AstraZeneca hid diabetic link of Seroquel information from US people

Seroquel is an antipsychotic drug manufactured and marketed by London based drug maker AstraZeneca Plc. It has diabetes related side effects. In clinical trials of the drug, patients have been diagnosed with diabetes mellitus, hyperglycemia and weight gain.

The company issued a letter to Japanese physicians in November 2002 informing them about the diabetes link of the drug. It mentioned that 12 Seroquel users have been diagnosed with high blood-sugar levels over a period of 21 months.

Among the 12 one was dead, the others were diseased by  hyperglycemia, diabetic ketoacidosis and diabetic coma. Hyperglycemia is the medical term for high blood-sugar levels. Diabetic ketoacidosis refers to a condition where the human body does not produce enough insulin.

They also advised Japanese doctors not to prescribe the drug to diabetic patients and to ensure that users monitor their blood glucose levels.

But the same AstraZeneca pushed salespeople to tell U.S. doctors that the medicine did not cause diabetes. AstraZeneca sales managers were instructing company representatives to tell U.S. physicians that “the available data has not established a causal link between diabetes and Seroquel” . Also Seroquel’s label didn’t advise US doctors to monitor blood glucose levels until January 2004.

According to an AstraZeneca spokesperson, the company sent letter to Japanese doctors at the request of that nation’s regulators. However Sidney Wolfe, director of Washington-based Public Citizen’s health-research group and a member of the FDA’s drug safety committee believes that if there is enough evidence to warn people in Japan, there’s enough evidence to warn people in US. This is sheer irresponsibility in the part of the company.

More than 15,000 patients have sued AstraZeneca, claiming the company withheld information about links between diabetes and Seroquel use from doctors and patients. Many of the lawsuits also claim AstraZeneca promoted Seroquel, approved by the U.S. Food and Drug Administration for schizophrenia and bipolar disorder, for unapproved uses.

Source:bloomberg.com

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