Lilly Announces Important Liver Safety Update to Strattera® Label
December 17, 2004

INDIANAPOLIS, Dec 17, 2004 /PRNewswire-FirstCall via COMTEX/ -- Eli
Lilly and Company announced today that it has added a bolded warning
to the product label for Strattera, an attention
deficit/hyperactivity disorder (ADHD) medication. The bolded warning
indicates that the medication should be discontinued in patients
with jaundice (yellowing of the skin or whites of the eyes) or
laboratory evidence of liver injury. This label change discusses two
reported cases of severe liver injury out of the more than 2 million
patients who have taken the medication since approval. Both patients
have recovered with normal liver function after discontinuing the
medication.

"Patient safety is our top priority at Lilly. When we learned of the
first case, we reported it to the FDA and began a thorough
investigation, including consultation with outside experts and a
review of all the available data," said Douglas Kelsey, M.D., a
pediatrician and a clinical research physician at Eli Lilly and
Company. "We worked closely with the FDA to determine the best
course of action, and as a result, are taking a number of measures
to notify healthcare professionals and ultimately patients. In
addition, our thorough review of the clinical trial and real-world
data indicate that the benefit- risk profile for Strattera is
positive, and the medication continues to be an important treatment
option for patients with ADHD."

The company is in the process of notifying physicians, other health
care providers and consumer advocacy and professionally focused
associations about this label change so they can provide important
information to patients. Lilly's outreach efforts include a "Dear
Healthcare Professional" letter, sales force communications to
prescribers and information on Strattera.com.

Liver Reactions in Medications

All prescription products have risks that physicians and patients
should consider. While liver complications are rare, other
medications across the broad spectrum of prescription and over-the-
counter medications available today demonstrate the same type of
liver effects and continue to be used safely. However, in a small
percentage of patients, severe drug-related liver injury may
progress to acute liver failure resulting in death or the need for a
liver transplant.

Experts say that the signs and symptoms of liver effects can alert a
patient to a potential problem. Patients should contact their doctor
immediately if they develop:

-- Pruritus (Itchy skin)
-- Jaundice
-- Dark urine
-- Upper right-sided abdominal tenderness
-- Or unexplained "flu-like" symptoms

Strattera-Specific Information

The 6,000 patients taking Strattera in clinical trials experienced
no evidence of liver injury. Real-world reports indicate that
Strattera can cause severe liver injury in rare cases. Because of
probable underreporting, it is impossible to provide an accurate
estimate of the true incidence of these events. However, even when
accounting for underreporting, real-world incidence of liver injury
among patients taking the medication is less than the rate expected
for the overall population.

If parents or patients have additional questions, please call the
Lilly Answers Center at 1-800-LillyRx or log onto www.strattera.com.
The updated Strattera label is on the Web site.

About ADHD

ADHD affects 3-7 percent of school-age children and manifests itself
in levels of attention, concentration, activity, distractibility and
impulsivity that are inappropriate to the child's age.(1) In
addition, 60 percent of children with the disorder carry their
symptoms into adulthood.(2) Experts estimate 4 percent of adults in
the United States, more than 8 million people, have ADHD. (3,4)

About Strattera

Strattera, a selective norepinephrine reuptake inhibitor, is the
first FDA approved non-stimulant to treat ADHD and provide full-
symptom relief. It is not known precisely how Strattera reduces ADHD
symptoms, but scientists believe it works by blocking or slowing
reabsorption of norepinephrine, a chemical in the brain considered
important in regulating attention, impulsivity and activity levels.
This keeps more norepinephrine at work in the spaces between neurons
in the brain. Improved efficiency in the norepinephrine system is
associated with improvement in symptoms of ADHD (Pliska, 1996).

Strattera should not be taken at the same time as, or within two
weeks of taking, a monoamine oxidase inhibitor (MAOI) or by patients
with narrow angle glaucoma. Patients with a history of high or low
blood pressure, increased heart rate, or any heart or blood vessel
disease should tell their doctor before taking Strattera. Strattera
has not been tested in children less than 6 years of age or in
geriatric patients. Some children may lose weight when starting
treatment with Strattera. As with all ADHD medications, growth
should be monitored during treatment. Strattera can cause liver
damage in rare cases. Patients should tell their doctor right away
if they have itching, dark urine, yellow skin/eyes, upper right-
sided abdominal tenderness, or unexplained "flu-like" symptoms.

Most people in clinical studies who experienced side effects were
not bothered enough to stop using Strattera. The most common side
effects in children and adolescents in medical studies were upset
stomach, decreased appetite, nausea and vomiting, dizziness,
tiredness and mood swings. In adults, the most common side effects
were constipation, dry mouth, nausea, decreased appetite, dizziness,
problems sleeping, sexual side effects, problems urinating and
menstrual cramps.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of first-in-class and 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 .

(P-LLY)

For full prescribing information visit www.strattera.com.

This press release contains forward-looking statements about the
potential of Strattera for the treatment of ADHD and reflects
Lilly's current beliefs. However, as with any pharmaceutical
product, there are substantial risks and uncertainties in the
process of commercialization. There is also no guarantee 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.

(1) American Psychiatric Association: Diagnostic and
Statistical Manual
of Mental Disorders, fourth edition, text revision,
Washington, DC,
American Psychiatric Association, 2000.
(2) Schweitzer JB, et al. Attention-deficit/hyperactivity
disorder. Med
Clin of North Am. 2001; 85(3): 757-777
(3) Murphy K, Barkley, RA. J Atten disord. 1996; 1:147-161.
(4) United States Census Summary File; 2000.

(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )

SOURCE Eli Lilly and Company

Jennifer Bunselmeyer of Eli Lilly and Company, cell, +1-317-
997-1755, pager, +1-888-462-2576 , or Bunselmeyer_Jennifer@...
/Photo: NewsCom: http://www.newscom.com/cgi-
bin/prnh/20031219/LLYLOGO
PRN Photo Desk, photodesk@...
(LLY)

Copyright © 2004 PR Newswire. All rights reserved.

News Provided by COMTEX


Copyright © 2004 Eli Lilly and Company | All rights reserved |
Privacy Statement | Site Map