The U.S. Food and Drug Administration cautioned patients that the added risk of cancer from taking valsartan medications that have been the subject of recent global recalls does not outweigh the risk of ceasing to take the high blood pressure and heart medications.
In an Aug. 28 statement, the FDA addressed concerns that have been raised by patients in light of global recalls and regulatory scrutiny of valsartan medications, which began in 2018. Companies such as Teva Pharmaceutical Industries Ltd. and Torrent Pharmaceuticals Ltd. pulled affected products from the market after cancer-causing impurities were found in pills manufactured in China.
The impurity, known as N-nitrosodimethylamine, or NDMA, is a known carcinogen in Europe, although no conclusive evidence links the substance to causing cancer in humans.
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said the actual risk to patients from taking any of the multiple generic forms of valsartan and other related drugs, called angiotensin II receptor blockers, or ARBs, is likely much lower than estimates, which were based on the highest possible exposure.
The U.S. regulator estimated that if 8,000 people took the highest valsartan dose containing NDMA for four years, only one additional cancer case will occur over the lifetime of the group. Moreover, a patient taking an ARB for four years is unlikely to have consistently received one of the affected products.
The risk of stopping the intake of an ARB product for treating high blood pressure and heart failure greatly outweighs the potential risk of exposure to trace amounts of the impurity, Woodcock said.
Exactly how many patients are impacted by the recalls is unknown. Patient prescription bottles do not have lot numbers on them, and therefore, identifying pills that were part of the recall was difficult for patients and pharmacists. But the FDA said many patients and doctors may have returned or replaced prescriptions out of an abundance of caution, meaning more people were affected by the recall than the impurity itself.
Since July 2018, the FDA has issued a number of recalls for affected lots of ARBs, which are used to treat high blood pressure and other cardiovascular conditions. The recalled products also include medicines manufactured by generics drugmakers Mylan NV, Prinston Pharmaceutical Inc. and others.
Officials at the regulatory agency traced the cancer-causing impurities to pharmaceutical ingredient makers in China and India, including Zhejiang Huahai Pharmaceutical Co. Ltd. and Lantech Pharmaceuticals Ltd. The FDA has banned the U.S. import of active pharmaceutical ingredients manufactured by the two companies.
The regulatory body conducted an inspection of Lantech in March that showed the solvent recovered by the company contained a different impurity, N-Nitrosodiethylamine. The FDA issued a warning letter to the Indian company for current good manufacturing practice violations in June.
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