Healthy Skepticism Library item: 287

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Publication type: news

Anand G.
Drug Debate: New Antipsychotics Pose a Quandary For FDA, Doctors--- Eli Lilly's Big Seller, Zyprexa, Can Help Schizophrenics; Is It Linked to Diabetes? --- Warnings Abroad, Not in U.S.
Wall Street Journal 2003 Apr 11

Full text:

The young woman was hospitalized for a week and released, still taking Zyprexa, in addition to insulin, which controls blood-sugar levels. Dr. Thomas Johnson says that neither he nor doctors at the hospital initially considered any potential connection between Zyprexa and the patient’s blood-sugar problem because the drug’s label lacks any alert on the topic.

After he found reports on the Internet about the drug and diabetes, he took the patient off Zyprexa. Her blood sugar returned to normal, he says.

A team of researchers, led by Elizabeth Koller, a former FDA official, and Dr. P. Murali Doraiswamy of Duke, catalogued the number of diabetes-related complications reported to the FDA in patients taking Zyprexa and Risperdal, the drug made by Johnson & Johnson unit Janssen Pharmaceutica. The researchers reported the possible Zyprexa side-effect cases last July in the journal Pharmacotherapy: Over an eight-year period, 288 diabetes cases, of which 75 resulted in severe illness and 23 in death.

Of the millions who had taken Risperdal over an overlapping nine-year period, Dr. Koller’s group found 132 diabetes cases, 31 of which involved life-threatening complications and five that ended in death. The findings were based on voluntary reports to the FDA, which scientists estimate reflect between 1% and 10% of actual cases.

Robert W. Baker, a senior clinical research scientist at Lilly, says the company has spent millions of dollars on research evaluating the diabetes question. Roughly a quarter of Zyprexa patients gain more than 25 pounds while on the medication, Lilly researchers say, and obesity is linked with diabetes. But Dr. Baker says the evidence suggests Zyprexa itself doesn’t cause diabetes-related problems. He says the research suggests that the Zyprexa patients who developed diabetes probably had elevated blood-sugar levels before taking the medication.