Potential Nitrosamines in Your Prescription
Potential Nitrosamines in Your Prescription: What You Need to Know and Take Action
Patient safety remains paramount to the FDA. The U.S. Food and Drug Administration is actively investigating several substances, known as nitrosamines, which have been recently detected in certain medications used to manage conditions like high blood pressure, heartburn, acid reflux, and diabetes. Some of these medications, manufactured by specific companies, such as angiotensin II receptor blockers (ARBs), ranitidine, nizatidine, and metformin, have been recalled due to the presence of nitrosamine impurities.
The FDA has directed manufacturers to withdraw all ranitidine (marketed as Zantac) products from the U.S. market, acknowledging the gravity of the situation. Recently, the FDA disclosed findings of elevated levels of a specific nitrosamine called N-Nitrosodimethylamine (NDMA) in certain extended-release formulations of metformin, prompting voluntary recalls by five manufacturers.
In addition to these actions, the FDA is compelling all manufacturers of extended-release metformin to assess the risk of excessive NDMA and conduct thorough testing before releasing batches to the market. Ongoing collaboration with drug manufacturers is crucial to pinpoint the source of nitrosamines and assess potential health risks.
Nitrosamines are naturally occurring compounds found in our environment, including food and water, and can form during drug manufacturing processes. While exposure to some nitrosamines above acceptable levels over prolonged periods may heighten cancer risks, typical use of medications containing NDMA within acceptable limits is not expected to increase cancer risk.
If you're worried about your medication:
Continue Taking Your Prescriptions: Consult your healthcare provider before discontinuing any medications. They possess comprehensive knowledge of your health status and can advise on the best course of action, including alternative treatments if necessary.
Find Out if Your Medication Is Recalled or Affected
If you want to know whether your medications have been recalled or not, call your pharmacist or the FDA. The FDA’s Division of Drug Information (DDI) will solve any query to your drug recall question.
For general recall information, visit the FDA website. The FDA also has specific pages for metformin, ARBs (valsartan, losartan, and irbesartan), which are used to treat high blood pressure and heart failure, and ranitidine, which is used to treat acid reflux.
If your medication is not recalled or withdrawn, continue to take it, and stay informed. Sign up for FDA email alerts about your medications here to get timely updates.
Follow Advice if Recalled:
If your medication is affected by a recall procedure followed by the FDA, then call your pharmacy. They’ll know if the medication given to you is part of the recall by the FDA. If it was, talk to your pharmacist and health care provider to discuss what can be done, including switching to the alternate drug, so that you don’t go without required medical treatment.
The FDA encourages patients to talk to their healthcare professional if they have questions about their medicine, as the risks of stopping their medicine may outweigh the potential risk of exposure to nitrosamines. The FDA and the international scientific community do not expect nitrosamines to cause harm when ingested at low levels. The FDA urges patients to continue to take their medications and check with their healthcare professionals about alternative treatments if needed.
