The announcement follows months of investigating impurities found in ARBs.
Officials with the FDA have identified 40 angiotensin II receptor blockers (ARBs) that do not contain any known nitrosamine impurities. The announcement follows months of investigating impurities found in ARBs.
“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, MD, and Janet Woodcock, MD, director of the Center for Drug Evaluation and Research, in a joint prepared statement. “We’ll continue to update this list of nitrosamine-free ARBs as we become aware of additional information and as we progress in our assessments of other ARB medications."
A full list can be found on the agency’s website. In addition to the 40 medications listed as not containing impurities, the website includes other products on the market that remain under evaluation.
Multiple recalls involving ARBs containing impurities have been announced since July 2018. Many of these affected products contain valsartan, losartan and irbesartan, and indicated for treating hypertension, heart failure, or renal disease.
In their statement Gottlieb and Woodcock said the FDA is continuing to work with manufacturers to swiftly remove medications from the market if they contain a nitrosamine impurity at levels higher than the interim acceptable intake limits. Removing the affected medications, such as valsartan, from the market has led to shortages, and the agency has been working to mitigate and prevent shortages as often as possible, they said.
“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. After careful evaluation of safety data and consideration of the benefits and risks to patients, we think it’s critical that patients have access to these drugs while impurity-free losartan is manufactured,” the FDA officials said. “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 agency expects many companies will be able to manufacture losartan without nitrosamine impurities and replenish the U.S. supply in approximately 6 months.”
In March, the FDA approved a generic valsartan in another effort to help relieve the shortage of that drug.
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, FDA officials said. 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. The agency is closely monitoring the supply of ARBs and will communicate any drug shortages promptly to the public. Today’s news, of the certainty and broad number of nitrosamine-free ARB medicines, is another positive step. Health care practitioners should familiarize themselves with alternative medicines that can be used in case of shortages.
Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue [news release]. Silver Spring, MD; April 4, 2019: FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635251.htm. Accessed April 4, 2019.