Valisure, an online pharmacy currently licensed in 38 states and an analytical laboratory that is ISO 17025 accredited by the International Organization for Standardization (“ISO”) that is dedicated to preventing anyone from suffering adverse effects from low quality medications, announced on March 2, 2020, “Valisure has tested and detected high levels of N-Nitrosodimethylamine (NDMA) in specific lots of the drug metformin, a prescription medication used to control high blood sugar in adults and adolescents with type 2 diabetes … 11 of 22 pharma companies that Valisure tested had batches that exceeded the FDA daily acceptable limit for N-Nitrosodimethylamine (NDMA), a probable human carcinogen.”
“Valisure’s analysis of 22 companies selling metformin and a total of 38 batches revealed 16 batches and 11 companies where NDMA levels were detected above the 96 nanograms (ng) daily acceptable intake limit. Several batches contained over 10 times the daily acceptable intake limit and there was significant variability from batch to batch, even within a single company. These findings underscore the importance of batch-level chemical analysis and the necessity of effective quality surveillance of medications.”
Valisure filed a petition with the FDA on March 2, 2020 in which it represented, in part: “Valisure has tested and detected high levels of N-Nitrosodimethylamine (“NDMA”) in specific batches of prescription drug products containing metformin, a drug used to control high blood sugar in patients with type 2 diabetes. The World Health Organization (“WHO”) and the International Agency for Research on Cancer (“IARC”) have classified NDMA as a Group 2A compound thereby defining it as “probably carcinogenic to humans.” The carcinogenic nature of nitrosamines in general, and NDMA specifically, has been well documented in the scientific community since the 1960s. FDA currently recognizes the danger of this compound and, as a result, has set strict daily acceptable intake limits on NDMA in pharmaceuticals of 96 nanograms (“ng”). Furthermore, the presence of this probable carcinogen in a medication that is taken daily by adults and adolescents for a chronic condition like diabetes, makes this finding particularly troubling.”
“Petitioner urges the Commissioner and FDA to expeditiously request recalls on the affected batches of medication so they are removed from the American drug supply, and to take other such actions outlined in this Petition as deemed appropriate.”
“Petitioner urges FDA to revise their guidance to industry for the analysis of NDMA in metformin to include methods such as those utilized by Valisure that achieve lower LOD [limit of detection], lower LOQ [limit of quantitation], and a wider reportable range, and are less at risk of underestimating NDMA levels. It is of particularly high importance to precisely quantify NDMA in a drug like metformin, given that tablets are often taken four times a day, yielding an acceptable amount of NDMA per tablet of only 24ng (96ng daily intake limit divided by four tablets per day).”
“Valisure’s data clearly shows that NDMA contamination above FDA acceptable limits is a pervasive and scattered problem throughout the current American supply chain. FDA has numerous responsibilities and limited resources with which to fulfill them, so it would not be reasonable to expect FDA to itself perform comprehensive batch-level testing. Nevertheless, the absence of such testing exposes the American people to demonstrable risk. For example the limited nature of FDA testing was unable to detect companies that currently have tainted batches in the American and Canadian markets. At least one company that consistently displayed high levels of NDMA in all Valisure-tested batches was a company whose metformin products, to Valisure’s knowledge, were not tested by FDA.”
“As Valisure’s results indicate, relying on pharmaceutical companies’ self-reporting of analytical results is not sufficient to protect the American pharmaceutical supply from potentially dangerous contamination. Furthermore, even when recalls are voluntarily performed by industry, the lengthy period of time over which such recalls occur is of significant concern to healthcare professionals, including those who have witnessed the over year-long recall process of the ARB medication recalls. It appears that the situation with metformin may be similar and a proactive drive for broad, independent testing should be combined with decisive action on the part of regulators to quickly request recalls and take other actions as appropriate. This is critical so that recalls of metformin do not plague the American healthcare system for years to come.”
If you or a loved one suffered injuries (or worse) as a result of a contaminated drug in the United States, you should promptly seek the legal advice of a pharmaceutical claim lawyer in your state who may investigate your drug claim for you and represent you or your loved one in a claim against a pharmaceutical company, if appropriate.
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