Showing posts with label Liver Injury Dietary Supplements. Show all posts
Showing posts with label Liver Injury Dietary Supplements. Show all posts

Wednesday, October 24, 2018

'The food supplement that ruined my liver'

BBC
'The food supplement that ruined my liver'
Tristan Quinn
It should have been one of the happiest days of his life. But Jim McCants looks back on his youngest son's high school graduation with mixed emotions. As he sat down next to his wife Cathleen in the university auditorium, just outside Dallas, Texas, she turned to look at him.

"She said 'Do you feel OK?'" Jim recalls. "I said, 'Yeah I feel fine, why?' 'Your face is yellow, your eyes are yellow, you look terrible.' When I looked in the mirror it was shocking."
Read More: https://www.bbc.com/news/stories-45971416

On This Blog
Current articles investigating herbal and dietary supplement-induced liver injury 

Friday, October 12, 2018

Dietary Supplements Can Contain Viagra, Steroids, or Worse

In Case You Missed It
How Many Cases of Drug-Induced Liver Injury Are Caused by Herbal and Dietary Supplements?
September 2018
Herbal and dietary supplement-induced liver injury is more severe than other types of drug-induced liver injury (DILI), and re-exposure is more likely, researchers report in the September issue of Clinical Gastroenterology and Hepatology. Increasing awareness of the hepatoxic effects of herbal and dietary supplements could help physicians make earlier diagnoses
Read more

In The News - Wired 
You know those sexual enhancement dietary supplements for sale at gas stations and markets across the country? Beware, they might actually be viagra. Or steroids. Or an antidepressant. Many supposed dietary supplements for weight loss, erectile dysfunction, and muscle building may contain actual pharmaceuticals—but you likely have no way of knowing what's in them.

Between 2007 and 2016, the FDA issued warnings about unapproved pharmaceutical ingredients in 776 dietary supplements, according to a new report in JAMA Network Open. Of those, less than half received voluntary recalls. The authors compiled their data from the FDA’s own warning website. Known as the Tainted Products Marketed as Supplements List, it catalogs any time the FDA reports finding unapproved pharmaceutical ingredients in supplements. The hundreds of offending supplements the FDA found during that nine-year period traced back to 146 companies. These represent only a small fraction of the potentially hazardous supplements on the market.


JAMA - Original Investigation 
Public Health
October 12, 2018
Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings
Jenna Tucker, MPH1,2,3; Tessa Fischer, DVM, MPH2,3; Laurence Upjohn, PharmD3; et al David Mazzera, PhD3; Madhur Kumar, MS, PhD3
Key Points Question
What are the trends across adulterated dietary supplements associated with a warning released by the US Food and Drug Administration from 2007 through 2016?

Findings
In this quality improvement study, analysis of the US Food and Drug Administration warnings from 2007 through 2016 showed that unapproved pharmaceutical ingredients were identified in 776 dietary supplements, and these products were commonly marketed for sexual enhancement, weight loss, or muscle building. The most common adulterants were sildenafil for sexual enhancement supplements, sibutramine for weight loss supplements, and synthetic steroids or steroid-like ingredients for muscle building supplements, with 157 products (20.2%) containing more than 1 unapproved ingredient.

Meaning
Potentially harmful active pharmaceuticals continue to be identified in over-the-counter dietary supplements.

Abstract
Importance Over half of adults in the United States report consuming dietary supplements. The US Food and Drug Administration (FDA) has warned of numerous dietary supplements containing undeclared, unapproved pharmaceutical ingredients. These FDA warnings have not been comprehensively analyzed for recent years.

Objective 
To summarize trends across adulterated (containing unapproved ingredients) dietary supplements associated with a warning released by the FDA from 2007 through 2016.

Design, Setting, and Participants In this quality improvement study, data were extracted from the FDA’s Center for Drug Evaluation and Research, Tainted Products Marketed as Dietary Supplements_CDER database from 2007 through 2016. Data from each warning were recorded unless multiple warnings were issued for the same product within a 6-month period. Date, product name, company, hidden ingredient(s), product category, source of sample, and warning document type were recorded for each included warning. Data analysis was conducted from February 2017 to June 2017.

Results
From 2007 through 2016, 776 adulterated dietary supplements were identified by the FDA and 146 different dietary supplement companies were implicated. Most of these products were marketed for sexual enhancement (353 [45.5%]), weight loss (317 [40.9%]), or muscle building (92 [11.9%]), with 157 adulterated products (20.2%) containing more than 1 unapproved ingredient. The most common adulterants were sildenafil for sexual enhancement supplements (166 of 353 [47.0%]), sibutramine for weight loss supplements (269 of 317 [84.9%]), and synthetic steroids or steroid-like ingredients for muscle building supplements (82 of 92 [89.1%]). There were 28 products named in 2 or 3 warnings more than 6 months apart. Of these products, 19 (67.9%) were reported to contain new unapproved ingredients in the second or third warning, consistent with the assumption that the FDA found the product to be adulterated more than once. In recent years (2014-2016), 117 of 303 adulterated samples (38.6%) were identified through online sampling and 104 of 303 (34.3%) were identified through the examination of international mail shipments.

Conclusions and Relevance
Active pharmaceuticals continue to be identified in dietary supplements, especially those marketed for sexual enhancement or weight loss, even after FDA warnings. The drug ingredients in these dietary supplements have the potential to cause serious adverse health effects owing to accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other pharmaceuticals within the supplement.
Full-text: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2706496

Invited Commentary
JAMA Network
2018;1(6):e183329. doi:10.1001/jamanetworkopen.2018.3329
The FDA and Adulterated Supplements 
Pieter A. Cohen, MD1,2
The US Food and Drug Administration (FDA) plays an essential role in ensuring the safety of vitamins, minerals, botanicals, probiotics, amino acids, and glandular extracts sold as dietary supplements in the United States. While the FDA does not assess the safety of supplements prior to market, the agency is tasked with identifying and removing adulterated and hazardous supplements from the marketplace.

Adulteration of dietary supplements typically involves 1 of 2 patterns: economic adulteration, in which a less expensive ingredient is used in place of a more expensive ingredient listed on the label, or pharmaceutical adulteration, in which an active drug is included in a purportedly botanical supplement, for example, sildenafil in a “natural” sexual enhancement supplement. The FDA maintains a public database listing the brands of supplements it has identified as adulterated with drugs and the actions, if any, it has taken to remove the product from commerce.

An analysis of the FDA database of pharmaceutically adulterated supplements is the focus of a new study by Tucker and colleagues.1 The authors found that between 2007 and 2016 the FDA identified 746 brands of supplements adulterated with pharmaceutical agents. The adulterants included prescription medications such as sildenafil and fluoxetine, withdrawn medications including sibutramine and phenolphthalein, and unapproved drugs including dapoxetine and designer steroids. Twenty percent of the adulterated supplements contained 2 or more undeclared drugs, for example, weight loss supplements containing both an anorectic and a laxative. Most supplements adulterated with drugs were marketed as weight loss, sexual enhancement, or sports supplements—the same categories that epidemiologists have found to be responsible for a disproportionate number of the estimated 23 000 emergency department visits attributed to dietary supplements each year in the United States.2

Given the potential public health risks of inadvertently ingesting unknown quantities of pharmaceutical drugs, once an adulterated supplement has been identified by the FDA, the agency frequently requests that the responsible firm voluntarily recall the product and, if the firm agrees, the agency publicizes the recall through email alerts and postings on its website. However, the effectiveness of voluntary recalls for supplements has been questioned.3,4 In one study, investigators found that many supplements previously subject to recalls remained on sale and were still adulterated with pharmaceutical drugs, sometimes years after the initial recall.3 In another study, consumers of a supplement subject to a voluntary recall were not aware of the recall and continued to purchase the product following the recall.4

Despite their limited effectiveness, voluntary recalls are the most common approach used by the FDA to remove adulterated supplements from commerce. In the current study, the agency discovered 746 distinct supplements to be adulterated but announced voluntary recalls for only 360. Only 360 of 746 (48%) were recalled, leaving the majority of adulterated supplements, more than 350 products, available for sale.

The database does not provide information as to why the FDA fulfilled its responsibilities less than half of the time, but it is possible that some firms might have refused to voluntarily recall their products. Warning letters may be used to nudge firms to recall supplements. In the current study, however, more than 140 firms were involved, but the FDA issued only 7 warning letters. The agency has other enforcement tools at its disposal when a firm does not agree to a voluntary recall, including mandating a recall (authority available since 2011 under the FDA Food Safety Modernization Act) or making a referral to the Department of Justice. Tucker and colleagues1 found that the agency seldom uses these enforcement tools: the FDA reported no mandatory recalls and only 1 Department of Justice investigation in response to the 746 brands of adulterated supplements.

This new evidence is consistent with prior research that has highlighted major deficiencies in the FDA’s regulation of supplements. In a similar study published in 2013, Harel and colleagues5 found that the FDA identified 332 brands of supplements adulterated with pharmaceutical agents during the 9-year period from 2004 to 2012 but only 222 brands (67%) were recalled.5 In another investigation from 2013, the FDA’s analytical chemists uncovered a mixture of synthetic compounds, including an amphetamine analog, β-methylphenylethylamine (BMPEA), in weight loss and sports supplements.6 The FDA did not inform consumers or issue warning letters. An independent study describing the FDA’s inaction was published 2 years later,7 and only then did the FDA begin to take steps to remove the supplements containing BMPEA from the market.

This pattern is currently repeating itself—the FDA has not warned consumers about additional stimulants discovered in weight loss and sports supplements. My colleagues and I informed the FDA in early 2017 that we had identified 2 experimental stimulants, 1,4-dimethylamylamine and octodrine, in dietary supplements.8 One stimulant has never been approved by the FDA for use in humans, and the other was approved for use by inhalation in the 1940s but has since been removed from the US market. Neither stimulant has ever been FDA approved for oral consumption. Our research has since been confirmed by FDA-funded investigators,9 yet as of September 2018 the FDA has not taken any regulatory action to remove these synthetic stimulants from commerce or warn consumers about the novel adulterants.

To counter the perception of regulatory inertia, FDA officials have emphasized their work to eliminate the stimulant 1,3-dimethylamylamine (1,3-DMAA) from supplements. The sympathomimetic 1,3-DMAA was originally introduced by Eli Lilly & Co in the 1940s as a nasal decongestant to compete with amphetamine marketed by Smith, Kline and French.10 By the 1970s, 1,3-DMAA had been withdrawn from the US markets, but it reappeared in the 2000s as a replacement for ephedra in sports and weight loss supplements; by 2012 the stimulant was available in more than 200 brands of supplements.10 The World Anti-Doping Agency banned the stimulant in sport in 2009. In 2011, Health Canada banned 1,3-DMAA from supplements and the US Department of Defense removed 1,3-DMAA supplements from military bases due to safety concerns. The stimulant received prominent media attention as potentially contributing to strokes and deaths of US troops. Only in 2012 did the FDA finally begin to use its full enforcement powers, including warning letters, product seizures, and mandatory recalls, to remove the stimulant from supplements.

More than FDA action will be required to ensure that all adulterated supplements are effectively and swiftly removed from the market. Congress would need to reform the Dietary Supplement Health and Education Act of 1994. One practical change would be to require firms to register supplements with the FDA prior to sale and Congress could provide the FDA with more effective enforcement tools such as immediately revoking a product’s registration if a supplement is found to be adulterated with pharmaceutical drugs. In the meantime, the process that the FDA is required to follow to remove supplements from the marketplace will remain cumbersome and time-consuming; nevertheless, the agency’s failure to aggressively use all available tools to remove pharmaceutically adulterated supplements from commerce leaves consumers’ health at risk.

Article Information
Published: October 12, 2018. doi:10.1001/jamanetworkopen.2018.3329

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2018 Cohen PA. JAMA Network Open.

Tuesday, September 18, 2018

How Many Cases of Drug-Induced Liver Injury Are Caused by Herbal and Dietary Supplements?

