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FDA Approves Actonel With Calcium For Osteoporosis
in Older Women
Aug. 15, 2005 Late Friday, the Food and Drug
Administration approved a new treatment that is targeted at preventing
and treating osteoporosis in older women. Actonel with Calcium is a
product that provides the fracture protection of Actonel tablets
conveniently packaged with calcium tablets. It is the first prescription
osteoporosis therapy to include calcium, according to a news release
from The Alliance for Better Bone Health, marketer of the prescription
therapy.
"Osteoporosis is a serious, widespread and growing
public health threat," said Judith Cranford, Director, National
Osteoporosis Foundation. "The NOF welcomes any new FDA approved
treatment options, such as Actonel with Calcium, that will help patients
address this all too prevalent disease."
"Actonel with Calcium (risedronate sodium tablets
with calcium carbonate tablets, USP) is a prescription therapy indicated
for the prevention and treatment of postmenopausal osteoporosis," the
company says.
Actonel with Calcium includes four weeks of
therapy. Each week contains seven tablets (one 35 mg once-a-week Actonel
tablet and six tablets that each provide 500 mg calcium). This new
treatment option comes in light of the recent Surgeon General's Report
on Bone Health and Osteoporosis which emphasizes the need for
osteoporosis regimens to be simplified and organized.
"Calcium is a critical component to the
effectiveness of osteoporosis therapy," said Steven Goldstein, MD,
Professor of Obstetrics and Gynecology, at the New York University
School of Medicine. "Actonel with Calcium is an important new tool that
helps simplify the osteoporosis regimen by conveniently delivering two
important elements -- the bisphosphonate and the calcium -- in one
unique package."
Calcium is a basic building block of bone and is
essential for maintaining bone health. Despite this, two new surveys
suggest that many women may not take enough calcium or may take it
incorrectly with a bisphosphonate therapy like Actonel.
According to a study conducted by Information
Resources, Inc. (IRI), 73 percent of women who filled a bisphosphonate
prescription purchased less than the equivalent of one calcium tablet
per day. A second survey conducted by Harris Interactive(R) revealed
that one in four U.S. women aged 50 and over (26 percent) take calcium
within 30 minutes of their bisphosphonate, which decreases the
effectiveness of the bisphosphonate. Both surveys were conducted on
behalf of The Alliance for Better Bone Health.
"Many women need to understand the importance of
how to follow a proper daily calcium regimen to realize the full
effectiveness of an osteoporosis regimen that includes a
bisphosphonate," said Goldstein. "The Actonel with Calcium packaging
system offers women a new way to take their Actonel and their calcium
correctly and consistently."
The Importance of Calcium
When the body does not get enough calcium, it
breaks down bone to help meet its calcium needs. According to the
Surgeon General's Report on Bone Health and Osteoporosis, the average
adult intake of calcium is approximately 700 mg daily, which is below
the U.S. recommended daily allowance (RDA) of 1200 mg for women over 50.
Many women who are taking a bisphosphonate may be able to make up this
difference by taking a 500 mg calcium tablet, which is the amount of
calcium found in Actonel with Calcium (risedronate sodium tablets with
calcium carbonate tablets, USP).
Suggestions for Taking Calcium
* Women aged 50 years and older should get a
total of at least 1200 mg of
calcium through dietary intake and, if necessary, a calcium
supplement.
* Calcium, whether from diet or supplements, is
absorbed best by the body
when it is taken in doses of 500 mg or less of elemental calcium at
one
time.
* Calcium should not be taken at the same time
as a bisphosphonate;
bisphosphonate effectiveness decreases if calcium is taken within
30
minutes.
* Women should talk with their doctors about the
bone health regimen
that's right for them.
About Osteoporosis
Osteoporosis is a silent disease that affects
millions of postmenopausal women, making their bones weak and more
likely to fracture over time. In fact, in the U.S. today, 8 million
women are estimated to already have osteoporosis, and almost 27 million
more are estimated to have low bone mass, placing them at increased risk
for fracture. Each year the incidence of osteoporosis-related fractures
is greater than the incidence of heart attacks, strokes, and breast
cancer combined. The good news is that there are prescription
medications available that effectively reduce both vertebral and
nonvertebral fracture risk.
