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Item
#12
New Combination Diabetes
Treatment Soon to be Launched
Avandia and metformin in one pill allowing for smaller TZD dose
GlaxoSmithKline hopes to launch its new combination product for
treating diabetes by the end of 2002, the company states. The new
product combines Avandia(R) (rosiglitazone), a member of the
thiazolidinedione class of drugs, and metformin, marketed by
Bristol-Myers Squibb as Glucophage(R).
Avandia has already been approved by the Food and Drug
Administration for treating type 2 diabetes both as a single
therapy and in combination with metformin.
The class of drugs know as thiazolidinediones (TZDs) was tarnished
in 2000 when Rezulin (troglitazone) was withdrawn from the market
because of liver toxicity. According to GSK's CEO, J.P. Garner,
the new Avandia/metformin combination will help restore trust in
TZDs because it allows smaller doses of the TZD.
But Avandia faces a new safety question: whether the product is
safe to use for patients taking insulin. In February 2001, the FDA
added warning statements to the Avandia label regarding kidney and
cardiovascular side effects, but deemed an Avandia/insulin
combination "approvable." Revised labeling, however, includes a
bolded statement that "the use of Avandia in combination with
insulin is not indicated."
The FDA issued a warning letter to GSK in June 2001 for including
conflicting messages regarding Avandia's use with insulin.
Following a "Dear Doctor" letter emphasizing the safety issues,
off-label use of Avandia in combination with insulin fell from
about 10 percent to 2 percent, according to GSK Chief Operating
Officer Bob Ingram.
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