ANOTHER batch of blood pressure drugs recalled over traces of cancer-causing chemical used in ROCKET FUEL
- Last summer, it emerged valsartan produced in China was contaminated with a carcinogen called NDEA, prompting a global recall
- Months later, drugs are still being recalled for the same reason
- Earlier this month, European regulators recalled Irbesartan over NDEA fears
- On Monday, a US company followed suit
- More than two-thirds of all active drug ingredients originate in China and India
Mia De Graaf Health Editor For Dailymail.com
A US company has recalled blood pressure drugs over fears they contain a carcinogen used in rocket fuel – three weeks after European regulators pulled the same drug for the exact same reason.
Irbesartan is the latest of many China- and India-made drugs being pulled from US and EU markets in recent months after inspectors became aware of contamination issues in top manufacturing plants.
The primary concern is the presence of a carcinogen called NDEA
On Monday, Prinston Pharmaceutical Inc announced it was pulled one lot of Irbesartan and seven lots of Irbesartan HCTZ tablets after detecting higher levels of NDEA than the FDA permits.
In summer 2018, it emerged valsartan produced in China was contaminated with a carcinogen called NDEA, prompting a global recall. Months later, more drugs are still being recalled
The blood pressure recall saga started last summer when it emerged that China-made valsartan – originally developed by Novartis but now off patent – had been contaminated with NDEA, prompting a global recall.
In October, the FDA started taking action, halting imports of drug ingredients or medicines containing ingredients produced at Zhejiang Huahai Pharmaceuticals, a Chinese factory which bulk manufactures valsartan.
That prompted Mylan NV to announced that it would recall all lots of its blood pressure medicines containing valsartan.
As the ordeal dragged on, attention became laser-focused on China’s drug-making.
Then, on January 3, US regulators revealed the issue was bigger than previously thought: an Indian generic drugmaker, Aurobindo Pharma Ltd, would be recalling 80 lots of medicines containing the blood pressure drug for the same reason.
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The latest piece of the puzzle is the US recall of Irbesartan, used by millions of Americans for hypertension.
On Monday, Prinston Pharmaceutical Inc said they had not received reports of illness or reactions but the global situation drove them to pull the drug.
‘Patients who are on Irbesartan should continue taking their medication until their pharmacist provides a replacement, or their doctor prescribes a different medication that treats the same condition as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative,’ they said in a press release.
Experts say this one case is unlocking a Pandora’s Box of imperfections and flaws in the way we manufacture, distribute and screen drugs.
Guido Rasi, the European Medicines Agency’s Executive Director, said: ‘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.’
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