FDA – September, 2, 2020 – According to a news report on Raps.org, the US Food and Drug Administration (FDA) addressed the issue of nitrosamine contamination in two tuberculosis antibiotic medications, which are critically needed to treat the potentially fatal disease. In a recent report, the FDA clarified how the agency would manage the elevated levels of nitrosamine, a known carcinogen, found in two essential life-saving antibiotics.
Rifampin and rifapentine are antibiotics that are necessary to treat tuberculosis. Rifampin is also given to patients to treat numerous bacterial infections. Recently, high levels of nitrosamines were discovered samples of both medications. Rifampin samples contained high levels of the nitrosamine 1-methyl-4-nitrosopiperazine (MNP). Rifapentine samples contained a different nitrosamine called 1-cyclopentyl-4-nitrosopiperazine (CPNP), and the amount of the CPNP was above the “acceptable intake limit of 0.1 ppm.”
According to the FDA, the medications are so vital to patients with tuberculosis that the FDA is allowing some makers to “temporarily distribute” the drugs rifapentine and rifampin that are known to contain unacceptable levels of nitrosamines until the manufacturers can eliminate or reduce the nitrosamine impurities. The FDA stated that they conducted a risk-benefit analysis, and they determined that these drugs are so important that there cannot be a shortage of availability that would come with a recall or halt in production.
The FDA now requires the makers of rifapentine and rifampin with unacceptable levels nitrosamines to meet with the Center for Drug Evaluation and Research’s Drug Shortage Staff to have their medications reviewed to determine if their drugs could remain in distribution. The FDA and the affected drug manufacturers are conducting an investigation to find the cause of the dangerous impurities found in samples of rifampin and rifapentine. The FDA is also working on a new testing method to help manufacturers and regulators to detect CPNP and MNP in their medications.
Although nitrosamines are substances found in nature, it is well-documented that there is an increased cancer risk when people are exposed to long-term and elevated amounts of nitrosamine. Metformin is a diabetes drug that has been in the news recently due to the discovery of elevated nitrosamine levels. Other medications that have been recalled due to increased nitrosamine levels include antacids with ranitidine, angiotensin-converting enzyme inhibitors, and angiotensin receptor blockers.
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