Hypertension is the leading cause of heart and kidney disease and various comorbid conditions like diabetes.
So when the Food and Drug Administration (FDA) began recalling valsartan in July due to the drug containing a cancer-causing impurity, patients became concerned; just how far does the recall go?
Two weeks ago, the voluntary recall expanded to 22 countries, pulling more than 2,400 batches — more than half of valsartan pills in the US — off of the market.
The issue with valsartan
The recall involves two factories abroad: the Zhejiang Huahai factory in China and Hetero Labs Limited in India. The facilities have been identified as creating tainted N-nitrosodimethylamine (NDMA), the active pharmaceutical ingredient in valsartan.
The factories sell NDMA to various manufacturers in the US for repackaging, making it difficult to track which factory produced the ingredient. Thirteen manufacturers have been named in the recall so far. And as the FDA continues to evaluate valsartan from additional manufacturers, the recall could continue to multiply.
NDMA is also found in food, water and dairy products. An allowable daily intake is 96 nanograms. As a patient, you will not know if your valsartan takes you above the limit. High levels of NDMA have been shown to cause cancer in animal studies.
The FDA estimates that there will be one extra cancer case out of every 8,000 patients taking the maximum dose 320 mg of valsartan for four years.
While the highest dosage has the highest risk, other dosages and types can be affected. Valsartan comes in four variations, including:
- Valsartan and hydrochlorothiazide
- Valsartan-amlodipine combination
- Valsartan-amlodipine-hydrochlorothiazide combination
What you should do
Don’t panic and do not stop your medication. Doing so will increase your blood pressure, and can also precipitate heart failure.
However, be proactive and call your doctor to discuss alternative options to control your high blood pressure. You should not call your pharmacy, as they will not know which factory the NDMA was produced in. The safest bet is to switch medications until the recall gets sorted out.
There are several hundred hypertension drugs, including seven other members of the angiotensin II receptor blocker class, including irbesartan, losartan, candesartan, olmesartan, telmisartan, eprosartan, and azilsartan. From a study of 135,000 participants, patients who have taken these have shown no increase in cancer when compared to placebo or ACE inhibitors. There are also other anti-hypertensive agents that can be taken, such as diuretics, calcium channel blockers, beta blockers and ACE inhibitors. These families of medications have been used for decades and are just as good.
Not every apple is the same, though. Schedule an appointment and discuss these options with your physician. The recall has been voluntary for patients and it is up to them to identify themselves as being effected (doctors cannot search electronic health records to see who is taking valsartan).
Whichever medication you switch to, make sure to have your blood pressure checked after taking the pill.
Guy Mintz, MD, is director of cardiovascular health and lipidology at the Sandra Atlas Bass Heart Hospital at North Shore University Hospital. He is also a clinical associate professor of medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell.