Liver Damage from Medicines, Herbals at Center of New Study
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DRUG-INDUCED LIVER DAMAGE MEDICINE HEPATOXICITY
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Medicines that harm the liver are much in the news these days, from AIDS drugs to heart medications. Now, researchers are seeking people whose livers have been damaged by drugs or herbal remedies, to try to solve the mystery of why this damage happens.



Newswise - Our livers take a lot of punishment every day, coping with the fatty foods, alcohol and tobacco we consume, and filtering toxins from our blood.

But they can't always handle the effects of the medicines and alternative therapies we take for illnesses and ailments. In fact, certain drugs, both prescription and over-the-counter, can inadvertently damage the liver temporarily or even permanently.

Doctors don't fully understand why this happens, or why certain drugs harm the livers of only some people who take them. But they do know that liver toxicity is the top reason why drugs get rejected or pulled from the market by the Food & Drug Administration. And they also know that toxic medication effects are the main cause of sudden, or acute, liver failure in the United States.

Now, the University of Michigan is participating in a new national study that will explore why and how some commonly used drugs and alternative medicines harm the liver, and who is at greatest risk. It's funded by the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health.

The study has just begun enrolling children and adults who have suffered liver damage because of medications. Researchers at U-M and four other sites around the country will study patients with varying types of drug-induced liver injury over time to see how the damage progresses, and to gather information about clinical, genetic and environmental risk factors.

Eight hospitals in southeast Michigan will take part in the U-M's local research network, helping to recruit patients to the study as part of the Michigan Hepatotoxicity Network. Hepatotoxicity is the medical term for liver damage by toxic substances.

Specifically, doctors at the U-M's University Hospital and C.S. Mott Children's Hospital, as well as the Ann Arbor VA Healthcare System, Oakwood Hospital in Dearborn, St. Joseph Mercy Hospital in Ypsilanti, Beaumont Hospital in Royal Oak, Henry Ford Hospital in Detroit and Providence Hospital in Southfield will all take part.

"The study is especially timely given the recent national attention to drug safety and side effects from drugs that have been approved by the FDA," says Robert Fontana, M.D., a U-M liver specialist and co-leader of the national trial.

"The removal of Vioxx and other drugs from the marketplace has raised awareness about the fact that helpful drugs can also have serious drawbacks which don't become apparent until the medication is used by millions of people," says Fontana.

"Although liver toxicity is not the reason that Vioxx was removed, other recent withdrawals including the diabetes drug Rezulin (troglitazone) and the antidepressant Serzone (nefazadone) have been related to liver toxicity. And many more substances, including herbal drugs and weight loss agents, can damage the liver."

The study, called the Drug-Induced Liver Injury Network or DILIN, will have two parts.

One, called the DILI study, will enroll people over the age of 2 years who have recently suffered acute liver problems after taking any drug or herbal therapy. It will exclude patients who have suffered liver damage because of an overdose of acetaminophen, a painkiller often sold under the brand name Tylenol that is well known to cause liver damage in high doses.

Participants in the DILI study will give blood and urine samples for diagnostic and genetic analyses, have an ultrasound scan of their liver, and complete health questionnaires. Participants will be evaluated again six months later, to see if their liver damage is persistent, and if so they'll be contacted annually for follow-up.

The other part of the study, called ILIAD, will seek people over the age of 2 years who in the last 10 years have suffered liver damage due to four specific drugs that are known to pose rare but serious liver risk. The drugs are the anti-tuberculosis drug isoniazid (INH), the anti-seizure drug phenytoin (sold as Dilantin), the combination antibiotic amoxicillin/clavulanate (sold as Augmentin), and the migraine and epilepsy drug valproic acid (sold as Depakote).

All ILIAD participants will have blood drawn and will be interviewed about their experience with the particular drug they took. Their medical records will also be examined. All the data will be entered into a secure registry.

"The DILIN studies are urgently needed because while we know that some drugs can cause severe or even fatal liver damage in some patients, we don't have sufficient information on the underlying clinical, environmental and genetic risk factors that can make someone susceptible," says Fontana, an associate professor of internal medicine at the U-M Medical School and member of the Gastroenterology Division. "We hope we can find some answers, and provide doctors and patients with useful information regarding the potential risk of liver damage from commonly used and otherwise safe medications."

More information on the DILIN study is available at http://www.med.umich.edu/gi/edu/liver2.htm or http://dilin.dcri.duke.edu. People who are interested in research and treatment for drug-induced liver damage may also call the U-M toll-free at 1-866-UM-LIVER.

In addition to Dr. Fontana, who will lead recruitment at the U-M's University Hospital, the Michigan Hepatotoxicity Network includes local lead investigators John Inadomi and Richard Moseley at the Ann Arbor VA, M. James Lopez, at C.S. Mott Children's Hospital, James Sunstrum at Oakwood, Tom Shehab at St. Joseph Mercy, Stuart Gordon at Beaumont, Dilip Moonka at Henry Ford, and Brad Gelzayd at Providence. The study coordinator at U-M is Nadia Tayeh.

The other four lead DILIN research centers are the University of North Carolina, Indiana University, the University of California, San Francisco and the University of Connecticut. Duke University will serve as the DILIN data coordinating center.



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