Supplements & Liver Injury

[Michael Scally MD]

Cases of liver failure linked to diet supplement triple
Cases of liver failure linked to diet supplement triple - Hawaii News Now - KGMB and KHNL

By Lynn Kawano

Update: 10/1:

The number of cases have tripled since the weekend. The State Department of Health confirms, 32 cases of liver failure are now linked to a diet supplement. Since an alert went out state and nationwide, the department has been getting flooded with calls. Most are not related cases but 32 are being investigated by the State and FDA. All the cases are in Hawaii right now.

Update 10:15a.m.:

The State Department of Health now says the number of affected patients in Hawaii is at least ten, up from seven reported on Thursday.

Original story:

Seven people are in Hawaii hospitals suffering from liver failure after taking supplements to lose weight and gain muscle.

The Department of Health sent out an alert to medical professionals nationwide. The letter asks doctors and dietitians to report any patients suffering from liver conditions who were taking supplements.

Of the seven, one had to have a transplant, two others are on the transplant list, and another could be added to the list.

All of the patients were healthy before taking the supplements.

"That's the scary, or worrisome thing, " says State Epidemiologist Sarah Park. "They were previously healthy."

Dr. Park expects the number of cases to grow now that the alert has gone out.

"Seven to ten cases are easy to link in Hawaii," Dr. Park says. "But in larger states, it may be harder."

Dr. Park would not give a specific brand name because she says there could be more than one supplement containing the ingredient in question. She also did not reveal the ingredient, but, Hawaii News Now has learned that the ingredient is found in Oxy Elite Pro, a supplement commonly used by bodybuilders. That company got a letter from Federal Drug Administration last year not because of a link to liver problems. The letter was about the, then, new ingredient it contained.

Dr. Park says the FDA and CDC have now joined the investigation.

 

[pittbox]

Re: OxyElite Pro & Liver Failure

Well that's awesome.
I ran a bottle last summer and still have another.

 

[Gunrunner]

Re: OxyElite Pro & Liver Failure

I wonder if it's the original formula with DMAA or the New Formula without DMAA:

Here is the Original formula:


Here is the New Formula:

 

[pittbox]

Re: OxyElite Pro & Liver Failure

I have the original, made shure I grabbed a few right before the ban.

 

[Pericles]

Re: OxyElite Pro & Liver Failure

I wonder if it's the original formula with DMAA or the New Formula without DMAA:

Here is the Original formula:
View attachment 11547

Here is the New Formula:
View attachment 11548

I had he USP rep in my store the other day, and DMAA has been removed from all of their products. FDA has a hard on for USP.

 

[Pericles]

Re: OxyElite Pro & Liver Failure

I have the original, made shure I grabbed a few right before the ban.

There are many small companies using it. I buy from them, Nitro NCG still has it and is my fav.

 

[Gunrunner]

Re: OxyElite Pro & Liver Failure

I have the original, made shure I grabbed a few right before the ban.

I'm guessing that the original is ok because it has been on the market for a long time with no issues.

 

[Michael Scally MD]

Re: OxyElite Pro & Liver Failure

LIVERTOX provides up-to-date, accurate, and easily accessed information on the diagnosis, cause, frequency, patterns, and management of liver injury attributable to prescription and nonprescription medications, herbals and dietary supplements. Search Livertox Database

LIVERTOX also includes a case registry that will enable scientific analysis and better characterization of the clinical patterns of liver injury.

The LIVERTOX website provides a comprehensive resource for physicians and their patients, and for clinical academicians and researchers who specialize in idiosyncratic drug induced hepatotoxicity.

 

[Pericles]

Re: OxyElite Pro & Liver Failure

I'm guessing that the original is ok because it has been on the market for a long time with no issues.

Original is gone, unless you run across an old bottle. In any event, Nitro NCG is much better than the original OxElite.

Another good product is from Line1 another small company (I buy direct from them, am a friend of the owner who is also a corporate attorney.) http://www.lineonenutrition.com/preworkout_energy_nos_pump_powder.shtml

This product is full of NOS and Creatine, things you don't need if you are on a cycle. Has a solid dose of DMMA.

