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Launched in the late 1990s, Rezulin had been considered a major advancement for diabetes drugs, but three years later, the FDA requested that manufacturer Parke-Davis/Warner-Lambert remove it from the market for rare but extremely severe liver problems and cardiovascular issues.
Since that point, Pfizer, which took over Parke-Davis/Warner-Lambert, has been embroiled with thousands of lawsuits at state and federal levels. Plaintiffs allege the manufacturer concealed crucial data to get the FDA to approve Rezulin.
Generically known as Troglitazone, Rezulin is part of a drug class known as thiazolidinediones. When it was launched in 1997, doctors prescribed it to Type 2 diabetes patients already using insulin but whose blood sugar was still not well controlled by diet and exercise. Rezulin supposedly drew sugar from the blood to cells in order to supply energy.
However, while the drug had been prescribed to 488,000 patients in January 1999 alone, its popularity was brief. The U.K. banned it in 1997, and by March 2000, the FDA requested Parke-Davis/Warner-Lambert remove it from shelves, after data comparing it to Avandia and Actos showed Rezulin to be more toxic to the liver.
At the time, the FDA had 47 reports of liver problems, including autoimmune hepatitis. As well, there were 63 reports of death, although that number was later found to be 400. Hundreds more experienced liver failure.
Claims totaling to 4,200 in the early 2000s alleged Parke-Davis/Warner-Lambert concealed and withheld information from the FDA after liver toxicity was discovered during clinical trials. By 2004, Pfizer settled a class action lawsuit for $60 million concerning the drug’s marketing, with the plaintiff alleging the manufacturer misrepresented safety risks in its advertisements.
By 2008, the U.S. Supreme Court allowed Michigan patients to sue Pfizer, with 27 plaintiffs claiming Rezulin directly caused liver injuries and alleging Parke-Davis/Warner-Lambert engaged in fraud by misleading the FDA. Since that point, Pfizer settled 35,000 claims for $450 million.