AGA Journals 

Kristine Novak
Herbal and dietary supplement-induced liver injury is more severe than other types of drug-induced liver injury (DILI), and re-exposure is more likely, researchers report in the September issue of Clinical Gastroenterology and Hepatology

Increasing awareness of the hepatoxic effects of herbal and dietary supplements could help physicians make earlier diagnoses and reduce the risk of serious liver damage.

About the Author 
Dr. Kristine Novak is the science editor for Gastroenterology and Clinical Gastroenterology and Hepatology. She has worked as an editor at biomedical research journals and as a science writer for 15 years, covering advances in gastroenterology, hepatology, cancer, immunology, biotechnology, molecular genetics, and clinical trials. She has a PhD in cell biology and an interest in all areas of medical research.

Thursday, April 19, 2018

European Food Safety Authority Warns Green Tea Extracts May Be Associated With Liver Damage

According to new research from the European Food Safety Authority (EFSA) consuming more than 800mg of green tea catechins per day may lead to higher health risks, including liver damage.

Scientific opinion on the safety of green tea catechins EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)
Maged Younes Peter Aggett Fernando Aguilar Riccardo Crebelli Birgit Dusemund Metka Filipič Maria Jose Frutos Pierre Galtier David Gott Ursula Gundert‐Remy Claude Lambré Jean‐Charles Leblanc Inger Therese Lillegaard Peter Moldeus Alicja Mortensen Agneta Oskarsson Ivan Stankovic Ine Waalkens‐Berendsen Rudolf Antonius Woutersen Raul J Andrade Cristina Fortes Pasquale Mosesso Patrizia Restani Davide Arcella Fabiola Pizzo Camilla Smeraldi Matthew Wright

First published: 18 April 2018 https://doi.org/10.2903/j.efsa.2018.5239

Full-Text

Abstract
The EFSA ANS Panel was asked to provide a scientific opinion on the safety of green tea catechins from dietary sources including preparations such as food supplements and infusions. Green tea is produced from the leaves of Camellia sinensis (L.) Kuntze, without fermentation, which prevents the oxidation of polyphenolic components. Most of the polyphenols in green tea are catechins. The Panel considered the possible association between the consumption of (‐)‐epigallocatechin‐3‐gallate (EGCG), the most relevant catechin in green tea, and hepatotoxicity. This scientific opinion is based on published scientific literature, including interventional studies, monographs and reports by national and international authorities and data received following a public ‘Call for data’. The mean daily intake of EGCG resulting from the consumption of green tea infusions ranges from 90 to 300 mg/day while exposure by high‐level consumers is estimated to be up to 866 mg EGCG/day, in the adult population in the EU. Food supplements containing green tea catechins provide a daily dose of EGCG in the range of 5–1,000 mg/day, for adult population. The Panel concluded that catechins from green tea infusion, prepared in a traditional way, and reconstituted drinks with an equivalent composition to traditional green tea infusions, are in general considered to be safe according to the presumption of safety approach provided the intake corresponds to reported intakes in European Member States. However, rare cases of liver injury have been reported after consumption of green tea infusions, most probably due to an idiosyncratic reaction. Based on the available data on the potential adverse effects of green tea catechins on the liver, the Panel concluded that there is evidence from interventional clinical trials that intake of doses equal or above 800 mg EGCG/day taken as a food supplement has been shown to induce a statistically significant increase of serum transaminases in treated subjects compared to control.


In The Media
Green tea supplements may cause liver damage, warns EU watchdog
The European Food Safety Authority assessed the safety of the supplements
More than 800mg of green tea catechins each day may pose health concerns
Officials at the EU funded organisation were unable to confirm a safe dose
It today called for further scientific trials into the effect of green tea catechins

Wednesday, February 28, 2018

Journal, and patient blog updates - Beyond one virus: vaccination against hepatitis B after hepatitis C treatment.

Read the latest journal and viral hepatitis updates from patient bloggers who work hard to educate and inspire us all.

HCV Advocate
HCV Advocate has just published their Monthly Newsletter, check out the latest "March issue."

