Valisure warns FDA officials that the pharmacy found high levels of dimethylformamide in valsartan, a heart pill manufactured by Novartis. Valisure is an online pharmacy that has licenses to sell drugs in 37 states.
Valsartan, produced by Novartis and other pharma companies, is used to treat hypertension in adults.
Valisure is asking that the FDA review all of the medication and that a recall be issued during the review period. Valisure is also asking the FDA to lower the acceptable amount of dimethylformamide (DMF) to less than 1,000 nanograms. FDA officials have the acceptable level of DMF at 8.8 million nanograms. The online pharmacy claims to have found DMF in valsartan produced by five companies.
FDA officials warn that patients that are on blood pressure medication are not to stop using their drug. The FDA suggests that patients ask their doctor to provide an alternative medication until the evaluation of Valisure’s findings are complete. FDA officials will respond directly to Valisure on their findings.
Novartis made a statement claiming that the manufacturing process does not use DMF, but the company also claims that there is the possibility of trace amounts of DMF in the drug. The company is careful to state that DMF amounts, if they exist, are within the applicable limits.
Cancer-causing agents have been found in several blood pressure medications in the last four years. Teva Pharmaceuticals said earlier this month that the company will recall their heart medication losartan potassium.
The drug was evaluated and found to contain NMBA, a carcinogen. Numerous pharmacies have already recalled losartan.
Teva is also recalling all of their non-expired valsartan products in the US market. The company recalled all products that contain valsartan, including amlodipine-valsartan and amlodipine-valsartan-hydrochlorothiazide combinations of the tablets already.
Valisure claims that their testing found excessive amounts of DMF in six products, but the exact amount has not been released as of yet.
