Rezulin Recall

The FDA approved Rezulin in January 1997. Warner-Lambert made $2.1 billion in sales before the Rezulin recall was issued in March 2000. Suspected of causing 391 deaths, including hundreds of liver damage cases, Rezulin manufacturer has found themselves in the middle of countless Rezulin lawsuits and investigations.

An FDA study found:

-An estimated 430 or more Rezulin patients have suffered liver failure.

-Rezulin patients have an increased risk of 1,200 times of having a liver failure due to the diabetes drug use.

-One out of every 1,800 Rezulin patients could suffer a liver failure, and at the time of the Rezulin recall there had been an estimated 2 million Rezulin patients.

-Despite the FDA’s instructions and numerous Rezulin label updates for regular liver monitoring, getting liver tests does not guarantee a patient’s safety because Rezulin can attack the liver without warning.

Rezulin was seen as a miracle pill to treat the 15 million Americans that suffer Type-2 diabetes. First marketed as a once a day pill, Rezulin allowed some Type-2 diabetes sufferers to halt insulin injections. On March 21, 2000, per the FDA's request, Warner-Lambert finally issued the Rezulin recall after its controversial run on the U.S. market. The Rezulin manufacturer soon found themselves in the middle of civil lawsuits and criminal and congressional investigations. Currently, Warner-Lambert is still trying to settle the numerous lawsuits brought against them for the large number of liver damage Rezulin caused, as well as heart problems after an estimated 2 million people took Rezulin. A liver specialist and former Warner-Lambert consultant said of Rezulin, "I think as I look back at it retrospectively, there was a problem from the very get-go, in terms of propensity to cause liver problems." Warner-Lambert knew of at least 12 people that had suffered from Rezulin liver damage as early as 1993, but they continued to downplay the potentially life threatening conditions by assuring the diabetes drug was low risk.

Breaking News - SEPTEMBER 2003
Rezulin Lawsuits May Be Getting Harder to Fight Off
New findings published in the Mayo clinic Proceedings show that diabetes drugs may cause heart failure and cause fluid buildup in some patients. The first drug in the newest class of diabetes drugs was Rezulin. In March 2000 regulators found the drug to pose such a great risk of adverse effects that a Rezulin recall was issued. Full Article...

Read More Rezulin Lawsuit News......

Public Citizen director, Dr. Sidney Wolfe, finds Rezulin to be an example of the dangerous practice the FDA uses of, "approving drugs too readily and waiting too long to remove them. It makes some people lose faith in the FDA. It also winds up killing a lot of people that wouldn't have been killed had the drugs not been put on the market in the first place."

If you, or someone you love, has suffered the side effects of Rezulin, contact us to speak with a Rezulin Lawyer!

A Rezulin Recall Newsletter has been created to provide extensive information regarding the entire Rezulin recall and the deadly and serious side effects associated to the diabetes drug. In addition, information on Type-2 diabetes and alternate ways to treat the disease is included. Contact information can also be found on this site to allow Rezulin patients to speak directly to an expert Rezulin lawyer.

Death Count:
Under 50: 12
50-59: 24
60-69: 48
70-79: 33
80 and older: 17
Note: Some victims' ages were not provided
By Year:
1st six weeks: 20 deaths
Note: Rezulin on the market for nine months in 1997
Source: Times analysis of FDA records

Rezulin Recall

Rezulin, described by Public Citizen’s Dr. Sidney Wolfe as “one of the most dangerous drugs” on the market, was finally removed from the U.S. market on March 21, 2000. The diabetes drug, first removed by the British government back in December of 1997, was not removed in the U.S. because FDA officials claimed they were waiting to be sure two newer diabetes drugs were safer. Wolfe thinks, “It is just another example of how low the standards have gotten at FDA.” Rezulin was approved on the FDA’s “fast track” which allows a “breakthrough” drug to go through the approval process in just six months. The diabetes drug was well received because it was the only drug that restored the body’s sensitivity to insulin. Despite reports of liver failure Rezulin patients experienced directly following the drug’s approval, the FDA allowed Rezulin to stay on the market and instead simply ordered Warner-Lambert to strengthen the liver toxicity warnings on Rezulin’s label. After 63 people died as a result of liver failure the director of the FDA’s Center for Drug Evaluation and Research, Dr. Janet Woodcock finally stated, “continued use of Rezulin now poses an unacceptable risk to patients.” An estimated 2 million people used Rezulin.

Rezulin Label

A health policy man at George Washington University in Washington D.C., Thomas Moore, wonders, “Should we have relatively dangerous drugs and simply warn people that they might kill or seriously injure them?” click here to read more about Rezulin label >

About Diabetes

Rezulin was created to treat type-two diabetes, which accounts for over 80% of diabetes cases. click here to read more about diabetes >

Rezulin Controversy

Warner-Lambert, now owned by Pfizer Inc, is now trying to defend against the hundreds of Rezulin lawsuits that have emerged due to the serious liver failure and heart damage effects.
click here to read more >

Rezulin Resources

Resource links for further education on the events and medical implications surrounding the recalled drug Rezulin.
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Rezulin Recall News

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A 1998 Public Citizen survey found the FDA could require manufacturers to conduct phase IV studies as a condition of approval. According to the reports, at least one phase IV study was required for 195 of 306 new drugs approved by the FDA during the 1990s, but just 11 of the 195 Phase IV studies had been completed. This pertains to the safety of Rezulin because a complete clinical trial was not completed prior to the FDA approval of the diabetes drug due to the "fast track" method used on the drug. After Rezulin was approved, official negotiated a nonbonding pledge from Warner-Lambert to start a new study to assess Rezulin's effect on patients who had preexisting heart disease evidence. Few patients were enrolled, and this study was never completed.

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