Recalled blood pressure drugs not linked to increased short term cancer risk

September 12, 2018, British Medical Journal
Credit: CC0 Public Domain

Products containing the withdrawn blood pressure drug valsartan are not associated with a markedly increased short term risk of cancer, finds an expedited analysis published by The BMJ today.

The findings provide reassuring interim evidence about the risk of cancer in patients treated with valsartan products, but the authors say further studies are required to evaluate the risks for single cancers as well as longer term effects.

In July 2018, some valsartan products manufactured by the Chinese company Zhejiang Huahai Pharmaceuticals were suspected of having been contaminated with N-nitrosodimethylamine (NDMA), an impurity that can cause cancer.

Following the discovery, both European medical agencies and the US Food and Drug Administration (FDA) withdrew affected valsartan products from the market.

To better understand the possible consequences and help inform regulatory bodies about this potential public issue, the Danish Medicines Agency collaborated with the University of Southern Denmark to assess the association between use of potentially NDMA contaminated valsartan products and risk of cancer.

Using data from Danish health registries, they included 5,150 patients aged 40 years and over with no previous cancer who used products containing valsartan between 1 January 2012 and 30 June 2018.

Based on product analysis and dose used, patients were classified as being exposed or not exposed to NDMA and were followed from one year after entering the study, for a median of 4.6 years, during which time cases of cancer were recorded.

After taking account of age, sex, and other potentially influential factors, the researchers found that, overall, exposure to potentially NDMA contaminated valsartan products showed no association with cancer compared with exposure to valsartan products that were not contaminated with NDMA. There was also no evidence of a dose-response pattern.

However, when they analysed single cancers, they found a slightly increased (but not statistically significant) risk of colorectal cancer and uterine cancer in patients exposed to NDMA. While they cannot fully explain this, it might require further study.

More importantly, the limited follow-up means that assessment of long-term effects is not possible, and the low number of events makes interpretation of estimates for single cancer outcomes difficult.

Nevertheless, the researchers believe that their results can support regulators in their evaluation of the potential public health impact of NDMA exposure via valsartan drugs—and provide some reassurance for people who might have been exposed.

They conclude: "Our results do not imply a marked increased short term overall cancer risk in users of valsartan contaminated with NDMA. However, uncertainty persists regarding single cancer outcomes, and studies with longer follow-up are needed to assess long-term risk."

In a linked editorial, Rita Banzi and Vittorio Bertele' at the Center for Drug Regulatory Policies in Milan, Italy, say "this study alone cannot dispel doubts about the potential risk for patients in the longer term, but it helps inform decision-making around this episode."

"It also illustrates the usefulness of national registries for examining the relations between risk factors and health problems and how research can give a prompt response whenever public health concerns emerge," they add.

Regulatory actions coupled with the generation of robust evidence, they say "are the keys to responding promptly to emerging public health concerns."

Explore further: Chinese firm recalls heart drug as US, EU raise concerns

More information: Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study, www.bmj.com/content/362/bmj.k3851

Editorial: Regulatory response to contaminated valsartan, www.bmj.com/content/362/bmj.k3855

Related Stories

Chinese firm recalls heart drug as US, EU raise concerns

July 18, 2018
The Chinese manufacturer of a widely used blood pressure medication said it had launched a global recall after US and European regulators warned of contamination by a cancer-causing impurity.

FDA recalls heart medication valsartan, citing cancer concerns

July 17, 2018
The U.S. Food and Drug Administration issued a voluntary recall of several medications that contain the active ingredient valsartan, which is used to treat high blood pressure and heart failure.

European regulator launches review of recalled heart drug

August 2, 2018
The European Medicines Agency (EMA) said Thursday it is conducting a review of the health effects on patients of a widely used blood pressure medication recalled around the world last month.

Affected by the valsartan heart drug recall? here's what to do

July 19, 2018
(HealthDay)—After the U.S. Food and Drug Administration announced last week that certain brands of blood pressure medicines contained a carcinogen and were being recalled, many patients may wonder what's next for their ...

More problems found in Chinese-made heart medications

August 6, 2018
Two more Chinese drugmakers have announced that a blood-pressure medication they exported to Taiwan contained a potentially cancer-causing impurity, a month after the same problem at another Chinese manufacturer prompted ...

Valsartan cuts microalbuminuria in impaired glucose tolerance

February 9, 2017
(HealthDay)—For patients with impaired glucose tolerance (IGT), valsartan is associated with reduced incidence of microalbuminuria, according to a study published online Jan. 17 in Diabetes, Obesity and Metabolism.

Recommended for you

Drug overdose epidemic goes far beyond opioids, requires new policies

November 7, 2018
Most government-funded initiatives to address the overdose epidemic in the United States have targeted opioids specifically and have neglected other drugs that are increasingly implicated in overdoses, such as cocaine and ...

Zebrafish larvae help in search for appetite suppressants

November 2, 2018
Researchers at the University of Zurich and Harvard University have developed a new strategy in the search for psychoactive drugs. By analyzing the behavior of larval zebrafish, they can filter out substances with unwanted ...

FDA OKs powerful opioid pill as alternative to IV painkiller

November 2, 2018
U.S. regulators on Friday approved a fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals.

Amphetamine-related hospitalizations surged between 2003 and 2015

November 2, 2018
An analysis conducted by Hennepin Healthcare, University of Minnesota School of Public Health and University of Michigan researchers shows amphetamine-related hospitalizations increased more than 270 percent from 2008 to ...

Cocaine-fentanyl overdoses underscore need for more 'test strips' and rapid response

November 1, 2018
Penn Medicine emergency department physicians are calling for more readily available testing strips to identify the presence of fentanyl in patients experiencing a drug overdose, and a rapid, coordinated response among health ...

Combination drug targeting opioid system may help relieve symptoms of major depression

October 29, 2018
Two clinical trials of an investigational drug that targets the opioid system support its safety and effectiveness in reducing symptoms of major depression, when added to standard antidepressant treatment. The results of ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.