News
Forbes
Judy Stone
Given the experience in Indiana, which saw a spike in STDs, Hepatitis C and HIV, Walensky expects the HIV/Hepatitis C to “go up in lock-step with those” other sexually transmitted diseases. Walensky raised interesting points regarding HIV medications as well, noting “In the past 2-3 years, the cost of first line antiretroviral ...

Gilead Sciences Canada, Inc. (Gilead Canada) today recognizes the Ontario Ministry of Health and Long-Term Care for its leadership in the expansion of access to therapies that treat chronic hepatitis C virus infection under the Ontario Drug Benefit (ODB) Program. Today, all eligible ODB recipients will have greater access to treatment, regardless of the severity of disease (fibrosis level), to achieve a cure and improve their quality of life. Patients with chronic hepatitis C will no longer have to wait for their disease to progress before starting treatment.

Specialty Pharmacy Times
A study published by Clinical Infectious Diseases suggests that screening all adults for HCV may be cost-effective and could also identify more patients with the infection than current recommendations.

In The Journals
Lancet
Volume 18, No. 3, p246–247, March 2018
New treatments for hepatitis C virus (HCV) infection with direct-acting antivirals provide an extraordinary cure rate. A recent Article by Xavier Forns and colleagues1 shows an outstanding 99% sustained virological response among all viral genotypes.

NIH
Developing a universal influenza vaccine — a vaccine that can provide durable protection for all age groups against multiple influenza strains, including those that might cause a pandemic — is a priority for the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Writing in the Journal of Infectious Diseases, NIAID officials detail the Institute’s new strategic plan for addressing the research areas essential to creating a safe and effective universal influenza vaccine. They describe the scientific goals that will be supported to advance influenza vaccine development. The strategic plan builds upon a workshop NIAID convened in June 2017 that gathered scientists from academia, industry and government who developed criteria for defining a universal influenza vaccine, identified knowledge gaps, and delineated research strategies for addressing those gaps.

Journal Of Hepatology
«The times they are a’changin’» – Positioning the European Association for the Study of the Liver in the changing landscape of hepatology
Bob Dylan’s words hold relevance for several forces currently acting upon hepatology and the European Association for the Study of the Liver (EASL). The arrival of direct-acting antivirals, which marked the definitive transformation of hepatitis C virus infection into a curable disease with a new focus on public health represents only one of the changes. Fuelled by demographic changes of an ageing population, by migration movements in and beyond Europe, as well as by lifestyle changes and the explosion of the metabolic syndrome, other areas are in rapid expansion. The most pronounced of which are related to non-alcoholic fatty liver disease (NAFLD), hepatitis B virus infection, alcoholic disease and hepatocellular carcinoma (HCC). Moreover, tremendous dynamics in science and drug development now offer treatment options for patients with rare diseases that are also increasing in prevalence. Major trends at the societal level also have an impact on EASL.

Healio
Foster GR, et al. Hepatol. 2018;doi:10.1002/hep.29852.
February 27, 2018
Zepatier demonstrated high efficacy among patients with hepatitis C genotype 3, regardless of treatment experience or baseline resistance-associated substitutions, according to recently published data.

Healio Gastroenterology
Feature
Ira M. Jacobson, MD
The field of hepatology has seen revolutionary changes occuring within hepatitis C therapy over the past few years. This extraordinary newfound ability to cure almost all patients with chronic HCV raises many questions about clinical outcomes.

“Herbal and dietary supplement-induced liver injury is an increasing healthcare problem,” Lucena said. “The present study is a comprehensive analysis of all HILI cases reported to the Spanish DILI Registry to date. This study provides relevant information about clinical features associated with HILI, and highlights the importance of identifying all medicinal products, prescription drugs as well as herbal and dietary supplement products, taken by patients who develop liver abnormalities.”

Of Interest @ Healio
By some estimates, there are between 50,000 and 200,000 apps intended to serve a medical need. These apps claim to manage symptoms of depression, improve care in patients with irritable bowel disease, manage diabetes as well as help patients with a myriad of other medical uses.