There were issues w/ DMAA, but because people were idiots, using it as a party drug, drinking alcohol w/ it, and a couple of geniuses did all the aforementioned in the desert w/ dire consequences.

I use it very sparingly. The Nitro dose is 1-3 scoops, but I would never take that much. 2/3rds of a scoop is all I need.

 

[Michael Scally MD]

Re: OxyElite Pro & Liver Failure

I would like to see follow up. Otherwise, I call FOUL.

 

[Michael Scally MD]

Re: OxyElite Pro & Liver Failure

OxyElite Pro isn't the only supplement that the patients took before getting sick. There is at least one other, but the Department of Health won't reveal the name of that supplement.

And it's unclear if an ingredient in the supplements is to blame or a combination of factors.

Dying woman's family says she took diet pills before getting sick
Dying woman's family says she took diet pills before getting sic - Hawaii News Now - KGMB and KHNL

 

[Michael Scally MD]

Re: OxyElite Pro & Liver Failure

Hawaii health officials request removal of diet supplement linked to liver failure
Hawaii health officials request removal of diet supplement linke - Hawaii News Now - KGMB and KHNL

Posted: Oct 08, 2013 1:59 PM CDT
Updated: Oct 08, 2013 3:59 PM CDT

HONOLULU (HawaiiNewsNow) -
The Hawaii State Department of Health (DOH) is alerting local retailers and requesting the voluntary removal from sale of the product OxyElite Pro pending an ongoing investigation of cases of liver failure and acute hepatitis. DOH Food and Drug Branch today began notifying retailers and distributors to voluntarily suspend sales and remove the product from store shelves until further notice. The public is advised to discontinue use of the product at this time.

DOH is currently investigating 29 cases of acute hepatitis and liver failure that have occurred in the state from May through October 2013 and may be related to the use of diet supplements for weight loss and/or muscle building. The cases under investigation include two individuals that have undergone liver transplants and one death.

"Twenty-four cases reported using OxyElite Pro before their illness," said Dr. Sarah Park, State Epidemiologist. "No other supplement or medication has been identified in common among more than two patients."

"The department continues to urge people who use dietary or nutritional supplements for weight loss and/or muscle gain to talk with their doctor or health care provider," said Health Director Loretta Fuddy. "Anyone who develops symptoms such as abdominal pain or discomfort, fatigue, loss of appetite, nausea and /or vomiting, and yellow skin or eyes, should consult their doctor immediately."

DOH is working closely with the U.S. Food and Drug Administration and Centers for Disease Control and Prevention throughout the ongoing investigation.

 

[Michael Scally MD]

Re: OxyElite Pro & Liver Failure

Company pulls diet pills nationwide following Hawaii investigation
Company pulls diet pills nationwide following Hawaii investigati - Hawaii News Now - KGMB and KHNL

Posted: Oct 08, 2013 3:56 PM CDT
Updated: Oct 08, 2013 4:10 PM CDT

HONOLULU (HawaiiNewsNow) -
A representative for a popular diet supplement has notified Hawaii News Now that the company that produces OxyElite Pro is stopping nationwide distribution.

USPlabs says they have no knowledge of any link between their supplements and liver failure, but are doing this voluntarily until the FDA, Hawaii Deptarment of Health, and CDC can figure out the cause.

The Department of Health is currently investigating 29 cases of acute hepatitis and liver failure that have occurred in the state from May through October 2013 and may be related to the use of diet supplements for weight loss and/or muscle building.

The cases under investigation include two individuals that have undergone liver transplants and one death.

Here is the press release from USPlabs:

"The company stands by the safety of all of its products. The company is cooperating with FDA on reports coming out of Hawaii. The cluster of liver issues in Hawaii is a complete mystery and nothing like this has ever been associated with OxyELITE Pro in all of the years our products have been in the market. We know of no credible evidence linking OxyELITE Pro to liver issues. The ingredients have been studied for safety, are consumed in the food supply and widely used in dietary supplements. The studies and consumption history show no negative liver issues. Due to multiple products within the OxyELITE Pro brand, it may be confusing as to which products are being looked at.

