Testing for Rezulin Liver Damage

Determining the extent of liver damage due to Rezulin usage depends upon a combination of physical examination, blood tests, and sometimes radiological studies and biopsy.

Common Laboratory Tests

There are several kinds of laboratory tests Rezulin users might undergo to determine the effects of the drug on their liver function, as well as help the physician understand how well Rezulin was performing to control their diabetes. These include:

  • A1c. This test monitors a patient's blood sugar control over the last two months.
  • ALT, (Alanine Aminotranferase). ALT is an enzyme that is found in the blood and its levels increase in conditions where there are damaged or dead liver cells. Determining the amount of ALT in the blood can be an indicator of the extent of liver damage a patient may have.
  • AST, (Aspartate aminotransferase). Much like ALT, AST is an enzyme produced when there is inflammation or conditions of liver damage. Determining the amount of AST in the blood can be an indicator of liver damage.

The results of these tests will help determine how to proceed with alternative blood sugar treatments.

Liver Biopsy

If standard liver function testing is inadequate to determine the cause or scope of damage, a physician may request that the patient have a liver biopsy. The liver biopsy is performed to diagnose what is occurring in a patient's liver and help assess the amount of liver damage for an individual patient. It helps the physician understand how inflamed the liver is, how much scar tissue (cirrhosis) there is, and whether or not a patient has medication-induced liver disease, as in the case of Rezulin. For this testing, a small piece of liver is removed (less than 1/5,000th of the liver). Removing this small piece of liver does not affect liver function.

Before the liver biopsy, a patient may need an ultrasound examination of the liver (a device to visualize the liver using sound waves) to determine the best and safest biopsy site. Please note that not all physicians will order this before a biopsy. Intravenous sedation (sedatives given through the veins) can be given at the patient's request to relax them, but it is important that the patient is partially awake during the biopsy process so the breathing cycle can be held.

Alternatives to the liver biopsy include:

  • No procedure.
  • Laparoscopic surgery. The insertion of a tube into an opening of the abdomen.
  • Radiographic either with CT scan, ultrasound or fluoroscopy.

Rezulin News Timeline

1997
January - Rezulin is approved by the FDA to treat Type II diabetes.
November - The FDA issues a warning about Rezulin (troglitazone). Recommended prescribing information is changed by the drug's manufacturer; new warning label information is added.
December - Approximately 150 adverse events associated with Rezulin have been reported to the FDA.
1998
June - The FDA and Rezulin manufacturer Parke-Davis agree to again tighten restrictions on the use of Rezulin.
July - Parke-Davis sends a letter to heathcare professionals warning to test for liver abnormalities and updating them on the changes in recommended use.
2001
March - Resulin sales are discontinued.

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Last Updated: May 11, 2010. 11:08:49 am.