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Health officials recall 260,000 packs of blood pressure pills because they "may contain a carcinogenic chemical"
- Losartan, a commonly prescribed antihypertensive drug, has been recalled
- The Drug Regulatory Agency and Health Products announced today
- The pills may have been contaminated with a chemical found in cigarette smoke
By Sam Blanchard Health Journalist for Mailonline
published: 14:09 EDT, March 21, 2019 | Update: 2:28 pm EDT, March 21, 2019
More than a quarter of a million packets of hypertension medications have been recalled in the UK.
The government agency, the Regulatory Agency for Medicines and Health Products, today issued a warning about losartan pills manufactured by the company Accord.
This is the latest in a range of recalls of sartan-type drugs, which may have been exposed to carcinogenic chemicals in factories in China and India.
This is now the fourth reminder of the MHRA in 2019 – patients are urged not to stop taking their medications except on the advice of their doctor or pharmacist.
The British government has recalled packets of 28 losartan tablets manufactured by the company Accord, fearing that they contain a carcinogenic chemical.
The recall concerns Losartan potbadium film-coated tablets, containing 50 mg and 100 mg, packaged in packs of 28.
The expiry dates of the packages are June 2019, November 2019 and August 2020.
A total of 264,797 packs are included in the batches, representing a possible total of 7.4 million tablets.
Other similar drugs, including irbesartan and valsartan, have been recalled in the last year due to concerns about the penetration of hazardous chemicals.
These losartan pills have been named because they may contain NMBA chemical, full name of N-Nitroso-N-methyl-4-aminobutyric acid.
NMBA, a carcinogen and present in cigarette smoke, was first discovered as a contaminant at the beginning of the month.
The US Food and Drug Administration has found traces of this product in losartan pills manufactured by Hetero Labs Ltd in India.
Other drugs have been implicated due to concerns regarding different chemicals, namely NDMA and NDEA, both substances believed to increase the risk of cancer.
But the MHRA said the recall was "a precautionary measure" and that there was no evidence that the contamination actually hurt patients.
"Our priority as a regulator is to make sure that the medications you take with your family are effective and of an acceptable level of safety," said Bernadette Sinclair-Jenkins, spokesperson for the MHRA.
"This reminder shows that we continue to study the possibility of contamination with drugs containing sartan.
"There is currently no evidence that drugs containing NDMA, NDEA or NMBA have caused harm to patients, and this recall is a precautionary measure.
"Because of the risk of stopping antihypertensive therapy suddenly, continue taking your medications as prescribed by your doctor.
"Please talk to your doctor or pharmacist if you have any concerns about your medicine."
Chronology of recent anti-TB drug recalls
2012 – It is thought that valsartan, a medicine for hypertension, has already been contaminated by the carcinogenic chemical NDMA, a rocket fuel, as early as 2012.
European regulators warned last year that the main drug manufacturer in China – Zhejiang Huahai Pharmaceutical – had changed its manufacturing process seven years ago, which may have been to blame.
July 5, 2018 – The UK has reminded the drug of growing concern.
Many European authorities then followed suit.
The European Medicines Agency said it was working to determine how long and at what level patients might have been exposed to NDMA.
July 17th – The US Food and Drug Administration has ordered the ban on the prescription of valsartan.
July 30 – The China National Health and Family Planning Commission has stated that the drug should not be used for diagnosis or treatment.
January 3, 2019 – The Medicines and Health Products Regulatory Agency (MHRA) has recalled thousands of drugs containing irbesartan, a drug for high blood pressure, for fear of NDEA.
The government-run body has issued an alert on four batches of medication and has removed the products – manufactured by Actavis, now known as the Accord – as a "precautionary measure."
January 23, 2019 – Prinston Pharmaceutical Inc., an American drug company, has announced that it voluntarily recalled irbesartan and irbesartan HCTZ after finding higher NDEA levels than those authorized by the Food and Drug Administration.
January 24, 2019 – The UK's MHRA recalled 3 other batches of irbesartan, this time concerning film-coated 150 mg and 300 mg tablets supplied by Macleods Pharma UK.
March 12, 2019 – The US Food and Drug Administration has been quick to try to approve new generic versions of valsartan as the shortage is causing contamination issues with recalls.
March 21, 2019 – The MHRA recalls three batches of losartan, a medicine for high blood pressure, fearing it's getting contaminated with a chemical called NMBA, which has only surfaced this month in a factory in India.
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