Dive Brief:
- The Food and Drug Administration announced Thursday that more than half of all valsartan products are now under recall, and more recalls could be coming.
- The FDA's investigation into impurities found in certain generic versions of the blood pressure medication valsartan is ongoing, with the agency's multidisciplinary team of investigators edging toward an identification of the root cause.
- As well as recalling products and informing both healthcare professionals and the public, a team at the FDA's advanced pharmaceutical laboratory investigated whether the contamination resulted from a change in the manufacturing processes at Zhejiang Huahai Pharmaceutical.
Dive Insight:
The valsartan story began in June, when the drug company Prinston Pharmaceuticals raised the concern that its active pharmaceutical ingredient supplier, Zhejiang Huahai Pharmaceutical, found small but unacceptable amounts of N-nitrosodimethylamine (NDMA) in the valsartan active pharmaceutical ingredient. The company alerted the FDA's Center for Drug Evaluation and Research (CDER).
NMDA is found in water and some foods at trace levels, and is potentially carcinogenic. The next step for regulators was to find the companies affected by contaminated API and suggest product recalls.
"The initial recall has expanded to now include five manufacturers and other companies who repackage those products under a different name," FDA Commissioner Scott Gottlieb and CDER Director Janet Woodcock said in a joint statement. "More products may need to be recalled."
The FDA has been collaborating and sharing findings with fellow regulating bodies in Europe, Canada and Japan.
While the cause of the impurity is not yet clear, the agency believes "a combination of conditions, which include certain chemicals, processing conditions and production steps, could lead to formation of the NDMA impurity. We believe that these risks are introduced through a specific sequence of steps in the manufacturing process, where certain chemical reactions are needed to form the active ingredient."
Though product recalls do protect the public, they also lead to worries that people will stop taking their medication unnecessarily, and can also lead to shortages of the drug. In the case of valsartan, this can amplify the risk of serious medical issues such as stroke. To offset this, the FDA attempted to allay concerns by clarifying which products are affect by the recall efforts.