to gauge the contamination’s possible affect on public health.
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What Is Deadly Contaminant Found In Valsartan?
N-Nitrosodimethylamine (NDMA) is an organic chemical used in a limited range of industrial applications and created as a toxic byproduct of industrial manufacturing practices. It used to be an additive in rocket fuel, the Environmental Protection Agency notes, and can now be found in use as an additive for lubricants and an antioxidants.
It is often used in medical research, where scientists expose rats to NDMA to incite the growth of cancerous tumors for research. Very minute amounts of the substance can also be found in some foods, including cured meats and smoked fish.
Health Risks Of NDMA Exposure
NDMA is very toxic. Both sudden short-term exposure and chronic exposure can cause liver damage in humans, the EPA writes, along with distressing symptoms like nausea, vomiting and headaches. Much of what we know about the effects of NDMA comes from animal studies. In rats, mice and hamsters, the chemical poses a risk of hematological (blood-related) and liver-based side effects, including internal bleeding and widespread tissue death. Chronic exposure to NDMA has been linked to severe liver damage in animals.
In animal studies, NDMA has been linked to a range of cancerous tumors, including liver, kidney and lung cancers. Rats and mice who inhaled the chemical have been shown to suffer an increased incidence in lung, kidney and liver tumors. Liver tumors are increased in mice, rats and kidneys exposed to NDMA through oral administration.
Based on the results of these studies, the Environmental Protection Agency has classified NDMA as a Group B2 probable human carcinogen. It is likely that exposure to N-nitrosodimethylamine causes cancer in humans.
The findings have led to a worldwide recall effort. Zhejiang Huahai Pharmaceuticals and Hetero Labs Limited supply valsartan to many of the globe’s largest generic drug manufacturers.
Zhejiang Huahai-Supplied Tablets
According to the US Food & Drug Administration, the following US pharmaceutical manufacturers have agreed to issue voluntary recalls for their valsartan-containing medications:
- Major Pharmaceuticals (valsartan)
- Solco Healthcare (valsartan; valsartan and hydrochlorothiazide)
- Teva Pharmaceutical Industries Ltd. (valsartan; valsartan and hydrochlorothiazide)
These products all included valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company based in Linhai, China. Authorities believe that, around 2012, Zhejiang Huahai altered its manufacturing process for valsartan. This change in manufacturing process introduced NDMA contamination into the product.
Hetero Labs / Camber-Supplied Tablets
The first FDA recall was soon followed by a second. On August 9, 2018, the FDA expanded its prior recall to include a range of valsartan products that contained valsartan manufactured by Hetero Labs Limited, an Indian company that uses a similar manufacturing process to Zhejiang Huahai. Products manufactured by Hetero Labs Limited may be labeled as Camber Pharmaceuticals Inc.
As the FDA wrote, “Camber Pharmaceuticals is recalling certain valsartan tablets because they contain the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient.” The agency continued: “test results from Hetero Labs show the amount of NDMA found in its valsartan [active pharmaceutical ingredient] exceeds acceptable levels; although it is generally lower than the amount discovered in the [active pharmaceutical ingredient] manufactured by Zhejiang.”
Included in the expanded recall are valsartan tablets 8 new US manufacturers:
- A-S Medical Solutions LLC
- Bryant Ranch Prepack Inc
- HJ Harkins Company
- Northwind Pharmaceuticals
- NuCare Pharmaceuticals Inc.
- Proficient Rx LP
- Remedy Repack
Patients have been instructed to check their medication bottles for the company name and company label. If you are currently taking a recalled medication, do not stop taking it because of the recall. Call your doctor as soon as possible; there are uncontaminated versions of valsartan that you can switch to, along with additional treatment options to discuss.
European Regulators Issue Wide-Ranging Recall
The FDA’s strong actions come on the heels of a similar initiative in Europe. On May 7, 2018, the European Medicines Agency (EMA) announced its own wide-ranging recall of valsartan products. The EMA issued a mandatory recall for 2,300 batches of valsartan-containing medications that had received their supply of the drug from Zhejiang Huahai, affecting a total of 22 countries:
- the Netherlands
- Bosnia and Herzegovina
The EMA says that Zhejiang Huahai “detected an impurity, N-nitrosodimethalyamine, in the valsartan active substance which the company supplies to manufacturers.” The company came forward, reported its concerns to the European Medicines Agency and triggered the agency’s review of the product. The review is still ongoing. Officials at the EMA tell us that they are continuing to investigate “the levels of NDMA” in the valsartan medicines and the impact that the impurity could pose to patient health.
Pharmacies in the United Kingdom have been told to recall batches of valsartan tablets manufactured by Dexcel Pharma Ltd. and Accord Healthcare.