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Since Rezulin was approved on the fast track a complete clinical trial to determine possible heart damage caused by Rezulin was not completed. Instead, the Echo Study was put together to determine whether the use of Rezulin for 48 weeks would result in a change in the left ventricle. The endocrinologist who served as Warner-Lambert’s principal investigator for the Echo study in Buffalo, Dr. Paresh Dandona, said “The Echo Study was not properly conducted, according to the standard protocol. I was not made aware of the fact that the patients from this site, in particular, for whatever reason, whether it was due to technique or whatever, that they had increased left ventricular mass,” (LA Times, 3-26-00).
After the FDA approval of Rezulin on January 29, 1997, officials had 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. Rezulin patients did die of heart failure, but doctors claimed many of these patients had preexisting heart problems. Guston Turner, a pharmacist from the FDA’s scientific investigations division had found inconsistencies in research measuring Rezulin’s effect on the heart. Turner felt that the FDA “should have delayed approval of Rezulin until all the questions were addressed.”
An $11.55 million Rezulin lawsuit award has been upheld to a woman whose husband died after suffering liver failure. The man was hospitalized of liver failure in 1999, a month within being prescribed Rezulin, and died one week later. Rezulin, a diabete...
A $60 million settlement in an Illinois class action lawsuit has been reached with Rezulin diabetes drug maker Pfizer Inc. The lawsuit, filed in 2002, alleged Rezulin caused liver problems in five percent of the people who used it, which contradicts ad...
Pfizer, the world''s largest drugmaker, bought Warner-Lambert three months after the company issued a Rezulin recall in 2000. The Rezulin recall has resulted in lawsuits after allegations of liver damage leading to death, liver transplant, or damage. <...
Drug Recall Includes Rezulin - Rezulin recall information on side effects including liver failure and liver damage. Access to Lawyers specializing in Rezulin available on this site.