There has been another recall for blood pressure medications. This time Teva Pharmaceutical has issued a voluntary recall for combination forms of its blood pressure drug Amlodipine due to cancer-causing impurities discovered in the tablets.
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There has been another recall for blood pressure medications. This time Teva Pharmaceutical has issued a voluntary recall for combination forms of its blood pressure drug Amlodipine due to cancer-causing impurities discovered in the tablets.
Teva said the combinations of Amlodipine, which includes Amlodipine/Valsartan combination tablets and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets, were manufactured by Mylan India. The impurity found in the active pharmaceutical ingredient valsartan is N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. While it is classified as a carcinogen, NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution and industrial processes.
Teva’s recall impacts a significant number of drug lots. A full list of the recalled lots can be found here.
As of this morning, Teva said it has not received any reports of adverse events related to exposure to the impurity. Teva said patients who are taking the Amlodipine combination treatments are advised to continue taking their medication, but suggested reach out to the pharmacists who filled the prescription for advice or an alternative treatment. Teva said there is a greater health risk to a patient if they immediately stop treatment for their blood pressure without an alternative backup.
This is not the first time that valsartan has been the subject of a recall due to the presence of NDEA. In July the U.S. Food and Drug Administration issued a voluntary recall of drugs that contained the active ingredient valsartan, In the July recall, an impurity known as N-nitrosodimethylamine (NDMA), another carcinogen, was found in the products.
Teva noted in its recall announcement that the concern over NDEA is not limited to valsartan medicines manufactured and distributed by Teva. Some valsartan-containing products manufactured and distributed by other pharmaceutical companies using the same API supplier may also be affected, Teva said, which suggests that other recalls may be imminent.
Teva’s announcement comes less than a month after the FDA issued a voluntary recall for lots of Irbesartan tablets developed by N.Y.-based ScieGen Pharmaceuticals due to the presence of NDEA. The ScieGen tablets were also manufactured in India, but by Aurobindo Pharma Limited. Those products that were recalled have the names Westminster Pharmaceuticals and Golden State Medical Supply, Inc. on the label, the FDA said.
Valsartan and Irbesartan are both angiotensin II receptor blockers (ARB). The drugs work by blocking a substance in the body known as angiotensin that causes blood vessels to tighten. As a result of its mechanism, ARBs relaxes blood vessels, which lowers blood pressure and increases the supply of blood and oxygen to the heart. After the Irbesartan recall, the FDA reportedly planned to conduct tests on ARBs for impurities such as the carcinogens. The agency had to design a special test after it learned that some ingredients imported from one company in China, Zhejiang Huahai Pharmaceuticals, were tainted, according to the report.
Earlier this month the European Medicines Agency banned valsartan manufactured by Mylan India due to the NDEA impurities.
