Bad news for patients who take metformin. This generic medication that is widely prescribed around the globe for people with type 2 diabetes.
After initially concluding that this drug did not contain high levels of NDMA, a potential carcinogen, the FDA has now decided to move forward with a recall.
Independent Lab Challenges FDA
In February, the FDA tested lots of metformin and found slightly elevated levels of NDMA. The agency did not believe the levels were high enough to recommend a recall at the time.
Independent laboratory Valisure didn’t buy it. They conducted their own investigation. What they found were dangerously high levels of the compound. Several of the batches tested had more than 10 times the acceptable limit. Valisure also reported wildly different levels, even in batches from the same company.
The lab concluded that there was a real and serious problem with NDMA in the worldwide supply of metformin. Faced with the evidence, the FDA had to agree.
At this time, we don’t know exactly how many lots of the drug will be recalled. In fact, we don’t even know how many manufacturers may eventually perform voluntary recalls. The FDA stated that they will need time–potentially months–to conduct a more thorough investigation.
One potential upside is that only the extended-release versions of metformin are being recalled at this time. The immediate-release pills are by far the most commonly prescribed version of the drug, so it’s not the worst possible scenario for diabetes patients.
However, patients who currently take the ER version of metformin need to speak with their healthcare provider. So far, only medication made by Apotex Corp is officially recalled. A total of 5 companies are being investigated by the FDA, and it is likely that more will join Apotex in this massive recall.
What Is NDMA?
NDMA, or N-nitrosodimethylamine, is a potential carcinogen. It has been found in multiple drugs in the last few years. The more scientists test using gas chromatography and mass spectrometry, the more they find. It is linked to a slightly increased risk of cancer.
If you followed our coverage of the Zantac recall, then you might recognize NDMA. This compound was found at unacceptable levels in all ranitidine-based heartburn medications. That included both over-the-counter medications, like Zantac, as well as prescription drugs.
Scientists aren’t completely sure where this contaminant is coming from. The leading theory is that it involves the breakdown of compounds in the drugs. Older medicines, such as those that have been sitting on the shelf at a pharmacy or your medicine cabinet, have consistently revealed higher levels of NDMA than drugs that were freshly manufactured.