Multiple commonly prescribed drugs meant for the treatment of high blood pressure and heart failure, including valsartan, have recently been recalled due to an impurity in the medication that may result in an increased risk of cancer for patients.

Patients who have been prescribed these medications may want to consult with their doctor regarding whether they should stop taking valsartan. The Food and Drug Administration (FDA) makes it clear that patients should not stop taking valsartan without first consulting their doctor.

Why Was Valsartan Recalled?

The voluntary recall was announced on Oct. 24, 2018, by Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries. The drugs included in the recall include valsartan and valsartan/hydrochlorothiazide. More than 2,300 lots of the drugs are included in the recall.

According to lab tests, the impurity found in the drugs is N-nitrosodimethylamine or NDMA, a probable human carcinogen. The U.S. Food and Drug Administration released a statement about the recall noting that the presence of NDMA in the medication was unexpected, and was thought to be caused by changes in the way that the medication is manufactured.

Valsartan was recalled over concerns that it could have been contaminated with NDMA during the manufacturing process. Not all batches of valsartan were recalled, reports CNN, because some valsartan medications were not part of the batches produced while there were problems in the manufacturing process. Happily, this means that patients taking affected valsartan do have some options if their doctor advises them to stop taking valsartan or switch medications while their primary medication is being recalled, says CNN.

However, the FDA is still working to find out how exactly problems with the manufacturing process led to the development of NMDA. Thus far, the FDA has taken steps to warn manufacturers about the possible contamination risk and to urge them to take steps to make sure that similar problems do not occur in the future.

The United States is not the only country to have issued a valsartan recall over NDMA contamination concerns. According to CNN, 23 countries in total have issued valsartan recalls, affecting valsartan made by multiple manufacturers.

Unfortunately, the amount of NDMA present in valsartan, possibly linked to the manufacturing problem, is a significant one. The FDA has deemed an acceptable daily amount of NDMA ingestion to be 96 nanograms per tablet, but according to some consumers, contaminated valsartan can contain as much as 200 times this daily acceptable amount.

According to news sources, the NDMA concern is not limited to valsartan. Healthline explains that other drugs like valsartan are being recalled. Other angiotensin II receptor blockers including losartan and irbesartan have also been subjected to recalls.

Who May Be Affected by the Valsartan Recall?

Patients around the world may be affected. Many countries have recalled the tainted valsartan, including Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain, and Malta.

Patients who are concerned that they may be in possession of the tainted valsartan may be able to check the lot numbers on their medication against the lot numbers listed on the FDA recall page.

What Are the Uses and Side Effects of Valsartan and NDMA?

Valsartan belongs to a class of drugs known as angiotensin receptor blockers (ARBs). ARBs work by relaxing the blood vessels to allow blood to flow more easily and lower blood pressure. Heart medication valsartan is used to treat high blood pressure and heart failure, as well as to improve the patient’s chances of living longer after having a heart attack.

It may also lower the likelihood of hospitalization for patients with heart failure. It may help to prevent strokes, heart attacks, and kidney problems. However, tainted valsartan may increase some of these health problems.

While relatively little is known about the long term risks associated with NDMA, it is thought that the side effects would be connected to the amount of NDMA consumed. According to lab studies on rats, the toxin can cause liver problems, including liver fibrosis, liver scarring, and liver tumors. There is also a suspected risk of cancer associated with the chemical.

Should I Take Another Blood Pressure Drug?

If your doctor has prescribed a blood pressure medication, you should take it for as long as prescribed exactly as the doctor recommended. If you are no longer taking valsartan medicines due to the contamination problems, it’s still not a good idea to tell your doctor which drug you personally want to take.

Your doctor should consider the possible side effects and which of the medicines on the market might be the right fit for your individual condition.

Some patients are tempted to stop using their medicine altogether, which can be dangerous for the blood pressure condition. It’s also not a good idea to try taking the medicine every other day or cutting the pills in half to try to make them last longer. This can dilute its effectiveness and impact your blood pressure negatively whether your valsartan comes as capsules, a liquid, or tablets. The recommended dose was based on your age, weight, and the seriousness of your blood pressure issues.

Those who do cut pills in half or skip what has been recommended by the doctor are at risk of kidney failure, heart failure, stroke, and heart attack.

Especially since valsartan is used to treat heart failure or help a person after a heart attack, stopping this medication without a doctor’s insight is dangerous. If you are thinking you should stop taking valsartan as a result of the concerns over contamination, set up an appointment at your doctor’s office to talk options.

What Can Patients Do?

Patients who are concerned about the recall may check the FDA’s recall page for valsartan. However, patients are recommended not to stop taking valsartan without first speaking with their doctor.

Patients who have been diagnosed with cancer or other serious health conditions as a result of consuming tainted valsartan may be able to hire a qualified attorney and file a class action lawsuit.

Victims who file class action lawsuits regarding valsartan injuries may be able to pursue compensation for injuries, pain and suffering, medical expenses, loss of income, and other damages.