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Health

Diabetes drug linked to 33 deaths

graphic December 2, 1998
Web posted at: 5:43 p.m. EDT (1743 GMT)

From Medical Correspondent Holly Firfer

WASHINGTON (CNN)- CNN has confirmed the story first reported in the Los Angeles Times Sunday on a new diabetes drug called Rezulin and its link to 33 deaths.

An official at the FDA said the drug can be highly toxic and can cause liver injuries or even death if not monitored closely. But, the official adds, for the majority of diabetic patients who can not control their blood sugar, the drug's benefits greatly outweigh the risks. The FDA stands by its approval of the drug and its uses.

Rezulin is from a new class of drugs to control blood sugar levels in diabetics and is particularly effective in extremely obese patients whose blood sugar levels remain uncontrolled even after increased insulin doses.

The drug, made by the pharmaceutical division of Warner-Lambert, was approved on the FDA's so called "fast track" approval process in January of 1997.

In most cases, it takes years for a drug to gain approval by the FDA for use in the U.S.; however, drugs deemed to be effective for very serious illnesses can be put on a "fast track" approval process, which can cut the review time to less than half. In this case, Rezulin was approved in just six months.

According to the FDA, because diabetes is a very serious disease, it warranted speeding up the approval process, despite many warnings from other FDA officials involved in the review process about the serious side effects, which can include nausea, fatigue and jaundice, and eventually irreversible liver failure.

The FDA had sent reccomendations to doctors using the treatment to test patients for liver damage every month for the first eight months of use, and every two months after the first year. The FDA still sticks to those reccomendations and still supports the use of the drug because of the success rate of reducing blood sugar levels in patients.

Diabetes is a condition in which the body produces little or no insulin. Insulin is a hormone that allows sugar to be stored or used for energy. In diabetics, the level of sugar in the blood becomes very high. Rezulin is designed to lower blood sugar levels in patients.

Warner-Lambert will continue to market Rezulin and the FDA says they will monitor the drug closely.

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