On July 5, 2018 the European Medicines Agency announced a recall of a generic blood pressure medicine called valsartan (Diovan). The active ingredient in some generic formulations was apparently contaminated with a carcinogen called NDMA. Read our first health alert here. On July 17, 2018 the FDA announced a voluntary recall and shared this: “The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied to them by Zhejiang Huahai Pharmaceuticals, Linhai, China.” The companies were Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceutials. But some pharmacists were reluctant to take back recalled valsartan as this reader points out.
Recalled Valsartan: Who’s Responsibility?
Q. What can you tell me about the recalled valsartan? I have been taking the Solco product for some time. When I spoke with the pharmacist yesterday I was brushed off as if there was no problem. He acted as if the recall wasn’t a big deal and that they were doing nothing about it.
Should we customers call the FDA for advice? I am concerned about continuing to take the 90-day prescription that was filled a few days ago.
A. Valsartan (Diovan) is a widely prescribed heart and blood pressure medicine. The recall IS a big deal! Some generic valsartan pills were contaminated with (NDMA), a probable carcinogen.
A Chinese company (Zhejiang Huahai) sold contaminated valsartan to a number of generic drug manufacturers around the world. Solco Healthcare U.S. is a subsidiary of Huahai. Other U.S. companies affected include Major Pharmaceuticals and Teva’s Actavis valsartan.
The FDA states that:
“patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.”
The FDA also notes that:
“Zhejiang Huahai has stopped distributing its valsartan API [active pharmaceutical ingredient] and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products.”
Your pharmacy should provide you unaffected valsartan at no extra cost. If there are shortages, your doctor could prescribe a similar medication such as irbesartan, losartan, olmesartan or telmisartan.
What We Don’t Know About the Recalled Valsartan:
There are many unanswered questions regarding the recalled valsartan. Here are just a few of our concerns?
When did the contamination first occur?
A report from Reuters suggested that the carcinogen might have occurred as early as 2012.
Did the FDA discover the problem?
As far as we can tell, the FDA followed the European Medicines Agency in recall. Why didn’t our regulators discover the problem sooner?
If people have been swallowing a carcinogen daily for years, who’s responsible?
If someone taking the recalled valsartan gets cancer, is anyone responsible? Will the FDA require the Chinese company to do any epidemiological follow up?
Will we ever know if people have been harmed?
Our guess is probably not. The FDA has been notoriously lax in requiring long-term cancer studies regarding medications.
You can read more of our questions for the FDA at this link.
Our Guide to Blood Pressure Treatment provides information on other options to control hypertension along with a number of non-drug options. Share your own thoughts about the pharmacist’s responsibility for taking back and refunding patients for recalled valsartan.