Unrelated drug, but similar in a FDA cautionary stance.
INDIANAPOLIS--(BUSINESS WIRE)--Sept. 17, 2003--Eli Lilly and Company (NYSE:LLY) has received a letter from the U.S. Food and Drug Administration (FDA) requesting updated product labeling for all atypical antipsychotics, to include a warning about additional information on hyperglycemia and diabetes. In addition to Zyprexa(R) (olanzapine), the atypical antipsychotic class includes Clozaril(R) (clozapine, Novartis), Risperdal(R) (risperidone, Janssen), Seroquel(R) (quetiapine, AstraZeneca), Geodon(R) (ziprasidone, Pfizer), and Abilify(R) (aripiprazole, Bristol Myers Squibb).
"Increased attention to the signs and symptoms of diabetes mellitus may lead to earlier detection and appropriate treatment, and thus may reduce the risk for the most serious outcomes," the FDA stated in its letter to Eli Lilly and Company received September 15, 2003.
"Risk for diabetes should be considered among patients with severe mental illness regardless of medication choice," said Mauricio Tohen, MD, Dr. PH. Lilly Research Fellow and Leader of the Zyprexa Product Team.
The Agency recognizes that the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood, but epidemiological studies have suggested some increased risk. The requested labeling states, "Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population."
The labeling further states that patients with diabetes who begin taking atypical antipsychotics should be monitored for a worsening of glucose control, and those with risk factors for diabetes (e.g., obesity, family history of diabetes) should undergo fasting glucose testing at baseline, and periodically throughout treatment. Any patient developing suggestive symptoms during treatment with an atypical antipsychotic should be tested for diabetes.
"Lilly is committed to continuing to provide resources for complete wellness for patients," Dr. Tohen said. "It is clear that this important area requires more research and Lilly is determined to remain in the forefront of this scientific inquiry," he added. |
