Lilly Announces Important Liver Safety Update to Strattera(R) Label
December 17 2004 - 6:30AM
PR Newswire (US)
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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: Jennifer Bunselmeyer of Eli Lilly
and Company, cell, +1-317- 997-1755, pager, +1-888-462-2576 , or
Copyright