HepCBC
Read today's news or a nice summary of notable headlines published in the latest issue of "The Weekly Bull."

Hepatitis B
AGA Blog
Gastroenterology and Clinical Gastroenterology and Hepatology.
Dr. Kristine Novak
NVR3–778, a capsid assembly modulator, reduces serum levels of hepatitis B virus (HBV) DNA and HBV RNA in mice with humanized livers and stable HBV infection, researchers report in the February issue of Gastroenterology. The combination of NVR3–778 and interferon prevented viral replication and HBV RNA particle production to a greater extent than....

Hep B Blog
Hepatitis B Foundation
February 28, 2018
Welcome to “Journey to the Cure” This is a web series that chronicles the progress at the Hepatitis B Foundation and Baruch S. Blumberg Institute towards finding the cure for hepatitis B.

Hepatitis C
CHERISH
In a recent publication in Clinical Infectious Diseases, CHERISH trainee Dr. Shashi Kapadia, CHERISH staff member Philip Jeng, CHERISH director Dr. Bruce Schackman and CHERISH research affiliate Dr. Yuhua Bao characterize variation in DAA utilization among states and explore the association between changes in Medicaid treatment eligibility criteria and trends in DAA utilization.

Life Beyond Hep C
Connie M. Welch
Hep C Patient John, shares his conquering story from hepatitis C, end stage liver disease, liver cancer and liver transplant. Connie: John, Thank you for being with us this week and sharing your awesome story of how you’ve come through this battle with liver disease.

Hep Blogs
By Connie M. Welch 
February 28, 2018 
The guiding principle of the national transplant system has been; locals first. Most organs stay in the areas where they are donated, even if sicker patients are waiting in other parts of the country.

Hep - Forums 
Welcome to the Hep Forums, a round-the-clock discussion area for people who have Hepatitis B, C or a co-infection, their friends and family and others with questions about hepatitis and liver health. Check in frequently to read what others have to say, post your comments, and hopefully learn more about how you can reach your own health goals.

HepatitisC.net
By Kimberly Morgan Bossley
February 27, 2018
Working has always been my “thing” you can say. I started very young and have never not had a job or career. During the Spring of 2005, I was running three individual companies. All...

By Daryl Luster
February 26, 2018
Yes I know, a sensational title. I apologize for the dramatic tone. The thing is that we are inclined to do this bracing thing in preparation for storms, difficult events, or things...

By Kimberly Morgan Bossley
February 23, 2018
Stop complaining about your situation and start doing things to change it. How many times have we all heard this through our journey in life? I know for myself growing up it...

HepatitisC.net - Forums
Talk about it - privately
Have questions? Want to talk about Hep C? Connect with others privately in our forums!

HIV
Nature Blogs
Amy Maxmen
Several vaccines and drugs for preventing the spread of HIV are showing signs of success in clinical trials, three decades after scientists began the search. But some researchers fear that progress will stall without a coordinated strategy to ensure that the most promising therapies to prevent infection win support from policymakers and reach the people who need them.

NAM 
The new edition of "HIV update is now online."
Untreated hepatitis C can cause serious liver disease, including fibrosis (a build-up of fibrous scar tissue, leading to a ‘stiff’ liver) and cirrhosis (serious scarring that blocks blood flow through the liver, kills liver cells and interferes with liver function). The more advanced the fibrosis and cirrhosis, the greater the risk of serious illness and death. Successful hepatitis C treatment can clear the virus from the body. But less is known about its long-term impact on fibrosis or cirrhosis.

Women and Viral Hepatitis
Healio
A systematic review and meta-analysis revealed that maternal viral load among mothers with hepatitis B was a significant risk factor for mother-to-child transmission, and was dose-dependent with HBV transmission incidence.

Rates of hepatitis C infections are on the rise among adults in the United States, and some of those adults are pregnant women.

Healthy You
Scope
Stanford Medicine 
February 26, 2018
There's a wide debate surrounding the use of antidepressants. Do they really work? If so, how well? And how do you know which one to select?

