Another NDMA Drug Recall? What You Need to Know
You may have been hearing a lot about medication recalls in recent months due to impurities related to a substance called N-Nitrosodimethylamine (NDMA).
Medications included in the recall began with the popular blood pressure medicines losartan, valsartan and irbesartan, then included antacids such as ranitidine and nizatidine, and most recently, the diabetes medication metformin.
Which might have you worried and asking questions like “are any medications safe to take anymore?” or “I take one of these medications, what should I do?”
To answer these very valid questions, let's dig deeper into drug safety within the U.S. and learn more about the NDMA drug recalls.
How is Drug Safety Monitored in the U.S.?
The U.S. Food and Drug Administration (FDA) oversees safety regulations for various consumer products, including prescription and over-the-counter medications. Part of their job is to test batches (also known as “lots”) of the products for impurities.
When this quality testing shows an unacceptable level of an impurity, they issue a recall of the affected lot. Even if only one or two lots tested unacceptable for these impurities, a manufacturer could voluntarily recall all lots of specific products to be extra cautious, which is what happened to some of the recalled products related to NDMA impurities.
Why Are These Medications Being Recalled?
NDMA is part of a class of substances called nitrosamines. Nitrosamines are compounds that we are all exposed to at low levels in our everyday life, through water and some food, including meat, vegetables, and dairy products.
Nitrosamines like NDMA can also come from chemical reactions during the drug manufacturing process. Daily exposure to these substances in low-levels (called acceptable limits) is considered safe and NOT generally expected to have any adverse health effects (even with a long healthy life). Just like if you eat tuna fish (mercury), apples (seeds contain cyanide), or nutmeg (myristicin) in appropriate amounts, you typically have nothing to worry about.
Concern arises, however, when nitrosamines are present in amounts above acceptable limits combined with long-term exposure – as NDMA is considered a potentially cancer-causing agent. Currently, the FDA does not believe short-term exposure with levels above the acceptable intake limit increases the risk of cancer.
Therefore, since safety is the number one priority of the FDA, and out of an abundance of caution, affected drugs were recommended to be recalled by the drug manufacturers.
How Do You Know if Your Medication is Affected?
A great first place to begin is to call your pharmacist where you fill your prescriptions. They will have a record of your medication and can further direct you as to whether or not your medication is part of an FDA drug recall. Keep in mind that your pharmacy may not be able to tell you which exact lot number(s) you received.
You may also reach out to the FDA directly as the Division of Drug Information staffs pharmacists who are also available to answer drug questions:
- By phone at 1-855-543-DRUG (3784) and 301-796-3400
- By email at [email protected]
For more general information about drug recalls, you can visit the FDA’s websiteThe FDA has individual web pages set up for each of the drugs (losartan/valsartan/irbesartan, ranitidine, and metformin) affected by the NDMA recalls where you can catch updates and learn more about the recalls.
What If You Have a Recalled Medication?
Do NOT stop taking the medication without speaking with your healthcare provider first.
The NDMA-based recalls do not appear to pose an acute health risk, and no adverse effects have been reported to the FDA at this time.
Please talk to your pharmacist and/or doctor if you’re concerned about the recall and your unique health status or medication regimen. You may be able to use the same product made by a different manufacturer or a similar product used for the same condition.
The FDA, manufacturers, and your health care providers all care about your safety. The FDA and manufacturers continue to work together to test samples, investigate possible sources, and optimize the manufacturing process to prevent impurities.
You, as a consumer, can stay informed by signing up for FDA email alerts, contacting the FDA’s Division of Drug Information, or contacting your healthcare provider.