FDA identifies ARBs without nitrosamine impurities
For the first time since FDA discovered a nitrosamine impurity in angiotensin II receptor blockers (ARBs) last summer, the agency said Thursday it has identified 40 ARBs that do not contain any known nitrosamine impurities. This number is expected to increase.
For the first time since FDA discovered a nitrosamine impurity in angiotensin II receptor blockers (ARBs) last summer, the agency said Thursday it has identified 40 ARBs that do not contain any known nitrosamine impurities. This number is expected to increase. "Our goal is for this information to help health care providers as they consider acceptable treatment options for their patients," said FDA Commissioner Scott Gottlieb and Janet Woodcock, director of the Center for Drug Evaluation and Research. "Our assessment takes into consideration testing for impurities conducted by the FDA's laboratories, an evaluation of the manufacturing process used by multiple manufacturers of the active pharmaceutical ingredient (API) found in ARB medicines, as well as other information available to the agency from manufacturers and international regulators." The officials said they are working with manufacturers to quickly remove from the market any products found to contain a nitrosamine impurity at levels higher than the interim acceptable intake limits. Gottlieb and Woodcock added, "Currently, valsartan products are in shortage, and we know that other types of products have the potential to fall into shortage soon. In anticipation, the agency is not objecting to temporary distribution of specific lots of losartan that contain impurities above the interim acceptable intake limit, for a short period of time." They noted they have carefully considered the risks and benefits to patients and evaluated the safety data, concluding that it is "critical that patients have access to these drugs while impurity-free losartan is manufactured. Our scientists feel that this will not have a meaningful increased risk for cancer over the time it should take to get impurity-free losartan to market." The officials stressed that "patients should continue taking their medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option—even if they learn that their ARB medicine is recalled. The risk associated with abruptly discontinuing the use of these important medicines far outweighs the low risk that our scientists estimate to be associated with continuing the medicine until the patient’s doctor or pharmacist provides a safe replacement or a different treatment option."