Pharmaceutical company Mylan is expanding its voluntary nationwide recall of its blood pressure medications.
Two weeks ago, the drug maker recalled some lots of its valsartan-based products after detecting trace amounts of a cancer-causing chemical.
According to the US Food and Drug Administration (FDA), the presence of the carcinogen could have resulted in changes in the way the drugs were manufactured.
On Tuesday, Mylan announced it was recalling another 104 lots – in addition to the 15 already recalled – ‘out of an abundance of caution’.
Valsartan is used to treat high blood pressure and heart failure as well as lower the risk of death after a heart attack.
It is in a class of drugs known as Angiotensin Receptor Blockers, which block a natural hormone called angiotensin II that narrows arteries.
When used in combination with amlodipine or hydrochlorothiazide, it is solely used for treating high blood pressure.
In an announcement posted on the FDA website, Mylan said lab tests of the drug showed trace amounts of a chemical called N-nitrosodiethylamine (NDEA).
The International Agency for Research on Cancer has classified NDEA, which is found in tobacco smoke, as a probable human carcinogen.
On November 20, Mylan announced it was recalling 15 lots of tablets containing valsartan.
The expanded recall includes an additional 104 lots including valsartan tablets, valrsartan/amlodipine tablets, and valsartan/hydrochlorothiazide tablets – all of which have varying strength.
This is not the first time valsartan-based products have been recalled by pharmaceutical companies due to a presence of carcinogens.
In July, the FDA issued a voluntary recalled of five medications with a valsartan/hydrochlorothiazide combination after laboratory tests revealed small amounts of another chemical classified a probable human carcinogen.
And last month, Teva Pharmaceuticals, an Israeli drug company, pulled all valsartan products after finding high amounts of NDEA.
According to a statement from Mylan, the recalled products were distributed in the US between March 2017 and November 2018 and all have expiration dates in 2019 and 2020.
Mylan is recommending that anyone taking the prescribed drug contact their doctor about alternative treatments.
However, the FDA suggests taking it in the meantime because stopping it abruptly can lead to a rapid rise in a blood pressure and cause even further ill effects.
Mylan says consumers can contact Stericycle at 1-888-406-9305 during business hours Monday through Friday to return their recalled products.
After the announcement, shares of the company fell two percent to $33.40.