About Actonel with Calcium
Actonel with Calcium is marketed by The Alliance
for Better Bone Health, a collaboration between Procter & Gamble
Pharmaceuticals and Aventis Pharmaceuticals, now a member of the
sanofi-aventis Group. Actonel with Calcium is a prescription therapy to
prevent and treat postmenopausal osteoporosis and works by slowing or
stopping the cells that cause bone loss.
Selected Safety Information for Actonel with
Calcium
Actonel with Calcium is indicated for the treatment
and prevention of osteoporosis in postmenopausal women. Actonel with
Calcium is contraindicated in patients with known hypersensitivity to
any component of this product, or inability to stand or sit upright for
at least 30 minutes. Actonel(R) (risedronate sodium tablets) and Calcium
are contraindicated, respectively, in patients with hypocalcemia and
hypercalcemia. These and other disturbances of bone and mineral
metabolism should be effectively treated before starting Actonel with
Calcium therapy. Actonel with Calcium is not recommended for use in
patients with severe renal impairment (creatinine clearance < 30
mL/min). In patients with conditions causing or predisposing to
hypercalcemia and in patients with a history of kidney stones, the
administration of calcium should be assessed prior to prescribing and
then monitored appropriately.
Bisphosphonates may cause upper gastrointestinal
disorders such as dysphagia, esophagitis and esophageal or gastric
ulcer. Patients should pay particular attention to the dosing
instructions, as failure to take the drug according to instructions may
compromise clinical benefits and may increase the risk of adverse
events. Calcium may cause gastrointestinal adverse effects such as
constipation, flatulence, nausea, abdominal pain, and bloating.
Among patients treated with bisphosphonates, there
have been infrequent reports of severe and occasionally incapacitating
bone, joint and/or muscle pain. Rare occurrences of osteonecrosis,
primarily of the jaw (ONJ), have been reported in patients receiving
bisphosphonates. Most ONJ cases have occurred in cancer patients
undergoing dental procedures. In the majority of cases reported,
patients had received intravenous bisphosphonate therapy.
In clinical trials, Actonel was generally well
tolerated. The overall incidence of adverse events with Actonel 5 mg
daily was comparable to placebo. The most commonly reported adverse
events regardless of causality were infection (primarily upper
respiratory, placebo 29.7% vs Actonel 5 mg 29.9%), back pain (23.6% vs
26.1%), and arthralgia (21.1% vs 23.7%).
In a 1-year clinical trial comparing Actonel 35 mg
Once-a-Week and Actonel 5 mg daily, the overall incidence of adverse
events with the two dosing regimens was similar. The most commonly
reported adverse events regardless of causality were infection (Actonel
35 mg 20.6% vs Actonel 5 mg 19.0%), arthralgia (14.2% vs 11.5%) and
constipation (12.2% vs 12.5%). For more information about Actonel with
Calcium, please see full prescribing information at
www.actonel.com.
The Source:
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed by
Procter & Gamble Pharmaceuticals and Aventis Pharmaceuticals, now a
member of the sanofi- aventis Group, in May 1997 to promote bone health
and disease awareness through numerous activities to support physicians
and patients around the globe.
About P&G (NYSE:PG)
Two billion times a day, P&G brands touch the lives
of people around the world. The company has one of the strongest
portfolios of trusted, quality, leadership brands, including Pampers(R),
Tide(R), Ariel(R), Always(R), Whisper(R), Pantene(R), Bounty(R),
Pringles(R), Folgers(R), Charmin(R), Downy(R), Lenor(R), Iams(R),
Crest(R), Actonel(R), Olay(R) and Clairol Nice 'n Easy(R), Head &
Shoulders(R), and Wella. The P&G community consists of almost 110,000
employees working in over 80 countries worldwide. Please visit http://www.pg.com
for the latest news and in-depth information about P&G and its brands.
About sanofi-aventis
The sanofi-aventis Group is the world's third
largest pharmaceutical company, ranking number one in Europe. Backed by
a world-class R&D organization, sanofi-aventis is developing leading
positions in seven major therapeutic areas: cardiovascular, thrombosis,
oncology, metabolic diseases, central nervous system, internal medicine,
and vaccines. The sanofi-aventis Group is listed in Paris (EURONEXT:
SAN) and in New York (NYSE:SNY)
The sanofi-aventis Group conducts its business in
the United States through its subsidiaries Sanofi-Synthelabo Inc.,
Aventis Pharmaceuticals Inc. and Sanofi Pasteur.
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