Pharmacy flags another valsartan impurity, argues FDA limits are too high

June 20, 2019

Online pharmacy Valisure reported that it found a new carcinogenic impurity in some lots of blood pressure medicine valsartan, but the amount is still well below levels the FDA deemed potentially harmful.

The Connecticut-based pharmacy informed the FDA, through a citizen petition, that it had found (through its own testing) an impurity called dimethylformamide (DMF) in some batches of the drug. DMF is classified by the World Health Organization as a probable carcinogen.

Last summer, the FDA began reporting that some generic versions  of the ARB meds contain nitrosamine impurities, which are probable human carcinogens. The agency initiated voluntary recalls of batches of valsartan, affecting multiple drugmakers such as Teva Pharma, Solco Healthcare, Sandoz and Mylan.

Valisure analyzed valsartan from multiple manufacturers including Novartis and several generic manufacturers, such as Aurobindo, Macleods and Lupin. The amount of DMF found ranged from 8 nanograms per pill to over 100,000 nanograms per pill — all significantly below the current permissible level of 8.8 milligrams per day.

It its petition, the pharmacy requested that the FDA do the following:

1) Review and significantly lower the acceptable intake/permitted daily exposure limit of DMF from its current level of 8,800,000 nanograms to less than 1,000 nanograms
2) Request a recall of identified lots of valsartan
3) Conduct examinations and investigation regarding these products, their manufacturing processes, and the manufacturer submissions made for FDA approval and effect labeling revisions as needed

Read the Bloomberg coverage.