Harvard Health
Christopher Bullock, MD, Carolyn A. Bernstein, MD, FAHS
Getting regular exercise is one of the best actions you can take to improve or maintain your overall health. Fitting exercise into your life is not as difficult as it might seem, but it does require some planning.

Also @ Harvard Health - Diet and depression

NHS
Tuesday February 27 2018
A new UK study investigated levels of inappropriate antibiotic prescribing by GPs in England. This was defined as prescribing antibiotics where guidelines say they're of little to no benefit.

Thanks for stopping by.
Tina

Friday, February 9, 2018

Herbal assault: liver toxicity of herbal and dietary supplements

DOI: https://doi.org/10.1016/S2468-1253(18)30011-6

Editorial
Herbal assault: liver toxicity of herbal and dietary supplements
The Lancet Gastroenterology & Hepatology
Published: March 2018

Download PDF

The worldwide market for herbal and dietary supplements is booming. Even actress Gwyneth Paltrow's lifestyle company Goop has got in on the action, pedalling quirkily named supplements like “Balls in the air” and “The mother load”, targeted at those working at an “intense pace” and expectant mothers, respectively. These supplements promise to revitalise, replenish, and reinvigorate, in part via proprietary blends of herbal extracts. But the health benefits of such products are largely unsubstantiated by scientific data, and they are increasingly associated with harmful side-effects, including liver toxicity.

Tuesday, January 9, 2018

Healio - Herbal, dietary supplement-induced liver injury more common in young women


Herbal, dietary supplement-induced liver injury more common in young women
Medina-Cáliz I, et al. Clin Gastroenterol Hepatol. 2017;doi:10.1016/j.cgh.2017.12.051.
January 9, 2018

Analysis of the Spanish Drug-Induced Liver Injury registry showed that cases of herbal and dietary supplement-induced liver injury were more common in young women than older patients or men and correlated with hepatocellular injury and high levels of transaminases.

“Herbal and dietary supplement-induced liver injury is an increasing healthcare problem,” Inmaculada Medina-Cáliz, PhD, from the University of Málaga, Spain, and colleagues wrote. “In contrast to medicinal products including Traditional Herbal Medicinal Products which are regulated in the European Union with regard to efficacy, safety and quality standards, the lack of regulation of ‘natural’ dietary supplemental products, together with the limited awareness of physicians and consumers about possible harmful effects of these supplements, reflect the need for research and reporting in this field.”

Friday, October 20, 2017

The Liver Meeting® 2017 - The Frequency of Herbal and Dietary Supplement Mislabeling

Updates On This Blog
The Liver Meeting® 2017


Herbal and dietary supplements often mislabeled
Last Updated: 2017-10-24
By Megan Brooks
NEW YORK (Reuters Health) - Product information on labels of most herbal and dietary supplements are inaccurate, according to research presented at The Liver Meeting, held by the American Association for the Study of Liver Diseases.

Products used for body building and weight loss are most apt to be mislabeled, Dr. Victor Navarro from Einstein Healthcare Network in Philadelphia, and his colleagues found.

They did a chemical analysis of 203 herbal and dietary supplements (HDS) and compared the results to ingredients listed on the product labels.

Fewer than half of the products (90 of 203, 44%) had labels that accurately reflected their contents.
Based on the composition of the product, mislabeling occurred in 80% of products made principally of steroidal ingredients, 54% of those made principally of vitamin ingredients, and 48% of those made largely of botanical ingredients, the researchers say.

Products intended for bodybuilding, weight loss, energy boosters and general health/well-being had mislabeling rates of 79%, 72%, 60% and 51%, respectively.

Similar mislabeling rates were found the 166 HDS products judged to be responsible for liver injury by investigators with the Drug Induced Liver Injury Network (DILIN).

"What is novel in terms of actually testing products, is the extent of the mislabeling of over-the-counter supplements, which translates into significant health risks for consumers taking them," Samantha Heller, registered dietitian and senior clinical nutritionist, NYU Langone Health, told Reuters Health by email.

"There are a high number of cases of liver injury due to dietary supplements that include hepatotoxicity, acute liver failure and subsequent death or transplantation, as well as nephrotoxicity," said Heller, who was not involved in the study.

