Impurity in valsartan leads to voluntary recall
Posted: 6 August 2018 | Iqra Farooq (European Pharmaceutical Review) | 1 comment
Some drugs with active ingredient valsartan have been recalled due to presence of impurity NMDA…
Healthcare professionals and patients have been alerted by the U.S. Food and Drug Administration (FDA) of a voluntary recall of drugs containing the active ingredient valsartan. This active ingredient is used in drugs to treat high blood pressure and heart failure.
The impurity, N-nitrosodimethylamine (NMDA) was found in the recalled products. NMDA is known to be a probable human carcinogen, based on laboratory results. The presence of NMDA was unexpected and may be related to changes in the method the active substance was manufactured.
The FDA’s review is ongoing and has included examining the possible effect on patients who have consumed the drugs, measure to reduce or eliminate the impurity from future batches and the levels of NMDA in the recalled products.
FDA commissioner Dr Scott Gottlieb said, “The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured.
“When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”
The affected companies can be found here.
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Dr Janet Woodcock director of the FDA’s Centre for Drug Evaluation and Research.
The FDA continues to investigate this issue and will provide additional information when it becomes available. Any adverse reactions should be reported to the FDA’s MedWatch programme.
A short response from a person directly affected by the NMDA laced Valsartan. My understanding it was the European equivalent of our FDA that made the discovery and alerted the world. It may be that they did not make the discovery but did alert the world which then prompted a response from within this country. The undetected levels have been reported to be 5 times higher than the limits allowed. Other articles suggest the NMDA issue dates back to 2012. All articles seem to be well documented. A sad commentary for affected people that relied on a “Gold Standard” approach to protecting citizens of this country from foreign made generics. The companies that manufactured and distributed the NMDA Valsartan should be forced to pay for independent labs selected by the victims of the failed “Gold Standard” to get factual data on the actual levels of NMDA in their Valsartan. The short term and long term effects of NMDA are horrific, and no one seems accountable. I’ve traced one contaminate lot that I have been taking for 6 months. I working on finding the other lot number prior to the current lot numbers. That would mean no testing has been done in 6 months or longer or if testing was done, the results were not publically disclosed. I’m grateful for the Europeans alerting the world to NMDA in Valsartan. Its sad that the safety of US citizens has to come from off shore.