Pharmacy takes FDA to task in citizen petition over tainted valsartan

fiercepharma | June 20, 2019

The FDA has tied the contamination of blood pressure drugs by probable carcinogens to an approved switch in manufacturing to a process that uses certain solvents. Now an online pharmacy says it has discovered the solvents are as bad as the impurities they have been creating and has criticized the FDA for not taking steps to limit their use. In a citizen petition, the New Haven, Connecticut-based Valisure says the FDA has established acceptable limits for impurities such as those commonly known as NDMA and NDEA after they were discovered in heart drugs last year, leading to massive global recalls. But it claims the FDA has not lowered the acceptable level for the solvent DMF, although it “has become apparent that the switch in the manufacturing industry to the use of the DMF solvent may be largely responsible” for the appearance of the impurities in the U.S. drug supply. “This disparity lacks a rational basis and is of significant concern, particularly because of Valisure’s recent findings that high levels of DMF exist in certain on-market lots of valsartan medication,” Valisure’s petition says. The petition says the FDA needs to investigate the use of the solvent N,N-Dimethylformamide (DMF) in drug manufacturing since it is classified as a Class 2 carcinogen. It should lower the acceptable level of its use in the U.S. drug supply and requested the FDA seek the recall all of the drugs in which it is found in levels that exceed its guidance.

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Spotlight

Fever is the body’s response to a threat. When some viruses or bacteria try to enter the body, an immune response begins that can include a sharp rise in body temperature. It happens in the flu, upper respiratory infections, common colds and lots of other illnesses.

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