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Possibly Safer Diabetes Drugs Pose Threat to Rezulin

January 02, 2008 | 1,833 views

Type II diabetes affects 15 million Americans and can lead to devastating complications such as blindness, limb amputations and nerve damage. Drug makers SmithKline Beecham Plc (SB.L) and Eli Lilly & Co. (LLY.N) are expected to shake up the U.S. diabetes market this year with safer new medicines against the most common form of the disease, threatening Warner-Lambert Co.'s (WLA.N) controversial drug Rezulin. Rezulin (troglitazone), launched in early 1997 and generating 1998 U.S. sales of $748 million, could soon face stiff competition from SmithKline's planned entrant, Avandia (rosiglitazone), and Eli Lilly's product, Actos (pioglitazone).

Both of the newcomers are awaiting approval from the U.S. Food and Drug Administration and could become blockbusters with annual sales of more than $1 billion. All three drugs are members of a new (thiazolidinedione) class of oral drugs against Type II diabetes, which typically strikes in adulthood and is closely linked to obesity. They work by improving the ability of the body's insulin to remove glucose from the bloodstream. Older standard drugs fight the disease by increasing the amount of insulin made in the pancreas or by reducing the amount of sugar made by the liver.

More than 1.4 million Americans have taken Rezulin since it was introduced in 1997. But its sales have been crimped by concerns over dozens of U.S. patient deaths linked to the drug, which can cause severe liver toxicity. On March 26, an FDA advisory panel will publicly review Rezulin's safety record in the wake of highly critical ABC and CBS television reports about the pill. Patients taking Rezulin must receive periodic blood tests to monitor for elevated levels of liver enzymes, a marker for liver damage.

COMMENT: Nearly all diabetics will go into remission with a low grain diet. The Heller’s book (which is currently between printings and not available) The Carbohydrate Addict Lifespan Program does an excellent job of detailing the program. One can use the book in conjunction with my food recommendations in The Basics on my home page at One can also go to the Heller’s web site which is the first link on my Links page on my web site.

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