Heller said the message is clear. "Don't bother taking any dietary supplement that claims to promote fast weight loss, build muscle, detox or cleanse the body, boost brain power, cure disease or offer other miraculous results. At this time there is no scientific evidence to support any of these claims. Consumers' money is better spent on a fitness center membership, seeing a registered dietitian for evidence-based nutritional guidance, adopting healthy lifestyle habits, and getting a massage."
The study had no funding, and the authors have no relevant disclosures.
SOURCE: http://bit.ly/2uxPeI1
American Association for the Study of Liver Diseases 2017.
Reuters Health - Read the article (LINK)

Most dietary supplements mislabeled, may cause liver injury
October 22, 2017
WASHINGTON — Mislabeling or omission of ingredients occurs frequently in herbal and dietary supplements, especially among bodybuilding and weight loss products, according to a presentation at The Liver Meeting 2017. “We have found that the dietary supplements are a common cause of liver injury,” Victor J. Navarro, MD, from the department of transplantation at the Einstein Healthcare Network, Philadelphia, said in his presentation. “In looking at those cases, we find that there are a lot of products that are difficult to identify exactly what they are and what they’re used for. There has been a lot of literature that tells us that dietary supplements in the market can be mislabeled and can be adulterated.”
Article available @ Healio

The Frequency of Herbal and Dietary Supplement Mislabeling
Washington, D.C. – Herbal and dietary supplement mislabeling is common and should be evaluated as a potential cause for liver damage, according to research presented this week at The Liver Meeting® — held by the American Association for the Study of Liver Diseases.

The herbal and dietary supplements industry is a multi‐billion‐dollar‐per‐year enterprise in the United States. Over 20 percent of cases of liver injury reported to the U.S. Drug Induced Liver Injury Network (called DILIN) are attributed to herbal and dietary supplements.

“Since herbal and dietary supplements are not required by the FDA to be tested for safety or effectiveness, the DILIN has focused on various factors that could explain their potential for harm,” says Victor Navarro, MD, chair of Hepatology for Einstein Medical Center in Philadelphia.

There is a growing concern that potentially mislabeled products may contain ingredients that can be highly toxic, and damaging, to the liver. To assess this, Dr. Navarro’s team of researchers used samples of herbal and dietary supplements collected by DILIN to analyze the contents of these products and determine the frequency of mislabeling.

Between 2003 and March 2016, DILIN collected 341 herbal and dietary supplement products from 1,268 patients enrolled in DILIN. The National Center for Natural Products Research at the University of Mississippi conducted a chemical analysis on 229 of these products. The ingredients, as they were determined by the chemical analysis, where then compared to the ingredients listed on the 203 analyzed products that contained a label.

As determined through the chemical analysis, Dr. Navarro’s team found only 90 of 203 products contained labels that accurately reflected their contents. Mislabeling – defined by the researchers as when the chemical analysis did not confirm the ingredients listed on the label – occurred in 80 percent of products used for body building and performance enhancement, and 72 percent of products used for weight loss. “Based on these findings, the DILIN will embark upon a more detailed analysis of the chemical ingredients, to determine the precise cause of the liver injury”.

Dr. Navarro will present these findings at AASLD’s press conference in Room 103B at the Walter E. Washington Convention Center in Washington, D.C on Saturday, October 21 at 4 PM. Dr. Navarro will present the study entitled “The Frequency of Herbal and Dietary Supplement Mislabeling: Experience of the Drug Induced Liver Injury Network” on Tuesday, October 24 at 10:15 AM in the Ballroom. The corresponding abstract (264) can be found in the journal, HEPATOLOGY (link is external).

About AASLD
AASLD is a medical subspecialty society representing clinicians and researchers in liver disease. The work of our members has laid the foundation for the development of drugs used to treat patients with viral hepatitis. Access to care and support of liver disease research are at the center of AASLD’s advocacy efforts.

AASLD is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease. AASLD was founded in 1950 by a small group of leading liver specialists and has grown to an international society responsible for all aspects of hepatology.

Press releases and additional information about AASLD are available online at www.aasld.org.