A Chinese pharmaceutical company has announced a recall of blood pressure medicines containing valsartan from the US market after an impurity was found. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured. Also, the FDA said there is a link between valsartan and cancer. If you are unable to find that information on the label, contact the pharmacy where you purchased your medication.
Huahai has said it is unable to determine how much it will lose from the recall, but its own data shows that sales of valsartan, which is mostly sold to North America, Europe, India, Russia and South America, totaled CNY328 million (USD49 million) a year ago, compared with total revenue of CNY5 billion (USD749 million). "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. Pharmacies in the United Kingdom are advised to recall valsartan batches containing medicines made by Dexcel Pharma Ltd and Accord Healthcare.
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Patients should also contact their healthcare professional such as the pharmacist who dispensed the medication or doctor who prescribed the medication if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.
This recall is being conducted with the full knowledge of the U.S. FDA.
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"When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we're committed to taking swift action to alert the public and help facilitate the removal of the products from the market", said Commissioner Dr. Scott Gottlieb. "This is why we've asked these companies to take immediate action to protect patients".
The FDA will continue its investigation into the drug.
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"It's not just valsartan", said Lever.