The U.S. Food and Drug Administration (FDA) is placing more scrutiny on medications due to cancer-causing contaminants.
Nitrosamine is a type of chemical found in some food items and tobacco. This chemical is known to cause cancer in lab test animal subjects and can increase the risk of some types of cancers in people.
The FDA reported in 2020 that the chemical increases the risk of cancer in people if they are exposed to above-acceptable levels over long periods of time.
Lupin Pharmaceuticals Inc. initiated a recall for a blood pressure medication known as Quinapril after discovering a nitrosamine impurity in testing, as previously reported by The Dallas Express.
The FDA has instructed drug manufacturers to evaluate their products and assess the risk that those products could contain nitrosamines. Companies are required to address any issues by October, according to USA Today.
Dr. Stephen Hecht, a University of Minnesota professor of cancer prevention, told USA Today that the nation has undertaken initiatives to remove risks associated with food items.
“The difference is with drugs it’s totally avoidable,” said Hecht, according to USA Today.
Despite the fact that this chemical can present a danger, the FDA has maintained that the risk associated with it is low. In the case of the Quinapril tablets, patients were still advised to continue to take the medication.
“The key message is it’s a small risk; there’s no imminent danger,” said Dr. Yul Ejnes, chair of the American Board of Internal Medicine, according to USA Today. “There’s no need to stop the drug. Now, we can find replacements,” he continued.
The FDA similarly called for Zantac, a heartburn drug, to be removed from shelves in 2020 due to its nitrosamine levels.
David Light, CEO and co-founder of Valisure, an independent lab that discovered Zantac impurities in 2019, said that despite FDA regulations in place, it is up to manufacturers to honor those standards, telling USA Today, “some manufacturers are going to do a better job than others.”