Warner-Lambert Officials Failed To Inform FDA About Rezulin’s Potential Side Effects
Executives at Warner-Lambert Co., which marketed the diabetes treatment Rezulin, did not tell FDA officials about "early indications of the drug's danger to the liver" and delayed telling doctors about its "lethal toxicity," according to internal company documents obtained by the Los Angeles Times. The Times reports that an "unorthodox method" used by Randall Whitcomb, at the time Warner-Lambert's vice president for diabetes research, to count liver injuries in patients taking Rezulin in clinical trials "trimmed the number of cases" of liver damage that the company reported to the FDA and gave a "markedly more benign view" of Rezulin's risks. It is illegal in the United States to "deliberately conceal an important fact" about a prescription drug's safety, the Times reports. The clinical trial results led to FDA "fast-track" approval of the drug in 1997. Subsequently, the FDA linked 94 cases of liver failure to Rezulin -- 66 of them fatal. A Times review of FDA records found that doctors cited Rezulin as a suspected factor in 556 fatalities, "including but not limited to" the deaths from liver failure, the Times reports. The drug was removed from the U.S. market in March 2000; Pfizer Inc. bought Warner-Lambert shortly thereafter. About 5,100 Rezulin users or their survivors have filed more than 2,000 lawsuits against the company (Willman, Los Angeles Times, 6/30). Last December, Pfizer settled one of the lawsuits for an undisclosed amount just hours after a Texas jury ordered the pharmaceutical company to pay the plaintiff $43 million in compensatory damages (American Health Line, 1/2).
The Times review also found that:
- Warner-Lambert representatives in 1998 discussed how to persuade doctors to "take the risk" of prescribing Rezulin to their Latino patients because they were "easy to intimidate." Latinos are twice as likely as non-Latino whites to have type 2 diabetes (Willman, Los Angeles Times, 6/30).
- After a Rezulin user died of liver failure in 1998, Warner-Lambert representatives "argued against promptly alerting" the doctors of other patients taking the medication.
- Warner-Lambert reimbursed doctors if they were sued for prescribing Rezulin. The American Medical Association has called such reimbursements "unacceptable gifts" and advises doctors not to accept them.
Responding to the information contained in the documents obtained by the Times, Pfizer spokesperson Robert Fauteux said that the product label for Rezulin "appropriately communicated the risks associated with the medication, including the risk of liver injury," and added that "in developing Rezulin, Warner-Lambert made a valuable contribution to the effort to control diabetes" (Los Angeles Times, 6/30).
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