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FDA Alerts On Compounded Vitamin Capsules Distributed By Glades Drugs


The U.S. Food and Drug Administration has alerted health care professionals and patients of a voluntary recall of compounded multivitamin capsules containing high amounts of Vitamin D3 (Cholecalciferol), distributed nationwide by Glades Drugs in Pahokee, Florida.

FDA has received reports of several adverse events potentially associated with these compounded capsules made by Glades Drugs.

According to the regulator, consumption of this product may result in vitamin D toxicity. This may be severe and may lead to life-threatening outcomes if left untreated.

Patients suffering adverse effects from high Vitamin D levels may not initially show symptoms. Hence, patients who have received these compounded capsules should stop taking this medication and immediately seek medical attention.

Symptoms of short-term vitamin D toxicity, also known as hypercalcemia, are due to high calcium levels and include confusion, increased urination, increased thirst, loss of appetite, vomiting, and muscle weakness.

Acute hypercalcemia may intensify tendencies for heart arrhythmias and seizures and may increase the effects of certain heart drugs.

Long-term toxicity may cause kidney failure, increase in calcium deposits in the blood and soft tissue, bone demineralization and pain. Patients with conditions such as liver disease or chronic kidney failure may be at increased risk for developing vitamin D toxicity.

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