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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SOURCE Eli Lilly and Company
