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FDA Warning for Diet Pill OxyElite Pro

Published on Oct 15, 2013 at 3:31 pm in Dangerous Drugs.

The dietary supplement OxyElite Pro has been linked to cases of acute hepatitis and liver failure. In early October, the U.S. Food and Drug Administration (FDA) issued an advisory cautioning people to stop using any supplement labeled OxyElite Pro.

The supplement, distributed by USPlabs in Texas, is a diet pill marketed to target body fat. The product is sold throughout the U.S. via Internet and retail sellers.

The problem surfaced when 29 cases of acute non-viral hepatitis were reported in Hawaii. Twenty-four of those patients had been using the OxyElite Pro product. Eleven of the patients were hospitalized, two received liver transplants, and one died. An investigation to confirm causation is underway, but the Hawaii state epidemiologist said that no other supplement or medication has been found in common among more than two of the affected patients.

Symptoms

The diet pill was sold throughout the U.S., but the known recent cases that are suspected to have a link to OxyElite Pro occurred in Hawaii. The Centers for Disease Control and Prevention (CDC) is currently investigating other reports of liver damage throughout the country.

Symptoms of non-viral hepatitis are consistent with all types of hepatitis. According to the FDA MedWatch, the symptoms can include “fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes, and jaundice.”

The distributor, USPlabs, issued a statement claiming that it stands by its product, and that it is cooperating with the FDA’s investigation.