As we first reported in July, FDA is in the process of recalling a common heart medication because it is contaminated with cancer-causing substances. It's become a massive undertaking that has shaken America's confidence in pharmaceutical manufacturing.
Valsartan, a generic ingredient that helps people with high blood pressure and heart failure, has been under a voluntary recall since July. The drugs were tainted with N-nitrosodimethylamine, or NDMA, which is considered a carcinogen by the EPA.
NDMA is used to make liquid rocket fuel, and it's a byproduct from manufacturing some pesticides. NDMA can be unintentionally introduced into manufacturing through certain chemical reactions.
Not all versions of the drug have been recalled. The FDA keeps a regularly updated list of the drugs that have been impacted as they continue their investigation.
The FDA said they will continue to test all products that contain valsartan.
Now, the situation has become even more serious. The FDA found a second, unexpected impurity in 3 lots of Torrent Pharmaceuticals’ recalled valsartan containing drugs. The additional impurity was found in products included in the company’s August 23 recall of drug products containing the active pharmaceutical ingredient (API) valsartan.
In addition to the expected NDMA, they also found N-Nitrosodiethylamine, or NDEA, which is also a suspected human carcinogen. The FDA says they will continue to test the recalled drugs for the additional contaminate.
In response to the second impurity being identified, Health Canada advised patients to speak to their doctors about switching to another version of valsartan that isn't contaminated. The FDA suggests continuing to take the drug until a doctor or pharmacist provides a replacement.
They said, "As we continue to investigate the root cause of the impurities found in products that contain valsartan, our scientists are testing these products to better understand these impurities and to ensure they're not present in other products. We're also taking steps to make sure we're providing stringent oversight of manufacturing processes to reduce the likelihood that impurities could be introduced into other products," said FDA Commissioner Dr. Scott Gottlieb. "As we expand our investigational efforts, we'll continue to make sure the public has the most up-to-date information. We'll also continue to work with global regulatory agencies to learn as much as we can about how these impurities came about and how they may affect patients' health around the globe."
Consumer Safety is coordinating a lawsuit. They have details about who is eligible on their website.
"The risk of developing cancer from the traces of NDMA found in contaminated valsartan is still unknown. However, NDMA can also cause other problems, such as liver damage. Anyone who takes valsartan should talk to their pharmacist or healthcare professional to see if their prescription is included in the recall and to receive a different medication, if necessary," added Consumer Safety.
Please pray for everyone who has been taking the drug over the past years. You can find out more about the details of the drug here.