The Washington Post reported the Food and Drug Administration said that the impurities found in many generic blood pressure drugs over the past several months are a byproduct of the manufacturing process for the drugs’ active ingredients, which was changed several years ago. FDA Commissioner Scott Gottlieb and the director of the FDA’s Center for Drug Evaluation and Research Janet Woodcock said in a statement, “We are making important strides at understanding how these impurities occurred, mitigating the risk to patients and learning what steps need to be taken to prevent this from occurring again in the future. While the total exposure to these impurities for most patients was small, we are deeply concerned that patients were exposed to this impurity in the first place and that the presence of nitrosamines went undetected for a period of time.”
Reuters reported the agency said that the impurities may occur “when specific chemicals and reaction conditions are present in the manufacturing process” and “may also result from the reuse of materials, such as solvents.”
The Wall Street Journal reported the Food and Drug Administration said that two million people may have been exposed to blood pressure drugs manufactured in China and India that were contaminated with the impurities. The agency said that at least half of those patients are in the US.
USA Today reported the blood pressure drugs in question are angiotension II receptor blockers (ARBs), a class that includes irbesartan, losartan, and valsartan. The article added that there have been recalls of all three drugs, because they contained trace amounts of nitrosodimethylamine (NDMA), a carcinogen, or nitrosodiethylamine (NDEA), a probable carcinogen.
The NBC News website reported Gottlieb and Woodcock also said, “Overall, the risk to individual patients remains very small, although this doesn’t diminish the significance of this episode or our concerns.” The FDA also said there is now a shortage of valsartan and that there may be shortages of other ARBs soon due to continuing recalls.
From the news release of the American Association for Justice.
