Eli Lilly (NEO:LLY)
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Lilly Announces Important Liver Safety Update to Strattera(R)
Label
INDIANAPOLIS, Dec. 17 /PRNewswire-FirstCall/ -- 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 http://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 http://www.lilly.com/ .
(P-LLY)
For full prescribing information visit http://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.
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DATASOURCE: Eli Lilly and Company
CONTACT: Jennifer Bunselmeyer of Eli Lilly and Company, cell, +1-317-
997-1755, pager, +1-888-462-2576 , or