FDA is analyzing different drugs to check the presence of nitrosamine impurities. During the last eighteen months, nitrosamine impurities like N-Nitrosodimethylamine (NDMA) has been found in small quantities in different drugs such as Zantac and angiotensin II receptor blockers (ARBs).
The FDA’s work will ensure that the drugs utilized by the U.S. population are meeting the standard quality requirements. FDA is well informed that countries other than the U.S. have reported small amounts of NDMA in diabetes drugs like metformin.
However, according to the available information, the FDA observed that NDMA levels present in these drugs are almost the same as found naturally in water and some foods. Though some regulatory agencies in these countries have recalled some diabetes drugs, none of such recalls have been made in the U.S. market.
Right now, the FDA is investigating whether nitrosamine impurities are present in the metformin available in the U.S. market and if its amount exceeds 96 nanograms (acceptable daily intake limit).
The Food and Drug Administration will work together with different companies for testing various samples of metformin that are sold within the U.S. Also, the agency will take the appropriate measurements (such as a recall) if the test results indicate high levels of impurities in a sample.
If metformin recall is made as a part of the investigation, the agency will timely inform healthcare providers and patients regarding this matter. Metformin is a drug prescribed to diabetes type 2 patients for controlling their blood sugar levels. Discontinuing the drug intake without consulting healthcare providers can worsen the health.
According to the FDA, there is no need to discontinue the use of metformin, as the agency is still investigating this matter and no other drug can manage the blood sugar levels in the same way as metformin. Almost every individual is exposed to NDMA as it’s common water and food contaminant.
According to the international scientific community and FDA, nitrosamine ingestion at low levels doesn’t harm the individuals. Daily NDMA exposure at-or-below 96 nanograms for 70 years isn’t anticipated to increase the risk of cancer. But its chronic exposure or intake above the acceptable daily limit can increase the cancer risk.
With the knowledge about various conditions or manufacturing processes that may lead to NDMA formation and better techniques to test ita presence, even trace amounts of the impurities can be detected in drugs like metformin.
The FDA will continue its investigation on finding how impurities enter these drugs. Several reasons may contribute to the presence of nitrosamine in drugs. Previous investigation has found that the chemical structure and manufacturing process of the drug, and even its packaging or storage conditions may act as a source of nitrosamine in drugs.
Moreover, nitrosamines such as NDMA may also be formed when drugs and foods are processed in an individual’s body. These investigations are time taking and include factors like the number of Americans using these drugs, the drug’s clinical necessity, and the availability of alternative treatment options.
FDA knows such problems affect the well-being and the health of the patients in many ways. And its objective is to clarify such issues and facilitate healthcare professionals and patients in making healthcare decisions.
After the scientific confirmation, the agency will share the information to provide answers to the public as much and as soon as possible.