Glenmark recalls 114 batches of low potassium drug in the US over potentially deadly hyperkalemia risk

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来源: FiercePharma

To date, Glenmark says it hasn’t received any reports of elevated potassium levels or serious side effect reports linked to the recall.

While patients with low potassium often need medication to boost levels of the electrolyte in the body, too much of a good thing can cause serious health concerns.

Glenmark Pharmaceuticals on Tuesday said it’s recalling 114 batches of 750mg potassium chloride extended-release capsules thanks to failed dissolution of the product.

Failed dissolution of the capsules could cause patients to develop heightened potassium levels, also known as hyperkalemia, which can result in irregular heartbeat. That side effect can potentially in turn lead to cardiac arrest.

Glenmark’s potassium chloride capsules are used to treat patients with low potassium, or hypokalemia. For patients who consistently use the drug—and especially in those with other underlying health conditions like hypertension, heart failure or kidney dysfunction—there is a “reasonable probably of developing hyperkalemia that may lead to a range of severity of adverse events,” including those that are potentially life-threatening, Glenmark said in a release.

To date, Glenmark says it hasn’t received any reports of elevated potassium levels or serious side effect reports linked to the recall. The company is performing the product pull voluntarily in conjunction with the FDA.

The suspect batches of potassium chloride capsules were shipped out across the U.S. to wholesalers, distributors and retailers, Glenmark said. The lots in question were set to expire between June 2024 and September 2025.

The recall comes a little less than a year after Glenmark extricated itself from a sticky debt situation.

Last September, the Mumbai, India-based company revealed plans to extinguish its debt by pawning off 75% of its active pharmaceutical ingredient (API) business to Nirma Limited for Rs 5,651 crore ($681 million).

At the time, Glenmark’s chairman and managing director Glenn Saldanha said the company was facing a gross debt of approximately Rs 4,600 crore ($555 million).

Elsewhere, the threat of hyperkalemia has forced other recalls in the past.

Back in March of 2021, generic drugmaker Alembic Pharmaceuticals yanked one lot of 20mg telmisartan tablets for hypertension in the U.S. due to a complaint that a single 30-count bottle with a 20mg label instead contained 40mg tablets.

Patients who received a double dose of the hypertension med over a prolonged period of time could suffer low blood pressure, worsening kidney function or a potentially life-threatening elevation of potassium levels, Alembic warned at the time.

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