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Troglitizone (Rezulin) Modifications Addressed
In the past several weeks, troglitizone (Rezulin, Parke- Davis) has received negative media attention regarding reports of liver damage and associated fatalities. Misinformation included that at least 26 deaths have been associated with troglitizone and that it was being withdrawn from the market. The impetus for this recent attention seems to rest with a consumer group called Public Citizen, who has petitioned Parke-Davis to remove troglitizone. Public Citizen defends itıs position pointing to: that in June, The National Institutes of Health discontinued it's troglitizone study due to one case of liver failure that led to a liver transplant and an eventual death and in December, troglitizone was withdrawn from the marker in the United Kingdom.
Parke-Davis responds by providing the information that, to date, there are 14 confirmed deaths in the United States associated with troglitizone. And during clinical trials in North America, 48 of 2510 (1.9%) troglitizone treated patients and 3 of 475 (0.6%) placebo treated patients developed ALT levels greater than 3 times the upper limit of normal.
Troglitizone treats insulin resistance, an underlying pathology of type 2 diabetes. It has been shown to improve glucose uptake and utilization in skeletal muscle and adipose tissue and inhibits hepatic production of glucose. It is indicated as an adjunct to diet and exercise to lower blood sugar in patients with type 2 diabetes.
Parke-Davis has modified their recommendations for liver enzyme monitoring. The modifications are more stringent and are intended to "reduce the risk of rare but serious liver injury, including liver failure leading to transplant or death". Originally,the liver enzyme monitoring recommendations were implemented in November of 1997 and Parke-Davis indicates that the very few hepatocellular events reported may have been due to the lack of recommended monitoring .
Modifications include:
~ Patients with moderately elevated ALT levels at the start of therapy (greater than 1.5 times the upper limit of normal) should not be initiated on Rezulin therapy.
~ ALT levels should be measured at the start of Rezulin therapy and monthly for 8 months, then every 2 months for the remainder of the first year of therapy and periodically thereafter.
~ Patients whose ALT levels are found to be moderately elevated (greater than 1.5-2 times the upper limit of normal) during Rezulin therapy should have ALT levels retested within a week and then weekly until they either return to normal levels or rise above 3 times the upper limit of normal, at which point Rezulin should be discontinued.
The American Diabetes Association (ADA) supports trogitizone and the FDA evaluation division by saying, "there are clear benefits to using this drug in appropriately selected and monitored patients."
Parke-Davis encourages health care providers to report any adverse event to 1-800-223-0432 or to the FDA Med Watch program at 1(800)FDA-1088. Contact your Parke Davis pharmaceutical representative for
education material about Rezulin or to respond to any questions or concerns.
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