Lilly Announces FDA Notification of Class Labeling for Atypical Antipsychotics Regarding Hyperglycemia and DiabetesSep 17, 2003 | BUSINESS WIRE
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.
Zyprexa is indicated in the United States for the short- and long-term treatment of schizophrenia and for acute bipolar mania. Since Zyprexa was introduced in 1996, it has been prescribed to more than 12 million people worldwide.
The most common treatment-emergent adverse event associated with ZYPREXA in placebo-controlled, short-term schizophrenia and bipolar mania trials was somnolence. Other common events were dizziness, weight gain, personality disorder (COSTART term for nonaggressive objectionable behavior), constipation, akathisia, postural hypotension, dry mouth, asthenia, dyspepsia, increased appetite, and tremor.
A small number of patients in premarketing trials experienced asymptomatic elevations of hepatic transaminase; none of these patients developed jaundice. Periodic assessment of transaminases is recommended in patients with significant hepatic disease.
Prescribing should be consistent with the need to minimize the risk of neuroleptic malignant syndrome, tardive dyskinesia, seizures, and orthostatic hypotension. Full prescribing information is available at www.zyprexa.com.
This press release contains statements about potential label changes for Zyprexa and other atypical anti-psychotic drugs, and forward-looking statements about future research involving Zyprexa.
These statements reflect management's current beliefs, however, as with any commercial pharmaceutical product, there are risks and uncertainties in the process of commercialization and regulatory review.
There are no guarantees that the potential label changes will occur or that the product will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.