The Food and Drug Administration claims that its metformin testing has not found unacceptable levels of the carcinogen NDMA. However, a testing laboratory called Valisure has reported findings that are challenging the FDA’s results via a “Citizen Petition.”
Forty-two percent of the metformin batches tested by the independent lab showed much higher levels of cancer-causing NDMA than the FDA’s allowance for daily intake. Of the 38 batches of metformin tested, coming from 22 different companies, Valisure found 16 batches with excessive NDMA. These 16 batches were from 11 separate manufacturers, indicating something serious is happening to the popular diabetes medication somewhere along the manufacturing chain. In several of these tainted batches, there were levels of NDMA at least 10 times greater than the safe, allowable amount.
Equally as concerning, Valisure found “significant variability from batch to batch, even within a single company.” The lab’s petition points out that these variations within the same company’s individual batches prove that some drugs, including metformin, should be tested at the batch level before being released to the public. Valisure enlisted Emery Pharma, another testing lab, to check Valisure’s findings, and Emery Pharma found similar results. Valisure wants the FDA to immediately recall the carcinogenic batches of metformin.
“This certainly underscores the prevalence of existing pharma quality problems, which may end up becoming even worse as coronavirus continues to derail Chinese drug manufacturing, where the majority of U.S. drugs originate from,” said Valisure CEO David Light in an email. “Many of these existing safety and quality issues, like the ones we identified in metformin, likely stem from overseas manufacturers cutting corners. It is certainly possible that many more corners may be cut in the scramble to ramp up production and fill backorders.”
In February, the FDA announced it had tested “some metformin” products and determined that the NDMA levels in metformin fell between the “not detectable” range and the “low levels” range. Further, the FDA reported that none of the samples had an NDMA level in excess of the agency’s acceptable daily intake amount. “FDA has not recommended metformin recalls in the U.S.,” is the agency’s conclusion. In an email, the FDA said, “We will respond directly to the petitioners.”
Valisure has already filed two previous petitions in which the lab called for the government agency to pull all Zantac and the generic ranitidine off the shelves after the company discovered carcinogenic impurities in batches it tested. In a filed petition, Valisure also requested that the FDA create a standard for a particular solvent that is used in manufacturing some drugs. The lab believes the solvent’s use is contributing to the increased levels of NDMA as well as other impurities that have shown up in this country’s drug supply.
In 2018, similar impurities began appearing in the “sartan” group of blood pressure medications. When this occurred, a global recall began. Hundreds of lots of losartan, irbesartan, and valsartan blood pressure drugs were removed from the purchasing chain. The FDA’s resultant intensive investigation led the agency to send warnings to some manufacturers. Following this upheaval, the FDA started testing some other medications that could possibly have similar issues.
Valisure believes “contamination in these batches of metformin appears to be similar to the issues that continue to plague blood pressure medications like valsartan and losartan.” Further, “Valisure urges FDA and industry to take swift and broad action to clean up the U.S. supply of metformin, a drug that tens of millions of Americans rely on.”
The lab sees that self-testing by manufacturers is obviously not working, and it suggests that mandatory testing by a third party be implemented. Of course, such a move could obviously benefit Valisure.
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- Eric Palmer. “Testing lab challenges FDA findings that carcinogens in metformin do not exceed acceptable levels”, Fierece Pharma, https://www.fiercepharma.com/manufacturing/testing-lab-challenges-fda-findings-carcinogens-metformin-do-not-exceed-acceptable. Accessed March 30, 2020.