Lilly Announces FDA Notification of
Class Labeling for Atypical Antipsychotics Regarding Hyperglycemia
and Diabetes
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.
Zyprexa Background
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.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories
and from collaborations with eminent scientific organizations.
Headquartered in Indianapolis, Ind., Lilly provides answers -
through medicines and information - for some of the world's most
urgent medical needs. Additional information about Lilly is
available at
www.lilly.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. |
