Glenmark recalls 114 batches of low potassium drug in US due to deadly hyperkalemia risk

Glenmark Pharmaceuticals has announced the recall of 114 batches of its 750mg potassium chloride extended-release capsules due to failed dissolution. The dissolution failure could lead to heightened potassium levels in patients, a condition known as hyperkalemia. This condition is particularly dangerous as it can cause irregular heartbeats and, in severe cases, cardiac arrest.

Potassium chloride capsules are typically prescribed to treat hypokalemia or low potassium levels in the body. For patients who rely on this medication, particularly those with existing medical conditions such as hypertension, heart failure, or kidney dysfunction, the risk of developing hyperkalemia is notable. According to Glenmark, the continuous use of these capsules under these circumstances could lead to adverse events ranging from mild to potentially life-threatening.

Despite these risks, Glenmark has not received any reports of elevated potassium levels or serious side effects linked to this recall. The company has decided to recall the product voluntarily, working in collaboration with the U.S. Food and Drug Administration (FDA). The affected batches were distributed nationwide to wholesalers, distributors, and retailers, with expiration dates ranging from June 2024 to September 2025.

This recall follows a period of financial recovery for Glenmark. Less than a year ago, the Mumbai-based company managed to alleviate a significant debt burden. In September, Glenmark sold 75% of its active pharmaceutical ingredient (API) business to Nirma Limited for Rs 5,651 crore ($681 million). At the time, Glenmark's gross debt stood at approximately Rs 4,600 crore ($555 million), according to its chairman and managing director, Glenn Saldanha.

The risk of hyperkalemia has necessitated recalls in the pharmaceutical industry before. For example, in March 2021, Alembic Pharmaceuticals recalled one lot of 20mg telmisartan tablets, a medication for hypertension. A labeling error resulted in 40mg tablets being packaged in bottles labeled as 20mg. Prolonged use of this incorrect dosage could lead to low blood pressure, worsening kidney function, and elevated potassium levels, posing significant health risks.

Glenmark's decision to recall the potassium chloride capsules underscores the importance of drug safety and quality control. The potential for serious health issues due to medication errors or product failures is a constant concern in the pharmaceutical industry. By taking proactive measures and working closely with regulatory bodies, companies can mitigate risks and protect patient health.

In conclusion, Glenmark Pharmaceuticals is recalling numerous batches of their potassium chloride capsules due to dissolution issues that pose a significant risk of hyperkalemia. While no adverse effects have been reported so far, the voluntary recall highlights the company's commitment to patient safety and regulatory compliance. This action also draws attention to the broader issue of drug safety in the pharmaceutical sector, emphasizing the need for rigorous quality control and swift response to potential health risks.