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Hepatitis C Bulletin: Beware of Eltrombopag!

Nicole Cutler L.Ac. May 24, 2010

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Although eltrombopag may help some people complete Hepatitis C therapy and thus beat the virus, learn why the FDA is warning physicians that this platelet-boosting drug poses a risk to those with chronic liver disease.

Following the latest news updates on medications that you have been or could be prescribed is a monumental and often frustrating task. This is especially true for those living with chronic Hepatitis C, since new developments related to this illness seem to emerge on a daily basis. A recent report from the U.S. Food and Drug Administration (FDA) has delivered news that ranks high on the priority list of things those with Hepatitis C should be aware of. In collaboration with the FDA, GlaxoSmithKline unveiled important information about the platelet-boosting drug eltrombopag (Promacta), specific to individuals with liver disease.

What Is Eltrombopag?

To help those with a blood-clotting problem, eltrombopag is a medication that increases the production of platelets. Other drugs that can restore normal platelet functions are infusions or injections, while eltrombopag has the advantage of being a pill taken just once a day.

Irregularly-shaped, colorless cells that are present in blood, platelets have a sticky surface that helps them form clots to stop bleeding. This function is necessary, because the human body does not handle excessive blood loss well. Thus, individuals who have low levels of platelets in their blood run a substantial risk of a dangerous bleed. There are a handful of conditions that could lead to low platelet levels. Because it is one of the most severe side effects of ribavirin, a low platelet count is the most prominent reason for discontinuing Hepatitis C combination therapy (pegylated interferon and ribavirin).

Eltrombopag Used for Hepatitis C

Following a 2007 study by Duke University Medical Center researchers, eltrombopag has been a medication preferred by some hepatologists for certain individuals with Hepatitis C. According to the study involving Duke and other centers worldwide, eltrombopag was found to boost platelet levels of a majority of patients with low platelet counts and cirrhosis of the liver due to Hepatitis C infection.

Completing the fully prescribed course of Hepatitis C combination therapy offers those with this liver disease the most hope for recovery. Unfortunately, many must discontinue Hepatitis C treatment because of its severe side effects. By capitalizing on the platelet-boosting action of eltrombopag, patients with low platelet counts were deemed eligible for beginning or continuing Hepatitis C combination therapy – giving them a better chance of eliminating the virus.

The Eltrombopag Warning

Despite the appearance of eltrombopag being a savior for many people trying to complete Hepatitis C treatment, a new safety finding reveals just the opposite. Upon this discovery, the FDA has begun notifying healthcare professionals to be aware of eltrombopag increasing the likelihood of a venous thrombus in those with chronic liver disease. Also known as a blood clot in a vein, a venous thrombus located in deep veins is a major risk for a pulmonary embolism – a potentially fatal event. Although the study revealing this trend was small, there was a clear tendency to forming venous blood clots in participants who took eltrombopag compared to those taking a placebo. While GlaxoSmithKline is working with regulatory agencies to include more specific safety information on eltrombopag’s label, here is what you should know:

  • Eltrombopag should be aimed at increasing the platelet count to a level that reduces the risk of bleeding – not for bringing the platelet count up to normal.
  • Additional caution should be exercised when administering eltrombopag to those with Hepatitis C, including lower dosages and monitoring the patient closely.

Any course of therapy must carefully weigh potential risks with the possible benefits. When it comes to fighting Hepatitis C, this analysis gets complicated, especially if managing low platelet counts during antiviral therapy. Your healthcare provider should be aware of this new warning by the FDA. However, we are always our own best advocates, so make sure you know about the potential risk of using eltrombopag during Hepatitis C therapy.

References:

http://www.docguide.com/news/content.nsf/news/852576140048867C8525772100737C12, FDA Warns Against Eltrombopag Use in Patients With Chronic Liver Disease, Retrieved May 17, 2010, Doctor’s Guide Publishing Limited, 2010.

http://www.drugs.com/mtm/eltrombopag.html, eltrombopag, Retrieved May 19, 2010, drugs.com, 2010.

http://www.fi.edu/learn/heart/blood/platelet.html, Platelets: Sticky Situations, Retrieved May 19, 2010, The Franklin Institute, 2010.

http://www.saudijgastro.com/article.asp?issn=1319-3767;year=2010;volume=16;issue=1;spage=51;epage=56;aulast=Danish, Considerations in the management of hepatitis C virus-related thrombocytopenia with eltrombopag, Fazal A Danish, et al, Retrieved May 17, 2010, The Saudi Journal of Gastroenterology, January 2010.

http://www.sciencedaily.com/releases/2007/11/071128172408.htm, Pill Boosts Platelets In Hepatitis C Patients, Retrieved May 17, 2010, ScienceDaily LLC, 2010.

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