Submit your Rezulin claim details for a free, no obligation case review
Get Started:
Rezulin heart damage can be caused by the drug''s tendency to exacerbate a pre-existing heart condition. In 1996, an FDA diabetes specialist Dr. Robert Misbin was most concerned with “its potential for cardiac toxicity”. Undisclosed documents showing that concerns were raised about liver conditions also show that concerns were raised on Rezulin’s effect on the heart. An L.A. Times article from March 26, 2000 included Guston Turner, a pharmacist from the FDA’s scientific investigations division, who 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.”
In the mid 1990s, FDA pharmacologists were surprised by the findings of what they saw in animals when given doses of Rezulin. The animals ended up with discolored and overweight hearts that were Rezulin related. Rats, dogs, and monkeys had developed heart problems from Rezulin, enough of an issue to cause a former FDA medical officer, Dr. John L. Gueriguian, to recommend Rezulin’s rejection in the 1990s after studying the diabetes drug. Gueriguian found that “in rats, in dogs, in monkeys- I’ve never seen a class of drug that had such a consistent pattern of cardiopulmonary toxicity,” (LA Times, 3-26-00).
While these findings in animals may not indicate Rezulin would have the same effect in humans, the possibility of Rezulin worsening a delicate preexisting vulnerability to heart failure could occur if Rezulin did cause abnormal fluid retention and weight gain. 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. One hundred fourteen Rezulin patients completed the study and no one was found to suffer a heart failure. But the FDA looked at the data and found that 26% of the Rezulin patients involved in the study dropped out, leading them to believe there were irregularities in the data.
In January 1997, the FDA had Turner, a veteran agency pharmacist, complete the review of Rezulin in the remaining three weeks in Buffalo and Omaha. Based off of Turner’s findings, the director of the FDA’s endocrine-drug division, Dr. Solomon Sobel, wrote in an email on January 13, 1997 that it was “disturbing” that variations existed in how different Warner-Lambert consultants had interpreted the same echocardiogram data recorded at Omaha. In Buffalo, Turner found that the echocardiograms had indicated an increase in left-ventricular-wall thickness. Both cases had ended with a senior FDA official making concessions in Warner-Lambert’s favor.
Turner later said of the Echo Study on Rezulin, “the real problem there was whether there was any heart enlargement or not. They ignored it,” (LA Times, 3-26-00). Even 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.
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. <...
Copyright © 2001 - 2009 Online Lawyer Source | Legal Marketing Site Designed by eJustice