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A generalized reminder of common medications for blood pressure and heart failure has been expanded to include more drugs containing losartan. The recall is due to an "impurity" classified as a potentially carcinogenic substance for humans.
The impurity, N-nitroso-N-methyl-4-aminobutyric acid or NMBA, is also classified as a carcinogen to animals, the US Food and Drug Administration announced in a press release published on Friday.
Camber Pharmaceuticals Inc. voluntarily recalled 87 lots of losartan tablets to the United States on Thursday. The recalled tablets manufactured by Hetero Labs Ltd. In India and distributed by Camber Pharmaceuticals, have been found to contain traces of impurity.
The recall indicated that Camber has not received any reports of adverse events related to the recall.
The recall is the latest in an ongoing investigation into a class of drugs known as angiotensin receptor blockers or ARBs, which contain valsartan, losartan or irbesartan and are used in patients with high blood pressure and other conditions.
Since July, separate batches of drugs for blood pressure and heart failure in ARAs have been recalled worldwide, including in the United States, due to the presence of impurities similar substances that may be carcinogenic to humans: N-nitrosodimethylamine or NDMA and N-nitrosodiethylamine or NDEA.
Recent reviews of NDMA and NDEA by the FDA in the recalled drugs revealed that "overall, the risk for each patient is very low," but the agency added that these findings do not decrease importance of this problem and continues to assess the risks faced by patients.
At present, the FDA is "deeply concerned" by the presence of a third impurity in some BRA-based medications, Commissioner Scott Gottlieb said in a press release. NMBA has not been found in previously recalled ARB products, but the FDA is continuing its investigations.
"It is important to note that, according to the FDA's initial assessment, the increased risk of cancer in NMBA-exposed patients appears to be the same for NDMA exposure, but less than the risk associated with exposure to NMMA. NDEA. That said, the presence of such impurities in the drugs is not acceptable. In recent months, the FDA has conducted an extensive investigation and collaborated with drug manufacturers to combat the presence of impurities in these products, "said Gottlieb.
"Our ongoing efforts have determined that impurities can be generated by specific chemical reactions during the manufacturing process of the drug's active pharmaceutical ingredients. FDA scientists have developed innovative and sophisticated test methods specifically designed to detect and measure the impurities of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) in ARB-containing drugs. . Due to the discovery potential of other nitrosamine impurities, we conduct a thorough analysis of organic chemistry in order to develop new test methods for detecting other impurities of nitrosamine, including NMBA ", did he declare.
"We continue to share these testing methods with international regulators, the private sector and the general public to help manufacturers and other regulators evaluate these products for potential nitrosamine impurities."
The FDA has put in place protective mechanisms against drug contamination, said this week Maisha Kelly Freeman, professor and director of the Center for Innovation in Health and Results Research for Patients' Samford University.
Manufacturers are obliged to report impurities, for example, and the agency inspects factories according to the risks. However, there is a problem.
"Of course, if they do not look for it, they do not really know it's happening," Freeman said. And that's what happened with contaminated ARAs.
"Before discovering this compound, they did not even know that a chemical reaction could produce the compound," she said.
Regarding the impact of the recall on patients and pharmacists, "most patients need to get their medications replaced" by many drugs that have not been affected, Freeman said. Other people see their prescriptions changed.
From the point of view of community pharmacies, this recall was difficult because many pharmacies do not keep the number of batches of drugs after dispensing, said Freeman: "This information is not followed effectively."
She hopes that in the coming years, technologies such as barcodes will be in place to help identify affected patients.
Regarding the last recall, the FDA reminded patients that a recalled drug had been prescribed an ARA medication to continue taking their medication until their doctor or pharmacist offers a replacement product or offers them a different treatment. Patients are also encouraged to consult their doctor or pharmacist as soon as possible.
According to the FDA, "Not all ARB products contain NDMA, NDEA or NMBA impurities, so pharmacists may be able to provide alternative medication unaffected by the boosters, or that health professionals may prescribe a different medication treating the same problem. "
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