Blood pressure pills recalled worldwide amid cancer chemical scare

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British pharmacists were today warned a change in how Valsartan is manufactured has caused a dangerous impurity in several medications


A common blood pressure drug has been recalled worldwide and production has stopped after it was found to contain a cancer-causing chemical.

The drug Valsartan, made in a factory in China, was recalled in 22 countries including the UK and the US earlier in July, but the warning is now worldwide. 

Investigators found a chemical used in rocket fuel, called N-Nitrosodimethylamine, had contaminated the drug’s production at Zhejiang Huahai, a Chinese supplier which ships the medicine worldwide. 

N-Nitrosodimethylamine is thought to be carcinogenic, meaning it could cause cancer in humans, so production of the pills has stopped.

China’s National Health and Family Planning Commission said yesterday that the drug must not be used for diagnosis or treatment, and the pills have already been banned in the UK and US. 

Experts say the contamination could date back as far as 2012, when the company changed its manufacturing process.   

British pharmacists were today warned a change in how Valsartan is manufactured has caused a dangerous impurity in several medications

British pharmacists were today warned a change in how valsartan is manufactured has caused a dangerous impurity in several medications

The US Food and Drug Administration banned Valsartan on July 17, two weeks after the UK recalled the drug, which has been widely prescribed across the world for 15 years.

America’s decision to follow suit came on the heels of a warning from European regulators earlier that day that the drug’s dangers may have been present in batches as far back as 2012.

Valsartan was originally developed by Novartis and the Swiss company marketed it as Diovan, but it is now off patent and is used in a number of generic medicines supplied by various companies. 

In addition to tackling high blood pressure, it is also prescribed to treat heart failure.

The main manufacturer in China is Zhejiang Huahai, which was founded in 1989 and listed on the Shanghai stock exchange in 2003, was one of the first Chinese companies to get drugs approved in the US market.

Company also makes ingredients for HIV and depression drugs 

That same firm makes active ingredients for a number of different medicines to treat heart problems, depression, allergies and HIV, according to its website.

Overall, more than two-thirds of all active drug ingredients originate in China and India, industry experts estimate, with China accounting for the lion’s share. 

The revelation that the problem with Valsartan likely dates back to changes in manufacturing processes at Zhejiang Huahai Pharmaceutical six years ago suggests many patients could potentially have been exposed to cancer risk. 

The European Medicines Agency (EMA), which first raised the alarm over the Chinese supplied Valsartan on July 5, said it was working to establish how long and at what levels patients might have been exposed to the impurity known as NDMA.

Chemical thought to cause cancer in humans 

NDMA, or N-nitrosodimethylamine, is classified as a probable human carcinogen. Based on results from laboratory tests, it may cause cancer with long-term use.

‘It is still too early to provide information on the longer term risk NDMA may have posed for patients. 

‘EMA has made this aspect of the review a priority and will update the public as soon as new information becomes available,’ the agency said.

EU authorities recalled medicines containing Valsartan from Zhejiang Huahai, and the EMA said such medicines should no longer be available in pharmacies.

The U.S. Food and Drug Administration also took action to recall affected valsartan-containing medicines.

Zhejiang Huahai has already acknowledged that there was an impurity in some of its Valsartan, which it said had sales of $50 million in 2017.  

The EMA said NDMA was an unexpected impurity that was not detected by routine tests carried out by Zhejiang Huahai, adding that the manufacturing changes introduced in 2012 were believed to have produced NDMA as a by-product.

EU and US depend on Asia for drugs – but don’t pay enough attention to safety 

The case shows the reliance of consumers around the world on medicines containing active pharmaceutical ingredients made in China.

Regulators have been stepping up oversight of foreign factories in recent years to try and ensure the quality of drugs made in China and India, which is another major supplier to global drug markets.

But it remains a work in progress, as highlighted by the EMA’s Executive Director Guido Rasi, who wrote recently in the agency’s annual report:

‘We need to think globally and work strategically with partners from around the world to make best use of our inspection capacity, so that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured.’

WHAT ARE THE VALSARTAN CONTAINING DRUGS THAT ARE AFFECTED? 
Product nameMarketing Authorisation HolderPL Number
VALSARTAN 40MG CAPSULES, HARDDEXCEL PHARMA LIMITEDPL 14017/0192
VALSARTAN 80MG CAPSULES, HARDDEXCEL PHARMA LIMITEDPL 14017/0193
VALSARTAN 160MG CAPSULES, HARDDEXCEL PHARMA LIMITEDPL 14017/0194
VALSARTAN 40MG FILM-COATED TABLETSACTAVIS GROUP PTC EHFPL 30306/0109
VALSARTAN 80MG FILM-COATED TABLETSACTAVIS GROUP PTC EHFPL 30306/0110
VALSARTAN 160MG FILM-COATED TABLETSACTAVIS GROUP PTC EHFPL 30306/0111
VALSARTAN 320MG FILM-COATED TABLETSACTAVIS GROUP PTC EHFPL 30306/0405

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