The news first broke in the summer of 2018 when certain companies with some forms of contaminated valsartan announced they would be taking their medicines off shelves. As more companies began to look into their own production timelines and factories, more recalls came to light.

So far, the FDA knows that there are 53 different recalls impacting medicines containing valsartan. Not every drug with valsartan inside has been subject to a recall, however. The recalls came about following discoveries of potential contaminants NDEA and NDMA, but other news stories have profiled additional concerns over contamination.

More than 1,000 different lots of medications have been affected by all the recalls.

What Is the Cancer Risk with These Drugs?

The cancer risk in the recalled medications has to do with contaminants that could have gotten into the drugs during the manufacturing process. In total, NDEA, NDMA, and NMBA were all found in various lots of the valsartan drug, leading to panic over the problem with valsartan.

The FDA has already classified the first two impurities mentioned above as probable human carcinogens, whereas NMBA is still known as a potential human carcinogen. These could have gotten inside the medications because of the reuse of materials like solvents or when reactions and certain chemicals are part of the active pharmaceutical ingredient in the medicine.

According to GoodRx, the presence of these impurities increases the cancer risk only slightly. However, many valsartan patients still have legitimate reasons to be concerned, especially if they had been taking this drug for a long period of time at a high dosage.

If you believe that you might have developed some sort of medical condition or problem from taking contaminated valsartan, you might need to speak with your doctor immediately about what to do next. Your doctor can help you figure out if your version of the medication was impacted and whether or not you should switch to something else in the interim. You can also complete research online to determine whether or not your medicine was named in any recalls because of the problem with valsartan.

What Happened When the Recalls Starting Coming Out?

Numerous companies have announced recalls of their versions of valsartan, which in some ways led to panic for patients who believed that they were at risk of getting cancer. The contaminants found in the medicines can increase a patient’s risk of developing cancer in the future, but the medication could also be preventing serious health conditions from getting worse.

Some people taking versions of affected valsartan contacted their doctors immediately and asked for more information about what to do next. Others stopped taking the medications right away, which comes with risks for the patient.

How Did Valsartan Become Contaminated with NDEA, NDMA, and NMBA?

Although it is currently unknown exactly how the affected lots of valsartan became contaminated by potential carcinogens, there are several possible theories. It is likely that the drugs may have become contaminated at some point during the manufacturing process. In late 2018, the FDA announced that the organization would be launching investigations into several factories responsible for producing valsartan. These factories are mostly overseas, as approximately 80 percent of drug ingredients for medications sold in the U.S. are produced in other countries.

In August 2019, another update was released by the agency assuring consumers that they were working diligently to help eliminate contamination in valsartan and other high blood pressure medications.

“We continue to work closely with our global regulatory partners, including the European Medicines Agency (EMA), Health Canada, and many others, to understand the full scope of this issue,” the FDA said in a statement.

“We are working to incorporate what we have learned about the process risks that caused these impurities into our oversight of drug manufacturing, which includes how we assess applications and changes to applications, as well as enhancing our inspection coverage to evaluate the controls in place to prevent unacceptable levels of nitrosamine.”

According to reports from the FDA, manufacturing violations were found at some of the factories where valsartan is made. One factory was found to have facilities and equipment that were unclean or in states of disrepair. Additionally, anomalies that were found during drug testing at the factory were not followed up on, and impurities discovered in some drugs were written off as laboratory errors instead of being investigated.

Several manufacturers of active pharmaceutical ingredients, or APIs, have received warning letters from the FDA as a part of the agency’s ongoing investigation into valsartan contamination.

In November, Mylan Pharmaceuticals – an Indian pharmaceutical manufacturer – was sent a warning letter for failing to follow several current good manufacturing practices. The FDA detailed a variety of deviations including failure to establish written procedures for receiving, identifying, and handling raw materials. The factory was allegedly also warned for failure to clean equipment.

Less than a month earlier, Torrent Pharmaceuticals – another Indian pharmaceutical manufacturer – also received a warning letter about manufacturing violations. According to the FDA, the company failed to follow their established written procedures for both product and process control. Additionally, the manufacture reportedly failed to adequately investigate discrepancies between API batches. Torrent had previously been involved in the valsartan recall, recalling several lots of their medications.

According to a former FDA inspector who visited one of the labs that were found to have produced tainted valsartan, employees spent several days prior to his visit shredding documents in order to cover up systemic issues at the manufacturing plant. Due to the lack of follow up on impurities or testing anomalies, it is unknown how long the tainted valsartan may have been on the market, and how many people may have been affected by the problem with valsartan.

What’s the Risk in Stopping Valsartan?

If you were put on any blood pressure medication because of potential health risks, it’s very important to discuss your decision to come off valsartan or any other medication with your doctor first. This is because if you were at risk of a serious blood pressure event, the sudden loss of that medication could compound your underlying health risks.