Valsartan

High Blood Pressure

Valsartan is primarily used to treat hypertension (high blood pressure) in adults and children who are at least 6 years old. Lowering high blood pressure helps reduce the risk of serious health issues, such as strokes and heart attacks.

Heart Failure

This medication is used in adults to treat heart failure. It is specifically prescribed to help reduce the risk of hospitalization for patients whose hearts cannot pump blood as well as they should.

Post-Heart Attack Treatment

Valsartan is used in adults who have recently experienced a heart attack (myocardial infarction). In these patients, it is used to improve survival and reduce the likelihood of further heart-related complications.

Combination Use

While valsartan can be used on its own, it is often prescribed in combination with other medications to manage blood pressure. It may be used alongside diuretics (water pills) or other types of heart medications to achieve better results.

Mechanism of Action

Valsartan works by blocking the action of a natural substance in the body called angiotensin II. Angiotensin II is a potent chemical that causes the muscles surrounding blood vessels to contract, which narrows the vessels and increases blood pressure.

By preventing angiotensin II from binding to its receptors, valsartan allows the blood vessels to:

• Relax and widen (dilate).
• Lower the overall blood pressure.
• Improve blood flow throughout the body.

When blood vessels are relaxed, the heart does not have to work as hard to pump blood. This mechanism is beneficial for managing high blood pressure, treating heart failure, and improving survival after a heart attack.

Common Side Effects

Many people using valsartan do not experience significant side effects. When they do occur, common symptoms may include:

• Dizziness or lightheadedness, especially when standing up quickly
• Headache
• Tiredness or fatigue
• Stomach pain or diarrhea
• Back or joint pain
• Cold or flu-like symptoms, such as a sore throat, runny nose, or cough

Serious Side Effects

While less common, some side effects can be serious. Contact a healthcare provider immediately if you experience:

• Signs of high potassium levels, such as muscle weakness or a slow, irregular heartbeat
• Kidney problems, including changes in the amount or frequency of urination
• Severe dizziness or fainting
• Signs of an allergic reaction, such as a rash, itching, or swelling of the face, lips, tongue, or throat
• Difficulty breathing or swallowing

Valsartan can cause serious injury or death to an unborn baby if taken during pregnancy. If you become pregnant while taking this medication, stop use and contact a doctor right away.

Boxed Warning: Fetal Toxicity

Valsartan can cause injury or death to a developing fetus when used during pregnancy. If pregnancy is detected, this medication should be discontinued as soon as possible. It is generally not recommended for use during the second and third trimesters of pregnancy.

Contraindications

Valsartan should not be used by individuals with a known hypersensitivity to any of its ingredients. It is also contraindicated for use in combination with aliskiren in patients who have diabetes.

Low Blood Pressure (Hypotension)

Excessively low blood pressure may occur, particularly in patients who are volume- or salt-depleted due to high-dose diuretics, dietary salt restriction, dialysis, diarrhea, or vomiting. Blood pressure should be monitored closely when starting treatment or increasing the dose.

Kidney Function and Potassium Levels

Changes in kidney function, including acute renal failure, may occur in certain patients, especially those with pre-existing kidney issues or severe heart failure. Additionally, valsartan can cause hyperkalemia (high levels of potassium in the blood). Periodic monitoring of serum creatinine and potassium levels is often recommended, especially for patients with heart failure or kidney impairment.

FDA Recalls and Impurities

The FDA has previously issued recalls for certain batches of valsartan due to the presence of nitrosamine impurities, such as NDMA and NDEA, which are classified as probable human carcinogens. Patients are advised to check with their pharmacist to ensure their specific supply is not affected. It is important not to stop taking the medication without consulting a healthcare provider, as the risks of untreated high blood pressure or heart failure may outweigh the risks of the impurity.

Pregnancy

Valsartan is associated with significant risks when taken during pregnancy, particularly during the second and third trimesters. The medication affects the renin-angiotensin system, which can lead to severe developmental issues or fetal death.

Potential complications for the fetus or newborn include:

• Kidney problems: Reduced renal function or kidney failure.
• Amniotic fluid issues: Low levels of amniotic fluid (oligohydramnios), which can lead to lung underdevelopment and limb deformities.
• Developmental delays: Underdevelopment of the skull (skull hypoplasia).
• Blood pressure issues: Low blood pressure (hypotension) in the infant after birth.

If pregnancy is confirmed, the medication should be stopped as quickly as possible under medical supervision. Individuals planning to become pregnant should discuss alternative blood pressure treatments with their doctor.

Breastfeeding

There is limited information regarding whether valsartan is excreted in human breast milk. Because of the potential for adverse effects on a nursing infant, a decision must be made whether to stop breastfeeding or stop the medication.

Healthcare providers will typically weigh the importance of the drug to the mother against the potential risks to the infant when providing guidance on breastfeeding.

Dosage Forms

Valsartan is provided in forms that are taken by mouth. These include:

• Oral Tablets: The standard form of the medication.
• Oral Solution: A liquid version of the drug.

In addition to being available as a single-ingredient medication, valsartan is also found in combination tablets. These products combine valsartan with other types of blood pressure medications, such as diuretics or calcium channel blockers, to help manage cardiovascular conditions.

FDA Approval and Indications

Valsartan was first approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension (high blood pressure) in adults and children 6 years of age and older. It is also FDA-approved for the treatment of heart failure and to reduce the risk of death following a heart attack in patients with left ventricular dysfunction.

Boxed Warning

Fetal Toxicity: Valsartan carries a boxed warning because it can cause injury or death to a developing fetus. The FDA requires that the medication be discontinued as soon as pregnancy is detected.

Safety Recalls and Impurities

Since 2018, the FDA has issued several safety communications and coordinated voluntary recalls of certain valsartan products. These actions were taken after laboratory testing identified nitrosamine impurities, such as N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), in the active pharmaceutical ingredient supplied by specific manufacturers.

Nitrosamines are classified as probable human carcinogens. The FDA continues to monitor the manufacturing processes of all angiotensin II receptor blockers (ARBs) to ensure they meet safety standards for impurity levels. Not all valsartan products were affected by these recalls, and patients are advised to check with their pharmacist to determine if their specific generic version is subject to any active safety alerts.

Risks of Abrupt Discontinuation

Valsartan is typically prescribed for long-term management of hypertension (high blood pressure) or heart failure. Stopping the medication without medical guidance can lead to several complications:

• Rebound Hypertension: Your blood pressure may rise quickly to levels higher than they were before you started treatment. This sudden increase can put significant strain on your heart and blood vessels.
• Increased Cardiovascular Risk: A rapid spike in blood pressure increases the risk of serious events, including heart attack or stroke.
• Worsening Heart Failure Symptoms: If you are taking valsartan for heart failure, stopping it may cause a return of symptoms such as difficulty breathing, extreme tiredness, or swelling in the legs and ankles.

Medical Supervision

It is essential to continue taking valsartan even if you feel healthy, as high blood pressure often has no visible symptoms. If your doctor decides you should stop taking this medication, they may recommend a gradual reduction in dosage or immediately start you on a different treatment to ensure your condition remains stable.

If you experience bothersome side effects, contact your healthcare provider to discuss alternatives rather than stopping the medication on your own. If you miss a dose, take it as soon as you remember, unless it is nearly time for your next scheduled dose. Do not double the dose to make up for a missed one.