The specific products are the original OxyELITE Pro with DMAA, OxyELITE Pro with the "Purple Top" and OxyELITE Pro Super Thermo Powder. The original version with DMAA has not been manufactured or distributed since early 2013. Out of an abundance of caution, the company has ceased domestic distribution of OxyElite Pro with the Purple Top and OxyElite Pro Super Thermo Powder until the investigation has been completed. The company continues to believe these versions are safe and are not the cause of the cluster of liver toxicity that has occurred in Hawaii."

 

[Michael Scally MD]

Re: OxyElite Pro & Liver Failure

OxyElite Pro: Health Advisory - Acute Hepatitis Illness Cases Linked To Product Use
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370857.htm

 

[Michael Scally MD]

Re: OxyElite Pro & Liver Failure

FDA Investigates Acute Hepatitis Illnesses Potentially Linked to Products Labeled OxyElite Pro
http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm370849.htm

October 11, 2013

The U.S. Food and Drug Administration (FDA) continues its investigation of acute hepatitis illnesses linked to products labeled OxyElite Pro.

FDA advises consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1 because these products contain an ingredient, aegeline, for which the manufacturer has not provided adequate evidence of safety.

In a warning letter issued to USP Labs LLC of Dallas Texas on October 11, 2013, the FDA informed the company that the dietary supplements OxyElite Pro and VERSA-1 are deemed to be adulterated, and that failure to immediately cease distribution of these products may result in enforcement action by the FDA.

The warning letter states that the products are deemed adulterated because they contain a new dietary ingredient (an ingredient not previously present in the food supply, and for which there is no history of use or other evidence of safety when used as suggested in the labeling) which lacks adequate information to provide reasonable assurance of safety.

Specifically, USP Labs failed to provide the FDA with evidence, as required by law, that aegeline, also referred to as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide, was safe for use in its dietary supplements.

Additionally, in the warning letter, the FDA relayed findings suggesting that a causal connection may exist between the use of a product labeled as OxyElite Pro and a number of liver illnesses reported in Hawaii.

On October 8, 2013, the FDA posted a statement on its website advising consumers of an ongoing investigation related to a growing number of reports of acute non-viral hepatitis in Hawaii and further advised consumers not to use the dietary supplement product labeled OxyElite Pro while the investigation is still ongoing. Today the FDA is advising consumers not to use an additional product produced by USP Labs labeled VERSA-1.

 

[Michael Scally MD]

Re: OxyElite Pro & Liver Failure

Notes from the Field: Acute Hepatitis and Liver Failure Following the Use of a Dietary Supplement Intended for Weight Loss or Muscle Building — May–October 2013
Notes from the Field: Acute Hepatitis and Liver Failure Following the Use of a Dietary Supplement Intended for Weight Loss or Muscle Building — May–October 2013

Clinicians reported 45 possible cases to the Hawaii DOH in response to a public health alert. Of those, 29 have been identified as cases. The patients have a median age of 33 years (range: 16–66); 14 (48%) were male. The date of first reported laboratory test was used as a proxy for illness onset and ranged from May 10 through October 3, 2013 (Figure). The most commonly reported symptoms included loss of appetite, light-colored stools, dark urine, and jaundice. Median laboratory values reported at the peak of illness were: aspartate aminotransferase 1,128 IU/L (range: 104–2,184, upper limit of normal ~40); alanine transaminase 1,793 IU/L (range: 347–3,091, upper limit of normal ~40); alkaline phosphatase 150 IU/L (range: 68–251, upper limit of normal ~120); and total bilirubin 12.6 mg/dL (range: 2.8–39.6, upper limit of normal ~1.2). Ten patients had liver biopsy data available at the time of this report; seven had histology consistent with hepatitis from drug/toxic injury, with findings including hepatocellular necrosis and cholestasis. Eleven (38%) patients were hospitalized, with a median duration of 7 days (range: 1–45). One patient died, two patients received liver transplants, and two remain hospitalized; all other hospitalized patients have been discharged.

