Valsartan is listed as currently in shortage on the U.S. Food and Drug Administration’s (FDA) website. A series of recalls of the high blood pressure and heart failure medication have led to the shortage.
Drugs containing valsartan have been recalled because they may contain the cancer-causing impurities NDEA and NDMA. NDEA is classified by the World Health Organization as a group 2A carcinogen and is found in tobacco smoke. Scientists use NDEA to produce liver tumors they can study. NDMA is classified by the U.S Environmental Protection Agency as a probable carcinogen. It is given to rats to give the rats cancer which scientists can study.
Valsartan patients may consider switching to a different medication which isn’t currently in shortage to avoid medical issues. Serious medical issues can result from discontinuing valsartan use. Patients should consult with their physicians before discontinuing valsartan use and/or switching to a different medication. Valsartan is an angiotensin receptor blocker, or ARB. Eight ARBs are sold on the United States market and there are blood pressure medications which are not ARBs which may be an appropriate valsartan substitute. Those who use valsartan for blood pressure and switch from valsartan to another medication should pay close attention to their own blood pressure. A new medication can cause one’s blood pressure to react differently than it does to valsartan.
Switching medications isn’t an option for some patients. A valsartan patient told Wink News, “the alternate medication made my blood pressure really go off the charts.” The patient said that her pharmacy called her in November 2019 to tell her valsartan was on back-order. She said the valsartan recalls “threw [her] in a tizzy.”
“At this point of the year, now some of the wholesalers have none at all,” said a pharmacist in December 2019.
Valsartan was originally listed on the FDA drug shortages page on August 3rd, 2018. This came less than one month after the first valsartan recall due to NDMA contamination on July 16th, 2018.
It appears as if the contaminated lots of valsartan which were recalled became contaminated due to manufacturing changes. Valsartan manufacturing can create NDEA and NDMA when it is done in too acidic of an environment.
Properly formulated valsartan does not cause cancer. Only contaminated lots of valsartan can possibly cause cancer. Not all lots of valsartan have been recalled due to contamination. A complete list of valsartan recalls can be found at the FDA website.