CINCINNATI and BRIDGEWATER, N.J., April 24 -
The U.S. Food and Drug Administration (FDA) approved a new once-a-month
dose (150 mg) of Actonel(R) (risedronate sodium) tablets for the treatment
and prevention of postmenopausal osteoporosis. Actonel is approved to
reduce the risk of fractures in postmenopausal women with osteoporosis.
The FDA approval of the once-a-month dose is based on a study comparing
Actonel 150 mg once monthly to Actonel 5 mg daily. Similar increases in
bone mineral density (BMD) were seen among patients taking either
once-a-month or daily dosing regimens.
Over fifty-five million prescriptions of Actonel have been filled in
the U.S. alone since its approval for osteoporosis in 2000. Those who want
to learn more about postmenopausal osteoporosis and treatment with Actonel
should visit: http://www.Actonel.com.
About Osteoporosis
Postmenopausal osteoporosis is a silent disease that affects millions
of 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 fractures.
About Actonel
Actonel is contraindicated in patients with hypocalcemia, known
hypersensitivity to any component of this product, or inability to stand or
sit upright for at least 30 minutes. Hypocalcemia and other disturbances of
bone and mineral metabolism should be effectively treated before starting
Actonel therapy. Actonel is not recommended for use in patients with severe
renal impairment (creatinine clearance < 30 mL/min).
Bisphosphonates, including Actonel, may cause upper gastrointestinal
disorders such as dysphagia, esophagitis and esophageal or gastric ulcers.
Actonel should be taken according to the dosing instructions to minimize
the risk of these events. Patients should discontinue use if new or
worsening symptoms occur.
There have been reports of severe and occasionally incapacitating bone,
joint and/or muscle pain in patients taking bisphosphonates. Rare
occurrences of osteonecrosis, primarily of the jaw (ONJ), have been
reported in patients treated with bisphosphonates. Most cases were reported
in cancer patients receiving intravenous bisphosphonates, but some have
been in patients treated orally for osteoporosis. Most cases were reported
in patients undergoing dental procedures such as tooth extraction.
Most common adverse reactions reported in >10% of patients treated with
ACTONEL and with a higher frequency than placebo are: back pain,
arthralgia, abdominal pain, and dyspepsia. Hypersensitivity reactions
(angioedema, generalized rash, bullous skin reactions), and eye
inflammation (iritis, uveitis) have been reported rarely.
Please see full prescribing information for Actonel(R) (risedronate
sodium) tablets for additional safety information. For more information on
Actonel please visit http://www.Actonel.com.
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed in May 1997 to promote
bone health and disease awareness through numerous activities to support
physicians and patients around the globe. It is a collaboration between
Procter & Gamble Pharmaceuticals and sanofi-aventis U.S.
About Procter & Gamble (NYSE: PG)
Three 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), Mach3(R), Bounty(R), Dawn(R),
Pringles(R), Folgers(R), Charmin(R), Downy(R), Lenor(R), Iams(R), Crest(R),
Oral-B(R), Actonel(R), Duracell(R), Olay(R), Head & Shoulders(R), Wella,
Gillette(R), and Braun. The P&G community consists of over 135,000
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
Sanofi-aventis, a leading global pharmaceutical company, discovers,
develops and distributes therapeutic solutions to improve the lives of
everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York
(NYSE: SNY).
For P&G: All statements, other than statements of historical fact
included in this release, are forward-looking statements, as that term is
defined in the Private Securities Litigation Reform Act of 1995. Such
statements are based on financial data, market assumptions and business
plans available only as of the time the statements are made, which may
become out of date or incomplete. We assume no obligation to update any
forward-looking statement as a result of new information, future events or
other factors. Forward- looking statements are inherently uncertain, and
investors must recognize that events could differ significantly from our
expectations. In addition to the risks and uncertainties noted in this
release, there are certain factors that could cause actual results to
differ materially from those anticipated by some of the statements made.
These include: (1) the ability to achieve business plans, including with
respect to lower income consumers and growing existing sales and volume
profitably despite high levels of competitive activity, especially with
respect to the product categories and geographical markets (including
developing markets) in which the Company has chosen to focus; (2) the
ability to successfully execute, manage and integrate key acquisitions and
mergers, including (i) the Domination and Profit Transfer Agreement with
Wella, and (ii) the Company’s merger with The Gillette Company, and to
achieve the cost and growth synergies in accordance with the stated goals
of these transactions; (3) the ability to manage and maintain key customer
relationships; (4) the ability to maintain key manufacturing and supply
sources (including sole supplier and plant manufacturing sources); (5) the
ability to successfully manage regulatory, tax and legal matters (including
product liability, patent, and intellectual property matters as well as
those related to the integration of Gillette and its subsidiaries), and to
resolve pending matters within current estimates; (6) the ability to
successfully implement, achieve and sustain cost improvement plans in
manufacturing and overhead areas, including the Company’s outsourcing
projects; (7) the ability to successfully manage currency (including
currency issues in volatile countries), debt, interest rate and commodity
cost exposures; (8) the ability to manage continued global political and/or
economic uncertainty and disruptions, especially in the Company’s
significant geographical markets, as well as any political and/or economic
uncertainty and disruptions due to terrorist activities; (9) the ability to
successfully manage competitive factors, including prices, promotional
incentives and trade terms for products; (10) the ability to obtain patents
and respond to technological advances attained by competitors and patents
granted to competitors; (11) the ability to successfully manage increases
in the prices of raw materials used to make the Company’s products; (12)
the ability to stay close to consumers in an era of increased media
fragmentation; (13) the ability to stay on the leading edge of innovation
and maintain a positive reputation on our brand; and (14) the ability to
successfully separate the company’s coffee business. For additional
information concerning factors that could cause actual results to
materially differ from those projected herein, please refer to our most
recent 10-K, 10-Q and 8-K reports.
SOURCE The Alliance for Better Bone Health