Several drugcompanies have recalledmedications containing valsartan, an off-patent ingredient used in generic medications to treat heart failure and high blood pressure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products.
The FDA called NDMA a "probable human carcinogen".
The recalled finished products in the USA include all non-expired generic valsartan sold by Major Pharmaceuticals, Teva and Huahai's US subsidiary, Solco Healthcare, as well as valsartan/hydrochlorothiazide (HCTZ) made by Teva and Solco.
"That is why we've asked these companies to take immediate action to protect patients".
To determine if your specific medication has been recalled, look at the name of the drug and the company name on the prescription bottle label.
Valsartan/Hydrochlorothiazide (HCTZ) from Teva Pharmaceuticals Industries Ltd.
"The FDA is committed to maintaining our gold standard for safety and efficacy".
If a patient's medicine is included in the recall, they should contact their health care professional to discuss their treatment options, which may include another valsartan product not affected by this recall or an alternative option.
"O$3 ur drug shortages team is also working hard to ensure patients' therapeutic needs are met in the United States with an adequate supply of unaffected medications", assured Scott Gottlieb, FDA commissioner. Not all valsartan products, however, have been recalled.
The FDA is warning patients who take valsartan to make sure their medication was not manufactured by the offending company. Solco Healthcare's information is already on the FDA's website, information from Major Pharmaceuticals can be found on its website, and early Monday evening Teva Pharmaceuticals USA released a statement with information about the recall. It can also be unintentionally produced through certain chemical reactions and is a byproduct from some pesticide manufacturing, the making of rubber tires or fish processing.
The FDA continues to review this situation and is investigating possible effects on patients taking these drugs and how companies can reduce or eliminate NDMA in future batches of medication.
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