For the fourth time this year, another drugmaker has recalled some of its products because of nitrosamines, which have been linked to cancer in animal trials.
On Oct. 25, Aurobindo Pharma recalled two lots of its blood pressure drug because of the presence of nitrosamines, which "may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time," according to the FDA.
No adverse effects have been reported to the agency regarding Aurobindo's recall.
In spring, Pfizer recalled some lots of its blood pressure drugs and Sandoz recalled 13 lots of its pain medication because of the carcinogen. Then in August, the FDA warned that samples from some of Merck's Type 2 diabetes drugs contained nitrosamines.
The FDA first reported a nitrosamine-prompted recall in late 2020, and since then, drug lots have pulled from the market 12 times because of nitrosamine levels surpassing daily intake limits.
Lawsuits against these drugmakers are climbing, too: Trial judgments over nitrosamines could cost drugmakers up to $45 billion, Bloomberg reported Sept. 6.
"Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains nitrosamines at, or below, the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer," according to the FDA.