Is Bempedoic acid approved by the FDA?

Yes, bempedoic acid, marketed under the brand name Nexletol, is FDA approved. The U.S. Food and Drug Administration (FDA) approved bempedoic acid on February 21, 2020. This medication offers a novel approach to lowering cholesterol levels and reducing the risk of heart-related events for adults with certain conditions.

What is Bempedoic Acid?

Bempedoic acid is an oral tablet used to manage high cholesterol levels. It is specifically indicated for:

• Lowering the risk of heart attack and heart procedures (e.g., stent placement or bypass surgery) in adults with known heart disease or those at high risk for heart disease who are not taking statins.
• Reducing low-density lipoprotein (LDL) cholesterol in adults with primary hyperlipidemia, including those with heterozygous familial hypercholesterolemia (HeFH).

Bempedoic acid works by inhibiting an enzyme called adenosine triphosphate-citrate lyase (ACL), which plays a crucial role in cholesterol production in the liver.

Usage and Dosage

Bempedoic acid is available as Nexletol, in the form of 180 mg oral tablets. The recommended dosage is one tablet per day, which can be taken with or without food. It is typically used in conjunction with dietary changes and possibly other cholesterol-lowering medications.

Side Effects

While bempedoic acid is generally well tolerated, it can cause some side effects, including:

• Common cold symptoms
• Back pain
• Stomach pain
• High uric acid levels, which can lead to gout
• Increased liver enzymes
• Muscle spasms
• Anemia
• Bronchitis

Serious Side Effects

Bempedoic acid may cause serious side effects such as:

• Increased Uric Acid Levels: This can lead to hyperuricemia and gout. Symptoms include severe foot pain, warm joints, swelling, and redness.
• Tendon Rupture or Injury: The risk is higher in individuals over 60, those taking corticosteroids or fluoroquinolones, and those with renal failure or previous tendon issues. Symptoms include pain, swelling, and difficulty moving the affected area.

Warnings and Precautions

Before taking bempedoic acid, it is essential to inform your healthcare provider of any medical conditions, especially if you have a history of gout, tendon problems, severe kidney or liver issues, or if you are pregnant or breastfeeding.

Conclusion

Bempedoic acid (Nexletol) is a valuable FDA-approved option for individuals needing additional cholesterol management and risk reduction for heart disease, especially for those who are unable to take statins. Approved on February 21, 2020, it provides an effective solution for lowering LDL cholesterol levels and helping to prevent heart attacks and other heart procedures.

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