Although news from 97 , should apply still. Seems intersting and a case for someone starting trials to be accepted in Canada & US. Diabetes is on the rise, for what reason I don't know, but it seems you hear of people having Type II and having difficulty controlling it. The side effects of Rezulin, do not sound very good.
New York Times and Wall Street Journal report on potential
liver-damage problems associated with Type II Diabetes drug "Rezulin"
The New York Times reported November 3, 1997 that the U.S. Food and Drug
Administration said that Rezulin might cause liver damage. Rezulin is an insulin-sensitizer
that has been marketed in the United States since January, 1997.
The Times noted: "The company [Warner-Lambert Company] has changed the labeling on
the drug following 35 reports of liver injury - ranging from mildly elevated levels of certain
enzymes to two cases of liver failure, one resulting in a transplant, one in death."
The Times stated that the FDA said that it is not known whether the drug was solely
responsible for all 35 reports of liver injury. "But," the Times continued, "the Parke-Davis
unit of Warner, which manufactures and markets Rezulin, has issued new product inserts
stating that patients taking the drug should have periodic blood test to monitor liver
enzymes. Patients with elevated liver enzymes must stop taking the drug."
A report in the Wall Street Journal, November 4, 1997, noted that while Rezulin got off to a
fast start in the U.S. and has generated sales of $242 million through the third quarter of
this year, "...the drug outlook is now cloudier because the new information adds additional
risk and cost considerations for diabetes patients."
The Wall Street Journal reported that, according to the FDA, "Based on clinical trials,
approximately 2% of the patients on Rezulin can be expected to have to stop taking the
drug because of elevated liver enzymes."
The Journal also reported that a letter dated October 31 was mailed to 300,000 doctors and
12,000 other health-care professionals, reporting the instances of liver problems and
recommending that doctors check patients' liver enzyme levels periodically with a blood
test.
The Wall Street Journal noted, "The rate of liver problems reported so far among the
patients taking the drug since its introduction is much lower [than in the clinical trials of the
drug], at less than 1%. But a Warner-Lambert spokesman said more reports may surface
following the letter sent to doctors."
BiOTECH's Type II Diabetes drug, trade-marked as DIAB II, can also be described as an
insulin sensitizer though its mechanism of action is different from drugs classed as
glitazones, such as Rezulin. Diab II has been sold as a prescription drug since January
1997 in one market, China. DIAB II appears to be a remarkably benign drug. Laboratory
and animal trials did not indicate any mutagenicity or carcinogenicity. Testing indicated no
toxicity in doses up to 10,000 times the therapeutic dosage. In clinical trials of DIAB II
preceding regulatory approval, there were no adverse side-effects distinguishable from
placebo. Ongoing patient use of DIAB II has not led to any reports of toxicity. |
