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 Rezuin Recall-The Facts Rezulin Basics


The Rezulin Recall

On March 21, 2000 the head of the FDA's Center for Drug Evaluation and Research stated that the "Continued use of Rezulin" posed an "unacceptable risk " to diabetes patients. At least 63 Rezulin users have died of liver failure. The actual number of deaths is estimated to be as many as ten times higher than the reported 63 cases.

Rezulin was banned in England in December 1997, following the death of an American who took the drug. The drug manufacturer, Warner-Lambert, successfully fought a ban in the U.S. for 27 months before the FDA decided to prohibit sales of the drug on March 21, 2000. Before the ban, sales of Rezulin generated Warner-Lambert $1.8 billion in revenues. At its peak, the drug was prescribed 488,000 times in January of 1999.

Sixty three Rezulin users have reportedly died from use of the drug. The deaths were caused by liver failure. The total number of deaths is likely to exceed 63 by many times according to experts.

The March 21, 2000 ban of Rezulin came about after a long debate inside the FDA. Many doctors believed Rezulin was a dangerous drug that needed to be banned. Many inside the FDA believed along with Warner-Lambert's consultants that Rezulin was safe if properly administered and that it should not be pulled from the market.

The recall came after an FDA whistleblower shared his findings and internal FDA email messages with a L.A. Times reporter. This information and interviews with several doctors led to a series of articles in the Los Angeles Times discussing the dangers of Rezulin. The articles also raised questions about the FDA's irregular "fast track" approval of the drug.



Rezulin Basics

Rezulin was used treat type 2 (non-insulin-dependent) diabetics who are using insulin. It lowers the amount of sugar in the blood by helping the body respond better to the insulin.

Why it was prescribed

Doctors prescribed Rezulin in type 2 diabetics who take insulin but whose blood sugar is not well controlled. It was designed to help insulin (either your own or injected) work better, drawing the sugar from your blood into the cells to supply energy.

The drug was approved for diabetics who are insulin users, those taking certain types of oral antihyperglycemic medications, or for diabetics whose diabetes could no longer be controlled by diet and exercise alone.

Rezulin came in 200-milligram (mg) and 400-mg tablets. The maximum dose was 600 mg a day.

The product is also known generically as troglitazone
Brand name: Rezulin (US), Noscal (Japan)
Class: thiazolidinedione
Route of Administration: oral
Dose: 200 mg with a meal; if no improvement within a few weeks, can increase to 400 mg with a meal (and later to 600 mg).
Previously available as: 200 mg, 300 mg, and 400 mg tablets.
Previously recommended by FDA for: Type 2 diabetes, in combination with sulfonylurea pills, or combination with both sulfonylurea pills and metformin, or with insulin injections.
Action: improves the action of the liver, muscles, and fat tissues (functions as an "insulin sensitizer")
Side Effects: Fluid retention, increased fertility, liver disease (see below).
US manufacturer: Parke-Davis division of Warner-Lambert (Developed by Sankyo Pharmaceutical Company in Japan)
Status: Withdrawn by the manufacturers March 21, 2000 in the USA, and in Japan, the Philippines, and Australia.
Suspended in the United Kingdom in December 1997, pending review of safety data and later withdrawn from the UK market.
Other drugs in same class: pioglitazone, rosiglitazone



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