Of the 29 identified patients, 24 (83%) reported using OxyELITE Pro during the 60 days before illness onset. Twelve (41%) reported use of OxyELITE Pro and no other dietary supplement, and 12 (41%) reported use of both OxyELITE Pro and at least one additional dietary supplement. Three (10%) reported using other dietary supplements for weight loss or muscle building, but not OxyELITE Pro. Information about use of OxyELITE Pro is not yet known for two (7%) patients. For twelve patients with specified dates of use, the median duration from starting OxyELITE Pro to the onset of symptoms was 60 days (range: 7–130). There was no other dietary supplement or medication use reported in common by more than two patients.

 

[Michael Scally MD]

Re: OxyElite Pro & Liver Failure

DURBIN CALLS ON DIETARY SUPPLEMENT MANUFACTURER TO PROVE COMPLIANCE WITH FEDERAL LAW REGULATING NEW INGREDIENTS
Durbin Calls on Dietary Supplement Manufacturer to Prove Compliance with Federal Law Regulating New Ingredients - Press Releases - Press Office - U.S. Senator Dick Durbin

[WASHINGTON, D.C.] – U.S. Senator Dick Durbin (D-IL) today called on USPLabs to provide information showing it has complied with federal law requiring dietary supplement manufacturers to report new dietary ingredients and evidence of their safety to the Food and Drug Administration (FDA). In a letter to the CEO and Co-Owner of USPLabs, Durbin raised concerns about OxyElite Pro, a diet supplement that may be linked to 48 cases of liver injury including death. The product contains aegeline – a new ingredient in possible violation of federal law which requires a company to report new dietary ingredients and evidence of their safety to the FDA.

“I am concerned about the mounting evidence that products manufactured by USPLabs endanger consumer health and contain adulterated ingredients,” said Durbin. “The recent cases of adverse events – including liver injury and even death – surrounding yet another USPLabs product raise serious questions about the company’s practices and commitment to consumer safety.”

 

[Gunrunner]

Re: OxyElite Pro & Liver Failure

Acute Hepatitis and Liver Failure Following the Use of a Dietary Supplement Intended for Weight Loss or Muscle Building
Summary
Recently, a number of previously healthy individuals developed acute hepatitis and sudden liver failure of unknown cause after using a dietary supplement for weight loss or muscle building. CDC recommends increased vigilance by public health agencies, emergency departments, and healthcare providers for patients who develop acute hepatitis or liver failure following use of a weight loss or muscle building nutritional supplement. CDC requests that state health departments report such occurrences to the CDC. CDC also recommends that, as part of a comprehensive evaluation, clinicians evaluating patients with acute hepatitis should ask about consumption of dietary supplements.

Background
On September 9, 2013, the Hawaii Department of Health (DOH) was notified of seven patients with severe acute hepatitis and sudden liver failure of unknown cause. The patients were previously healthy and sought medical care from May through September 2013. Clinicians reported that the seven patients had all used OxyELITE Pro, a dietary supplement marketed for weight loss and muscle gain, prior to illness onset.

The investigation is ongoing and the data presented are preliminary. Thus far, clinicians have reported 45 patients to the Hawaii DOH in response to a public health alert. Of those, 29 patients, including the original seven, were confirmed to have acute hepatitis after using a nutritional supplement for weight loss or muscle building. The median age of the 29 patients is 33 years; 14 (48%) are male. The date of the first reported laboratory test was used as a proxy for illness onset and ranged from May 10 through October 3, 2013. The most commonly reported symptoms included loss of appetite, light-colored stools, dark urine, and jaundice. Median laboratory values reported at the peak of illness were the following:

aspartate aminotransferase (AST) 1,128 IU/L;
alanine transaminase (ALT) 1,793 IU/L;
alkaline phosphatase 150 IU/L; and
total bilirubin 12.6 mg/dL.
Ten patients had liver biopsy data available at the time of this report. Seven had histology consistent with hepatitis from drug/toxic injury, with findings including hepatocellular necrosis and cholestasis. Three patients had liver biopsy findings of acute hepatitis associated with other etiologies such as autoimmune hepatitis. Eleven (38%) patients were hospitalized, with a median duration of seven days. One patient died, and two patients received liver transplants. Two remain hospitalized, and all other hospitalized patients have been discharged.

