Pharma recalls its Valsartan drug
UNITED STATES – The drug manufacturer Aurobindo Pharma USA Inc. is recalling a blood pressure medication over potential cancer risks posed by the drug. The medication contains a substance that could be cancerous to patients.
Aurobindo Pharma detected a substance called N-nitrosodiethylamine (NDEA) in numerous lots of its blood pressure drug Valsartan. NDEA is naturally occurring but has been classified as a probable carcinogen by the International Agency for Research on Cancer, according to the U.S. Food and Drug Administration. The substance can be found in water, some foods, and air pollution.
To date, the manufacturer has reportedly not received reports of adverse events related to Valsartan and NDEA, but it is voluntarily recalling 80 lots of the drug. The recall includes the following Valsartan blood pressure medications:
- Amlodipine Valsartan Tablets USP (in doses of 5mg/160mg; 10mg/160mg; 5mg/160mg; and 10mg/320mg)
- Valsartan HCTZ Tablets USP (in doses of 80 mg/12.5mg; 160mg/12.5mg; 320mg/12.5mg; 160mg/25mg; and 320mg/25mg)
- Valsartan Tablets USP (in doses of 320mg)
The FDA has listed on its website all of the lots included in the recall, along with pictures of the labels. These medications are indicated for treatment of high blood pressure and heart failure. Aurobindo Pharma distributed the drugs nationwide and will be notifying all of its distributors about the recall. The recalled lots will be returned to the manufacturer.
Patients who have medications included in the recall should not stop taking their medications but should contact their doctors or pharmacists about an alternate treatment. Aurobindo Pharma states that patients with questions about the recall can contact the corporation by calling (866) 850-2876 and selecting Option 2 or by emailing pvg@aurobindousa.com. Patients can also use these two forms of contact to report adverse events.
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