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On July 13, the Food and Drug Administration (FDA) announced that it had asked several companies that market valsartan medications — which are approved by the FDA to treat hypertension and heart failure[1] — to recall all unexpired lots of these products because the drugs had been found to be contaminated with N-nitrosodimethylamine (NDMA), a probable human carcinogen (a substance that could cause cancer).[2] Importantly, not all companies that market valsartan products needed to recall...
On July 13, the Food and Drug Administration (FDA) announced that it had asked several companies that market valsartan medications — which are approved by the FDA to treat hypertension and heart failure[1] — to recall all unexpired lots of these products because the drugs had been found to be contaminated with N-nitrosodimethylamine (NDMA), a probable human carcinogen (a substance that could cause cancer).[2] Importantly, not all companies that market valsartan products needed to recall these drugs.
The FDA action followed swifter actions by drug regulatory agencies in Europe and Canada. On July 5, the European Medicines Agency (EMA) announced that national authorities in European Union countries were recalling several valsartan medications for the same reasons now cited by the FDA,[3] as did Health Canada on July 9.[4]
The source of the contamination in the initially recalled products was the bulk active ingredient valsartan that had been produced by the Chinese company Zhejiang Huahai Pharmaceuticals. The detection of NDMA in the valsartan was unexpected and is thought to be related to changes in the way the active ingredient was manufactured.[5]
On July 27, the FDA reported that valsartan medications containing NDMA may have been on the market for as long as four years.[6] Agency scientists estimated that if 8,000 patients had taken the highest valsartan dose (320 mg) from the recalled batches daily for the full four years, there may be one additional case of cancer over the lifetimes of these 8,000 patients.
Since the agency’s initial announcement about the recall of valsartan medications, the list of recalled products has gradually expanded. On August 9, the FDA also announced that bulk active ingredient valsartan produced by a second company, Hetero Labs in India, was found to be contaminated with NDMA, although the levels of contamination were lower than those found at Zhejiang Huahai Pharmaceuticals..[7] For a current list of valsartan products recalled in the U.S., check the FDA website at https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm. The recalled products are various doses of single-ingredient valsartan tablets and combination valsartan-hydrochlorothiazide tablets.
Note that other manufacturers of valsartan-containing products obtain the bulk active ingredient valsartan from other companies, and their products are not subject to these recalls.
Valsartan is one of several hypertension drugs called angiotensin II receptor blockers (ARBs) available in the U.S. that all work the same way (see Table). Note that we have designated one ARB, olmesartan (AZOR, BENICAR, BENICAR HCT, TRIBENZOR), as Do Not Use because it can cause a serious gastrointestinal disorder called sprue-like enteropathy.
List of Angiotensin II Receptor Blockers Available in the U.S.
| Generic Name | Brand Name Products |
|---|---|
| azilsartan | EDARBI, EDARBYCLOR* |
| candesartan | ATACAND, ATACAND HCT* |
| eprosartan | generic only |
| irbesartan | AVALIDE,* AVAPRO |
| losartan | COZAAR, HYZAAR* |
| olmesartan** | AZOR,* BENICAR, BENICAR HCT,* TRIBENZOR* |
| telmisartan | MICARDIS, MICARDIS HCT,* TWYNSTA* |
| valsartan | BYVALSON,* DIOVAN, DIOVAN HCT,* ENTRESTO,* EXFORGE,* EXFORGE HCT* |
*Combination products
**Do Not Use
What You Can Do
Because valsartan is used to treat serious medical conditions, if you are taking a recalled valsartan-containing product, you should continue taking it until you can get a replacement valsartan or are prescribed another ARB product (other than olmesartan).
To determine whether a specific valsartan product has been recalled, you should look at the drug name and company name on the label of your prescription bottle and compare it with the list of recalled products on the FDA’s website. If the information is not on your bottle or you are unable to access the FDA’s website, you should contact the pharmacy that dispensed the medication.
References
[1]Novartis. Label: valsartan (DIOVAN). January 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021283s50lbl.pdf. Accessed July 17, 2018.
[2]Food and Drug Administration. FDA news release: FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity. June 13, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM613532.htm. Accessed July 17, 2018.
[3]European Medicines Agency. EMA reviewing medicines containing valsartan from Zhejiang Huahai following detection of an impurity. July 5, 2018. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/07/news_detail_002984.jsp&mid=WC0b01ac058004d5c1. Accessed July 17, 2018.
[4]Health Canada. Recalls and safety alerts: Several drugs containing valsartan being recalled due to contamination with a potential carcinogen. July 9, 2018. http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67202a-eng.php#hc-sc. Accessed July 17, 2018.
[5]Food and Drug Administration. FDA news release: FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity. June 13, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM613532.htm. Accessed July 17, 2018.
[6]Food and Drug Administration. FDA updates on valsartan recalls. https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm. Accessed August 13, 2018.
[7]Ibid.
