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April 05, 2019

FDA releases list of nitrosamine-free blood pressure medications amid shortage

Agency: Importance of treatment 'far outweighs' concern over ARB contamination in short term

Adult Health Blood Pressure
Doctor takes a patient's blood pressure rawpixel/

Whether hypertension is an issue that affects you or not, you’re likely aware of the blood pressure medications recalled in recent months because of contamination with potentially carcinogenic impurities. 

Americans now face a shortage of medicines in a category of drugs known as angiotensin II receptor blockers, or ARBs. These drugs lower blood pressure by blocking angiotensin, a protein hormone, which constricts blood vessels, Web MD explains.

Despite the concern that many ARBs are contaminated with nitrosamines, an environmental contaminant found in food and water, the FDA is telling patients that the need to prevent stroke and other health issues “far outweighs the low risk" of developing cancer by taking the medications for a short time, "until the patient’s doctor or pharmacist provides a safe replacement or a different treatment option."

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The agency is suggesting patients make do with these potentially harmful medications until a fresh supply of uncontaminated ARBs will be available, which the agency estimated to be in an about six months, according to the FDA’s statement from Commissioner Scott Gottlieb and Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research. 

Further, the FDA released a list of 40 blood pressure medicines it has deemed via testing to lack nitrosamines. The agency has outlined these ARBs in its report, “FDA’s Assessment of Currently Marketed ARB Drug Products.” 

“Despite the very low risks associated with the use of affected ARBs, we fully recognize that these medications can be made without nitrosamine impurities and are working with manufacturers to reach that goal,” Gottlieb and Woodcock said in their statement. “We’ll continue to improve our science and standards for detecting and preventing the development of genotoxic impurities during the drug manufacturing process, and this will remain an area of intense focus in the months ahead."

Health Day adds the first step patients should take in light of the ARB safety concerns is to consult with their physician about an alternative medication.

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