Home » FDA Announces Recall of Potassium Chloride Capsules Due to Risk of Heart Attacks

FDA Announces Recall of Potassium Chloride Capsules Due to Risk of Heart Attacks

by Richard A Reagan

The FDA has announced a nationwide recall of potassium chloride extended-release capsules due to a risk of heart attacks from improper dissolution. 

Glenmark Pharmaceuticals and American Health Packaging are recalling numerous batches of this critical medication, which could potentially cause dangerously high potassium levels in patients, leading to severe cardiac complications.

The Food and Drug Administration (FDA) has reported that Glenmark Pharmaceuticals is recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, while American Health Packaging is recalling 21 batches of the same medication. 

These capsules are typically prescribed to patients suffering from low potassium levels, or hypokalemia, but the defect could instead precipitate hyperkalemia—a condition characterized by dangerously high potassium levels that can trigger heart attacks and other severe health issues.

According to the FDA’s statement issued on June 25, the defect in the capsules’ dissolution could lead to “irregular heartbeat that can lead to cardiac arrest.” 

The agency has explained the severity of the potential health risks, which range from asymptomatic to life-threatening conditions like cardiac arrhythmias, severe muscle weakness, and even death. However, the FDA also noted that no cases of hyperkalemia or related severe adverse events have been reported so far.

Glenmark Pharmaceuticals has been proactive in addressing the issue, notifying their wholesale and distributor customers through written communications and arranging for the return of all recalled batches. 

Wholesalers, distributors, and retailers have been instructed to halt distribution and initiate a sub-recall to retail or pharmacy customers immediately.

Patients currently using these potassium chloride capsules are advised not to discontinue use without consulting their healthcare provider. 

Those experiencing symptoms of hyperkalemia, which can include palpitations, muscle weakness, or a general feeling of unwellness, should seek immediate medical attention. 

The FDA encourages healthcare providers and patients to report any adverse events related to this recall through their MedWatch Adverse Event Reporting program.

The recall serves as a crucial reminder of the essential role of patient safety in the healthcare industry

Patients affected by this recall should follow the latest guidance from their doctors and stay informed through updates from the FDA.

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