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FDA cracks down on weight-loss supplement


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Reporting that it contains an antidepressant, the U.S. Food and Drug Administration since Feb. 28 has been urging consumers “not to purchase or use” a weight-loss supplement previously linked to liver damage. The supplement is called Oxy Elite Pro Super Thermogenic. The agency learned in its laboratory analysis that a particular lot of the product contained fluoxetine, the generic selective serotonin reuptake inhibitor sold under the brand name Prozac.

Prozac is used for treating depression, bulimia, obsessive-compulsive disorder (OCD), panic disorder, and premenstrual dysphonic disorder (PMDD).

The FDA came right out and wrote about the risks associated with SSRIs. As the agency’s February 2015 statement reads, “Uses of SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis), ventricular arrhythmia or sudden death can occur.”

This was not the only year in which the FDA has dealt with Oxy Elite Pro.

Prodded by the FDA, the manufacturer of Oxy Elite Pro, USPlabs LLC, announced in late 2013 that it would recall certain Oxy Elite Pro products and destroy warehouse stocks of the supplement that would have retailed for about $22 million combined. Adverse event reports triggered the FDA’s response.

“As soon as we suspected a possible link between Oxy Elite Pro products and cases of liver failure and non-viral hepatitis in Hawaii, we warned the public and immediately launched an investigation with state officials and the Centers for Disease Control and Prevention,” FDA Dietary Supplement Division Director Dr. Daniel Fabricant said. “Our mandate to protect the public was fulfilled by ensuring the swift removal of the product from the marketplace.”

The problem in 2013 was not generic Prozac. Back then, the FDA nailed the manufacturer for the presence of two other ingredients that were not necessarily safe.

The FDA said that it warned the manufacturer in October 2013 that certain Oxy Elite Pro products as well as another supplement known as VERSA-1 contained aegeline, “for which the company did not provide evidence of safety.” Earlier in 2013, according to the FDA, another load of Oxy Elite Pro had to be destroyed because it contained DMAA, or dimethylamylamine, which the agency said “can cause high blood pressure and lead to heart attacks, seizures, psychiatric disorders and death.”

“Twice in a short period, this company has added new dietary ingredients to supplements without notifying the FDA and providing a reasonable expectation of safety, as required by law,” Fabricant explained. “Losses to the company should also serve as a reminder that FDA’s laws and regulations serve a purpose and must be followed.”

As for a recently enacted law that empowered the FDA to take these actions against the Oxy Elite manufacturer, Fabricant said, “The new law provided us new tools to act when a potential hazard is introduced to the market. The goal, however, is to prevent these things from happening. Companies must realize there are consequences for their actions, and consumers can help by exercising caution.”

There is obviously a regulatory process at work here that is intended to pursue justice for the people as a whole, in the interest of public health. And there is also a judicial process through which justice for the victims may be obtained. The product liability attorneys at Reich & Binstock have been taking on drug makers for 30 years, and they have the expertise that a victim of a drug-related injury can count on.

If you believe that you have been injured by the use of a medication or supplement, contact Reich & Binstock for a free consultation. The law firm operates in all 50 states, so your state of residency is not an issue in obtaining the aggressive and thorough legal representation that you deserve.

Contact Reich & Binstock either by calling the toll-free number below or by submitting an electronic message through its website.

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