First introduced under the brand name Diovan, the blood pressure medicine valsartan is now available from more than 30 different companies in its generic form. The FDA announced a recall for some generic batches of the drug in July 2018 because of N-nitrosodimethylamine (NDMA) contamination. This was followed by additional recalls of medications containing valsartan, losartan and irbesartan.
Valsartan is a type of blood pressure drug called an angiotensin II receptor blocker (ARB). Other drugs in the valsartan drug class include irbesartan (Avapro), losartan (Cozaar), and candesartan (Atacand).
Novartis manufactured the first brand-name valsartan drug, Diovan, and the U.S. Food and Drug Administration approved it in 1996. Novartis lost its patent in 2012, and generic manufacturers began producing and distributing the drug.
Doctors prescribe valsartan to treat high blood pressure, congestive heart failure and heart attack. Valsartan may also improve the chances of living longer when prescribed to patients who have problems with the heart’s left ventricle following a heart attack.
The FDA announced a generic valsartan recall in July 2018 because it found a cancer-causing chemical called N-nitrosodimethylamine (NDMA) in some batches. Now, some people who took the tainted drugs are filing valsartan lawsuits.
How Does Valsartan Work?
Valsartan blocks the angiotensin II receptor. Angiotensin II is a hormone produced in the body that can cause blood vessels to narrow, raising blood pressure.
By blocking the angiotensin II receptor, the drug keeps blood vessels from narrowing. This lowers blood pressure and improves blood flow.
What Are Side Effects of the Drug Valsartan?
The most common valsartan side effects include headache, nausea and dizziness. Less common but more serious side effects include allergic reactions and reduced kidney function.
Valsartan Brand Name
After Novartis lost its patent for Diovan in 2012, valsartan became available as a generic drug. Dozens of generic valsartan manufacturers, distributors and repackagers provide the United States with its supply of the drug.
- Exforge (in combination with Amlodipine, a molecule that lowers blood pressure)
- Entresto (in combination with Sacubitril, a molecule that lowers blood pressure)
- Byvalson (in combination with Nebivolol, a molecule that lowers blood pressure)
Valsartan vs Losartan
A 2001 study in Clinical Therapeutics found valsartan and losartan similarly effective in reducing blood pressure in patients with mild to moderate hypertension.
Losartan was also associated with a decrease in serum uric acid levels. Valsartan did not decrease those levels. High levels of uric acid are associated with gout.
Valsartan vs Lisinopril
A study in Clinical Therapeutics in 2004 found both valsartan and lisinopril highly effective in controlling blood pressure in patients with mild to severe hypertension. But valsartan was associated with significantly fewer adverse events, especially cough.
Precautions and Warnings for Valsartan
The American College of Cardiology says you should tell your doctor before taking valsartan if you have kidney, liver or heart disease, or if you are dehydrated. Women who are or may be pregnant should not take the drug.
Using valsartan and alcohol is not recommended. Do not use valsartan with potassium supplements or a salt substitute unless your doctor has told you to do so.
Patients with liver disease should exercise care when taking valsartan, according to the drug’s label. The label does not mention valsartan and grapefruit.
Black Box Warning for Valsartan
Valsartan does include a black box warning for fetal toxicity. It indicates pregnant women should not use valsartan. The drug can cause injury or death to the developing fetus.
If women become pregnant they should stop using valsartan right away.
In 2018, the FDA warned that manufacturers found unacceptable amounts of the chemical N-nitrosodimethylamine (NDMA) in some batches of generic valsartan. The toxic chemical may have been present in the drugs for as long as four years. The agency provided a list of products included in the valsartan recall.
Several companies recalled batches of valsartan because of contamination with the suspected cancer-causing chemical. Lawyers are now investigating and filing valsartan lawsuits for people who took tainted medication. Unacceptable amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), N-Nitrosodiethylamine (NDEA) and NDMA were also found in other generics that contain losartan and irbesartan, which resulted in more recalls.
How to Take Valsartan
Take valsartan as prescribed for the dose and time directed. You should take the drug at the same time each day.
You can take it with or without food. Store the drug at room temperature. Keep it away from heat and moisture.
If you miss a dose, take it as soon as you remember. If it’s close to your next dose, just take the one dose. Do not take extra valsartan to offset a missed dose.
The usual starting dose in valsartan tablets is 80 mg or 160 mg once daily, according to the drug’s label. A doctor may increase the dosage after one to two weeks of therapy. The maximum dosage is one 320 mg tablet once daily as needed to control blood pressure in adults.
- Valsartan 40 mg
- Valsartan 80 mg
- Valsartan 160 mg
- Valsartan 320 mg (maximum dosage)
Valsartan Combination Drugs
A doctor may prescribe drugs that combine valsartan with other active ingredients to lower blood pressure. These formulas include valsartan and hydrochlorothiazide (HCTZ) and amlodipine, valsartan and hydrochlorothiazide (HCTZ).
If you overdose on valsartan, seek immediate, emergency medical help. You can also call the poison help line at 1-800-222-1222.
Possible symptoms of an overdose include fast or slow heartbeat. People who overdose on valsartan may feel dizzy or like they might pass out.
Valsartan Drug Interactions
Valsartan interacts with a number of drugs. Be sure to tell your doctor about any prescriptions, over-the-counter-medications and supplements you’re taking.
- Certain diuretics
- Nonsteroidal anti-inflammatory drugs such as aspirin, ibuprofen, naproxen, celecoxib, diclofenac, indomethacin or meloxicam
Please seek the advice of a medical professional before making health care decisions.