Lilly Commends Surgeon General's Report on Bone Health
October 14 2004 - 2:15PM
PR Newswire (US)
Lilly Commends Surgeon General's Report on Bone Health Medical
Director likens bones to architecture, emphasizes prevention
INDIANAPOLIS, Oct. 14 /PRNewswire-FirstCall/ -- Today the Surgeon
General of the United States of America released the office's first
opinion on bone health, emphasizing the importance of lifestyle
choices in maintaining strong bones. As a manufacturer of
innovative osteoporosis treatments, Eli Lilly and Company commends
the Surgeon General's foresight and dedication to addressing the
importance of maintaining healthy bones. "Our bones are the
fundamental architecture of our bodies. Like bricks in a building's
foundation, if they crumble or fracture, the entire structure is
weakened and compromised," said K. Shaw Lamberson, MD, Medical
Director of Lilly's Women's Health & Reproductive Medicine
Division. But unlike actual architecture, bones constantly rebuild
themselves, which is why taking care of them is so important --
bones are living tissue, constantly going through a cycle of
regeneration. By doing regular, weight- bearing exercise and
getting enough calcium and vitamin D, you increase the likelihood
that your bones will remain strong for a lifetime. More than 50
percent of all women over the age of 75 are estimated to have
osteoporosis, and due to their advanced age, have a high risk for
fracture. In fact, most American women over the age of 50 will
experience one or more osteoporosis related fractures during their
lifetime. "Awareness is one of the key artillery we have to battle
osteoporosis. This is an exciting day for those who have fought to
raise awareness and find solutions to this often silent disease,"
said Lamberson. "The Surgeon General has given the public this
great resource, and now it's up to the public to take the steps
necessary to protect their body's structural integrity by focusing
on prevention." Lilly's osteoporosis unit provides a continuum of
care for the disease, the only pharmaceutical company to
manufacture medicines that uniquely treat the disease in each of
its stages. Lilly manufactures two osteoporosis medications:
EVISTA(R) (raloxifene HCl), the first SERM (Selective Estrogen
Receptor Modulator) approved for use in preventing and treating
osteoporosis in postmenopausal women, and FORTEO(R) (teriparatide
[rDNA origin] injection) the first and only bone formation agent
approved for the treatment of osteoporosis in postmenopausal women
who are at high risk for fracture, and to increase bone mass in men
with primary or hypogonadal osteoporosis who are at high risk for
fracture. These include men (and postmenopausal women) with a
history of osteoporosis-related fracture, or who have multiple risk
factors for fracture, or who have failed or are intolerant to
previous osteoporosis therapy based on physician assessment.
Important Safety Information about EVISTA EVISTA is not for
everyone. If you are or still can become pregnant, are nursing,
have severe liver problems, or have had blood clots that required a
doctor's treatment, you should not take EVISTA. An infrequent but
serious side effect of EVISTA is blood clots in the veins -- being
immobile for a long time may add to the risk. The most commonly
reported side effects were hot flashes and leg cramps. Side effects
with EVISTA have usually been mild, and most women didn't find them
serious enough to stop taking it. You may be at increased risk for
osteoporosis if you are Caucasian (white) or Asian, have a slender
build, don't exercise, or have a family history of the disease. If
you don't get enough calcium and/or vitamin D in your diet, you
should also take these supplements. For full prescribing
information, please visit http://www.evista.com/ Important Safety
Information about FORTEO In two-year studies in rats, teriparatide
caused an increase in the incidence of osteosarcoma, a malignant
bone tumor, which was dependent on dose and duration of treatment.
Although no case of osteosarcoma has been reported in the patients
who received FORTEO in clinical trials, it is not known if humans
treated with FORTEO are at increased risk for this cancer. FORTEO
should be prescribed only to patients for whom the potential
benefits are considered to outweigh the potential risk. The drug
should not be prescribed for patients at increased baseline risk
for osteosarcoma, including patients with Paget's disease of bone
or unexplained elevations of alkaline phosphatase, children or
growing adults, or those who have had prior external beam or
implant radiation therapy involving the skeleton. Additionally,
patients with bone metastases or a history of skeletal
malignancies, and those with metabolic bone diseases other than
osteoporosis, should not receive FORTEO. Patients with high levels
of calcium in their blood should not receive FORTEO due to the
possibility of increasing their blood levels of calcium. In
clinical trials, the most frequent treatment-related adverse events
reported at the 20-microgram (mcg) dose approved for marketing were
mild, similar to placebo and generally did not require
discontinuation of therapy. Reported adverse events that appeared
to be increased by FORTEO treatment were leg cramps and dizziness
(2.6 and 8 percent, respectively), compared with placebo (1.3
percent and 5.4 percent, respectively). FORTEO is supplied in a
disposable pen device that can be used for up to 28 days to give
once-daily self-administered injections. FORTEO is available in a
20-mcg dose and should be taken for a period of up to 24 months.
Lilly has implemented a risk management program that includes
comprehensive measures regarding the appropriate use of FORTEO in
the target patient population. A Medication Guide explaining the
details of the drug to the patient also accompanies the product.
FORTEO also has a black box warning in its package insert about the
osteosarcoma findings in rats during preclinical testing. For full
prescribing information, please visit http://www.forteo.com/ .
About Osteoporosis More than 50 percent of all women over the age
of 75 are estimated to have osteoporosis, and due to their advanced
age, have a high risk of fracture. In fact, most American women
over the age of 50 will experience one or more osteoporosis-related
fractures during their lifetimes, and women with osteoporosis who
have two or more previous fractures have up to a nine times greater
risk of future fracture compared with women who have not suffered a
previous fracture. About Lilly Lilly, a leading innovation-driven
corporation, is developing a growing portfolio of first-in-class,
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/ . Evista(R) (raloxifene hydrochloride, Lilly)
Forteo(TM) (teriparatide [rDNA origin] injection, Lilly) (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: Keri S. McGrath of Eli Lilly and
Company, +1-317-651-6001, Email: Web site: http://www.lilly.com/
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