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| Wayne Parsons Law Offices

Revised and updated – Dietary supplements made the news in Hawaii this week and USPlab’s OxyELITE Pro is being blamed for acute liver failures and other serious medical conditions in Hawaii residents. In the best analysis of the Hawaii cases that I have found, Anne Andrews who respresents victims of DMAA, reviews the Hawaii situation in her article OxyELITE Pro Linked to Liver Failure Outbreak in Hawaii . She explains:

The Hawaiian Department of Health (DOH) just announced an acute heptatitis and liver failure outbreak linked to USPlab’s OxyELITE Pro and other dietary supplements for weight loss and/or muscle gain.  Originally, 7 cases were reported, but that number has now skyrocketed to 32. Sufferers are experiencing symptoms from acute hepatitis to liver failure, and many are being evaluated for liver transplants.  So far, all reported cases are from Hawaii.

People who have suffered acute liver failure may have to undergo liver transplants to survive, and getting a liver transplant is a difficult process that takes time. Doctor Linda Wong, M.D. at the Queens Medical Center is heading up a team of liver surgeons attempting to deal with the large number of seriously ill patients who have been brought to Queens in serious condition. The numbers are still rising. If you or a loved one took a dietary supplement and are not feeling well go to the Emergency Room, preferrably at Queens, or your family doctor. The liver is a crucial organ.

Although Hawaii seems to be the largest and most recent cluster of cases, national health experts and the Food & Drug Administration (FDA) have been focusing on the problem for the past year. As reported on KHON Hawaii News Now:

Officials with the State Department of Health say more cases were reported by concerned medical professionals after an alert went out statewide and nationwide last week.

There were 7 original cases but HNN sources say that number has gone up significantly since the weekend.   They range from acute hepatitis to complete liver failure.  At least one patient has already had a transplant, several more are on the list for a transplant and many more are being evaluated.

What’s so shocking to the medical community is how quickly the patients’ health declined.  According to the State Epidemiologist Dr. Sarah Park,  they were all healthy, adults who were trying to lose weight or gain muscle.

The New York Times reported on these health risks of products like OxyELITE PRO and Jack3d in April: F.D.A. Issues Warning on Workout Supplement,  and  Published: April 12, 2013:

Certain workout-booster and fat-burning products, sold in recent years by retailers like GNC and Vitamin Shoppe, are illegal and may present serious health hazards to consumers, federal health regulators have determined.

William P. O’Donnell/The New York Times

The fitness supplement Jack3d contains DMAA.

With names like Jack3d and OxyElite Pro, the popular products contain a stimulant known as dimethylamylamine, or DMAA for short. In a public warning late Thursday, the Food and Drug Administration said that the stimulant did not qualify as a legal dietary supplement ingredient and that it could raise blood pressure, potentially causing heart attacks and other health problems.

Since early 2008, the agency has received reports of 86 health problems, including at least five deaths, in consumers who used DMAA products. Although such reports do not prove that the stimulant directly caused the health problems, agency officials warned people not to consume the ingredient.

The leading law firm litigating these cases on the mainland is Andrews & Thornton from Irvine, California.  Their history of representing persons injured by these dietary supplements gives them the latest information on the cause of the illnesses, the treatments available and the legal rigfhts of their clients. Anne Andrews explains that these supplements can cause the following conditions:

The Most Serious DMAA Side Effects Include:

  • Death
  • Heart Attack
  • Cardiac Arrest
  • Heat Stroke
  • Seizure
  • Kidney Failure
  • Rhabdomyolysis
  • Liver Failure
  • Loss of consciousness
  • Heart palpitations

Troubling questions about the manufacturing of these dietary supplemnts have been circulating for over a year. On December 4, 2012 the FDA sent a Warning Letter to USPlabs, LLC in dallas Texas which stated in part:

From February 7 through 21, 2012, the U.S. Food and Drug Administration (FDA) inspected your facility located at the above-referenced address. During the inspection, our investigators evaluated the manufacturing of several of your products, which you label as dietary supplements, including Jack3d, OxyElite Pro, and Super Cissus.

In addition to the inspection, our investigators reviewed the labeling for your products found on your website in October 2012. Based on our review, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and the referenced regulations through links on FDA’s homepage at www.fda.gov1.

In a July 16, 2013 FDA article: DMAA in Dietary Supplementsit was noted thayt many of the products were off the market.But the cluster of cases in Hawaii continues to grow. It could be that the concerns raised by the FDA about the manufacturing lapses at the companies have resulted in defective formulations.

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