Dallas Fort Worth Injury Lawyer Blog
Shortly after new antipsychotic drugs came on the market in the late 1990s, the Food and Drug Administration started to worry that they might trigger diabetes in some patients.
So in 2000, the FDA asked AstraZeneca P.L.C. and other pharmaceutical companies to share data on cases of new-onset diabetes and related illnesses in patients taking the drugs. AstraZeneca, told the FDA that patients and doctors had reported 12 new cases of diabetes and five cases of related illnesses among the 623,000 who had taken its antipsychotic drug Seroquel.
But internally, the company had reported the number as 27 cases of diabetes and two of hyperglycemia, according to court documents recently released.
The documents surfaced in lawsuits filed in Orlando, Fla., by patients who say taking Seroquel caused their diabetes. Last month, the FDA required AstraZeneca to make information about Seroquel and weight gain, a risk factor in diabetes, more prominent on the drug’s label.
In a 2008 deposition, AstraZeneca’s medical director, explained the difference between the 12 and 27 cases by saying the company had given the FDA only what it requested.
In its 2000 response to the agency, AstraZeneca said it was “unlikely” that taking Seroquel led to diabetes.
AstraZeneca faces personal-injury claims from about 15,000 people who took Seroquel and say it caused diabetes. A judge dismissed the first two cases, saying the patients had failed to show Seroquel caused their diabetes; the other cases are pending.
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