Of the 29 identified patients, 24 (83%) reported using OxyELITE Pro during the 60 days prior to illness onset. There was no other dietary supplement or medication use reported in common by more than two patients.

National case finding efforts have identified several individuals from states outside Hawaii with reported OxyELITE Pro or other weight loss or muscle building dietary supplement use prior to the development of acute hepatitis of unknown cause. CDC, in collaboration with state health departments, is collecting additional clinical and epidemiologic information from these individuals to determine if this outbreak is national in scope.

http://emergency.cdc.gov/HAN/han00356.asp

 

[Pericles]

Re: OxyElite Pro & Liver Failure

I would like to see follow up. Otherwise, I call FOUL.

I have been using Nitro 3 days a week. Normal dosage is 1-3 scoops (according to label) but that is way too much. I do 2/3 rds of a scoop. After work, I am lagging a bit and that dose has me gym ready.

 

[Pericles]

Re: OxyElite Pro & Liver Failure

Acute Hepatitis and Liver Failure Following the Use of a Dietary Supplement Intended for Weight Loss or Muscle Building
Summary
Recently, a number of previously healthy individuals developed acute hepatitis and sudden liver failure of unknown cause after using a dietary supplement for weight loss or muscle building. CDC recommends increased vigilance by public health agencies, emergency departments, and healthcare providers for patients who develop acute hepatitis or liver failure following use of a weight loss or muscle building nutritional supplement. CDC requests that state health departments report such occurrences to the CDC. CDC also recommends that, as part of a comprehensive evaluation, clinicians evaluating patients with acute hepatitis should ask about consumption of dietary supplements.

Background
On September 9, 2013, the Hawaii Department of Health (DOH) was notified of seven patients with severe acute hepatitis and sudden liver failure of unknown cause. The patients were previously healthy and sought medical care from May through September 2013. Clinicians reported that the seven patients had all used OxyELITE Pro, a dietary supplement marketed for weight loss and muscle gain, prior to illness onset.

The investigation is ongoing and the data presented are preliminary. Thus far, clinicians have reported 45 patients to the Hawaii DOH in response to a public health alert. Of those, 29 patients, including the original seven, were confirmed to have acute hepatitis after using a nutritional supplement for weight loss or muscle building. The median age of the 29 patients is 33 years; 14 (48%) are male. The date of the first reported laboratory test was used as a proxy for illness onset and ranged from May 10 through October 3, 2013. The most commonly reported symptoms included loss of appetite, light-colored stools, dark urine, and jaundice. Median laboratory values reported at the peak of illness were the following:

aspartate aminotransferase (AST) 1,128 IU/L;
alanine transaminase (ALT) 1,793 IU/L;
alkaline phosphatase 150 IU/L; and
total bilirubin 12.6 mg/dL.
Ten patients had liver biopsy data available at the time of this report. Seven had histology consistent with hepatitis from drug/toxic injury, with findings including hepatocellular necrosis and cholestasis. Three patients had liver biopsy findings of acute hepatitis associated with other etiologies such as autoimmune hepatitis. Eleven (38%) patients were hospitalized, with a median duration of seven days. One patient died, and two patients received liver transplants. Two remain hospitalized, and all other hospitalized patients have been discharged.

Of the 29 identified patients, 24 (83%) reported using OxyELITE Pro during the 60 days prior to illness onset. There was no other dietary supplement or medication use reported in common by more than two patients.

National case finding efforts have identified several individuals from states outside Hawaii with reported OxyELITE Pro or other weight loss or muscle building dietary supplement use prior to the development of acute hepatitis of unknown cause. CDC, in collaboration with state health departments, is collecting additional clinical and epidemiologic information from these individuals to determine if this outbreak is national in scope.

http://emergency.cdc.gov/HAN/han00356.asp

You do know that these guys were using insane amounts, right? They were also drinking Vodka and were out in the hot sun.

USP labs cited 2 separate studies that concluded that 1,3 is safe if used in reasonable amounts. I would not under any circumstances use it as a party drug, which is what these guys were doing.

I also do not recommend using in hot weather, so summer Cross Fit is out, 2.

I only use it for weight training in an air conditioned gym.