In March of 1997, Warner-Lambert Company introduced Rezulin as the newest drug on the market for the treatment of type 2 adult onset diabetes. U.S. Food and Drug Administration approval followed an extraordinary accelerated six-month review, making Rezulin the fastest-approved diabetes pill in the nation. Rezulin was hailed as the first drug in its class to treat abnormal blood sugar levels by helping the body respond to insulin. Warner Lambert heavily marketed Rezulin's effectiveness along with its reputed safety. Warner Lambert referred to Rezulin as a potential "billion dollar blockbuster." Indeed, the drug's market is vast-15 million type 2 diabetics in the United States alone. As part of the promotional campaign, the manufacturer catered to diabetes specialists with vacation packages, including such things as complimentary flights and hotel accommodations for the 1996 Olympic Games in Atlanta. Wall Street analysts were targeted with slide shows that emphasized Rezulin's profitable market. Widespread efforts were made to ensure Rezulin's immediate success.

Unfortunately, Rezulin's long term risks were minimized and not shared with the general public. As early as October of 1996, a medical reviewer from the FDA had recommended that this drug be rejected because of its toxicity to the liver. This reviewer was subsequently banned from further evaluation of the drug and his review was removed from the FDA's files. It is believed that Warner Lambert was well aware of Rezulin's potential to cause liver failure, yet still moved forward with its marketing strategies.

It was not until October of 1997 that Warner Lambert publicly admitted that the use of Rezulin was associated with liver problems and recommended routine liver function tests for its users. Several years later, at the request of Dr. Sidney Wolfe of Public Citizen's Health Research Group, the FDA initiated an investigation of Warner Lambert's clandestine research regarding the connection between Rezulin and liver injury. On March 21, 2000, after it's $2.1 billion in sales and 63 confirmed liver failure deaths, Rezulin was removed from the market at the request of the FDA. The tenure of this "diabetes breakthrough" had come to an end, but not before the drug caused or contributed to severe health consequences for thousands of diabetics.

Since Rezulin's demise, further health studies have been conducted. In addition to its liver toxicity, Rezulin has also been linked to possible heart damage and colon cancer. An estimated 2 million Americans used Rezulin in the treatment of their type-2 diabetes. It is still unknown just how many of these patients have suffered health problems as a result of this deadly drug.

If you or a loved one took Rezulin, we can help. Call Mark A. Hunt & Associates for an appointment.