FDA recalls heart medicines contaminated with possible carcinogen
December 04, 2018 at 7:39 PM
FDA recalls medications contaminated with possible carcinogen
If you are taking a medicine for high blood pressure or heart disease, please listen up.
The FDA has found that certain medicines manufactured in China are contaminated with small amounts of a chemical called NDMA or N-nitrosodimethylamine, a member of a group of chemicals called nitrosamines. They have been found to cause cancer when given in large doses to rats and are suspected to possibly cause cancer in humans exposed to even small amounts for prolonged periods of time. You might remember when there was a lot in the news about the possible risk of nitrosamines causing cancer because they are produced when you smoke tobacco or grill meat over an open flame.
It is critical that people taking these medicines do not stop taking them without first checking with their physician.
The potential harm from stopping treatment of high blood pressure or heart disease is greater than the possible small and theoretical risk of cancer from these chemicals.
The medicines are:
Valsartan with amlodipine and/or hydrochlorothiazide (HCTZ)
Are all medicines with these ingredients contaminated with NDMA? NO!
Not all products with these medicines are being recalled, only certain batches produced for two manufacturers. However, medicines are usually produced in bulk and are often repackaged and sold by many small companies.
At this time, only some of these products are being recalled and the following are some of the companies making the recalls:
- Solco Healthcare
- Bryant Ranch Prepack
- HJ Harkins Company
- Northwind Pharmaceuticals
- Teva Pharmaceuticals (some labeled Actavis)
- A-S Medication Solutions
- Proficient Rx
- Remedy Repack
- ScieGen Pharmaceuticals (labeled as Westminster Pharm and Golden State Medical Supply (GSMS)
What are these medicines and why might you be taking one or more of them?
Drugs with names that end in “sartan” are in a group that are all ACE inhibitors because they block an enzyme in the body that controls blood pressure.
Amlodipine is a medicine that blocks the actions of calcium in blood vessels and dilates the vessels to lower pressure.
HCTZ is a diuretic that increases the amount of sodium that goes into the urine and thereby also lowers blood pressure.
All of these medicines are prescribed, often in combination, to lower blood pressure and/or to reduce the risk of heart failure in people with heart disease.
What should you do if you are taking one of these medicines? Contact your pharmacist or go online to check the lists of products that have been found to be contaminated.
If you are taking any medication containing valsartan, amlodipine, losartan or irbesartan you can compare the name on your prescription bottle to the FDA's posted list to determine if the lots you are taking have been recalled. Go to FDA.gov at:
You can also contact your pharmacist, who should be able to provide you with medication from a drug maker not involved in the recall.
IMPORTANT: People who are taking these medications should continue taking them until their doctor or pharmacist has provided a replacement medication. The risk of harm from stopping these medicines is greater than the possible risk of liver injury or cancer from any NDMA they might contain.
The Environmental Protection Agency considers NDMA to be a carcinogen that, in large doses, can cause liver damage in humans. Animal studies suggest that long term exposure to very small amounts may cause liver or pancreatic cancer. The FDA estimates that one additional case of cancer could develop over the lifetime of 8,000 patients if they had all taken the highest valsartan dose (320 mg) from the recalled batches daily for four years – the length of time that low levels of the NDMA may have been in the products.
A recent study from Denmark followed 5150 patients taking contaminated valsartan over ~5 years (median of 4.6 years) and found no significant increased risk of cancer but they recommended longer followup of these patients to more accurately assess the risk.
Important message: Medicines like valsartan save lives. Be sure to take all of your medicines as directed but also be alert to be sure you are fully informed about how to use them safely. Visit CredibleMeds.org for the most up-to-date and trusted information.
PS: Don’t forget your Flu vaccine. Critically important.
Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3851 (Published 12 September 2018)Cite this as: BMJ 2018;362:k3851