FDA Approves FRAGMIN(R) Once-Daily Post-Operative
Dosing for Prevention of Deep Vein Thrombosis Following Hip
Replacement Surgery
PR Newswire - August 07, 2000 07:15
FRAGMIN First and Only Low Molecular Weight Heparin Approved for Once-Daily Post-Operative
Dosing
PEAPACK, N.J., Aug. 7 /PRNewswire/ -- Pharmacia Corporation (NYSE: PHA) announced today that
the U.S. Food and Drug Administration (FDA) has approved a post-operative once-daily dosing regimen
for the anti-clotting agent FRAGMIN(R) (dalteparin sodium injection) for the prevention of blood clots
(known as deep vein thrombosis) following hip replacement surgery. FRAGMIN is the first and only low
molecular weight heparin (LMWH) approved for this dosing regimen. The study supporting the approval
showed that FRAGMIN administered in the post-operative period following hip replacement surgery was
more effective than warfarin -- a standard treatment -- in preventing deep vein thrombosis. More than
280,000 people undergo hip replacement each year, with potentially fatal blood clots occurring in up to 60
percent of these patients, if left unprotected.
"Doctors would prefer to give anticoagulation therapy in the post-operative period after hip replacement
rather than before surgery to reduce the risk of bleeding due to anticoagulation effects during surgery," said
David C. Ayers, MD, director of joint replacement surgery and associate professor of orthopedic surgery,
Upstate Medical University, Syracuse, NY. "FRAGMIN given post-operatively provided the efficacy in
reducing blood clots that physicians want, and demonstrated a low incidence bleeding."
Pivotal Data Supporting Dosing
The revision to the product's label allows physicians to initiate the once-daily dose (within four to eight
hours) post-operatively, and continue treatment for up to 14 days (usual duration was five to 10 days). The
landmark multi-center, double-blind, randomized study, North American FRAGMIN Trial (NAFT),
evaluated the incidence of deep vein thrombosis in 1,472 patients treated with FRAGMIN(R) started either
pre-operatively or post-operatively, or warfarin, for six days. Results showed that initiating the first dose of
FRAGMIN post-operatively was as effective in reducing the risk of deep vein thrombosis as FRAGMIN
dosed pre-operatively. Both dosing regimens were more effective than warfarin in reducing the incidence of
thromboembolic events following hip replacement surgery. The incidence of deep vein thrombosis in both
groups treated with FRAGMIN was lower than in patients receiving warfarin (13.1% post-operative,
10.7% pre-operative, 24% warfarin). There was a relative risk reduction of 72 percent in proximal deep
vein thrombosis (0.8% post-operative, 0.8% pre-operative, 3% warfarin) and a 45 percent relative risk
reduction in total deep vein thrombosis with FRAGMIN post-operative dosing versus warfarin. Proximal
deep vein thrombosis, clots in blood vessels in the upper legs or pelvis, is associated with a greater risk of
pulmonary embolism, which reduces the patient's oxygenated blood flow to the heart and brain, and can
cause death. The incidence of investigator reported serious bleeding events was similar in all three treatment
groups (1.0% post-operative, 2.0% pre-operative, 1.6% warfarin).
More About FRAGMIN(R) and Deep Vein Thrombosis
Deep vein thrombosis affects up to 60 percent of patients who undergo hip replacement surgery without
preventative therapy. It occurs when blood clots form in a vein in the pelvis or legs; in some cases the clot
can dislodge and travel to the lung arteries, resulting in pulmonary embolism.
More than 40 million patients worldwide have received low molecular weight heparin (LMWH)
FRAGMIN.
FRAGMIN is contraindicated in patients with active major bleeding or a known hypersensitivity to the drug
or active major bleeding, and should be used with extreme caution in patients with history of
thrombocytopenia (low platelet count) or with an increased risk of hemorrhage. Spinal or epidural
hematomas can occur with the associated use of low molecular weight heparins or heparinoids and
neuraxial anesthesia or spinal puncture, which can result in long-term or permanent paralysis.
About Pharmacia Corporation
Pharmacia Corporation (NYSE: PHA) is a leading global pharmaceutical company created through the
merger of Pharmacia & Upjohn with Monsanto Company and its G.D. Searle unit. Pharmacia has a broad
product portfolio, a robust pipeline of new medicines, and makes an annual investment of more than $2
billion in pharmaceutical research and development.
Certain statements contained in this release, such as statements concerning the Company's anticipated
financial results, current and new product performance, regulatory approvals, currency impact and other
non-historical facts are "forward-looking statements" (as such term is defined in the Private Securities
Litigation Reform Act of 1995). Since these statements are based on factors that involve risks and
uncertainties, actual results may differ materially from those expressed or implied by such forward- looking
statements. Such factors include, among others: management's ability to implement -- strategic initiatives;
the Company's ability to successfully market new and existing products in new and existing domestic and
international markets; the success of the Company's research and development activities and the speed with
which regulatory authorizations and product roll-outs may be achieved; fluctuations in exchange rates; the
effects of the Company's accounting policies and general changes in generally accepted accounting
principles; the Company's exposure to product liability and other lawsuits and contingencies related to
actual or alleged environmental contamination; domestic and foreign social, legal and political
developments, especially those relating to health care reform and product liabilities; general economic and
business conditions; the Company's ability to attract and retain current management and other employees of
the Company; and other risks and factors detailed in the Company's Securities and Exchange Commission
filings, including its Proxy Statement and Form 10-K for the year ended December 31, 1999.
SOURCE Pharmacia Corporation
/CONTACT: Karen Carolonza, Media Contact, 908-901-8515, or e-mail
karen.s.carolonza@am.pnu.com; or Craig Tooman, Analyst Contact, 908-901-8853,
or e-mail craig.tooman@am.pnu.com, both of Pharmacia Corporation/
/Company News On-Call: prnewswire.com or fax,
800-758-5804, ext. 884150/
/Web site: pnu.com
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Another victory in a niche market.
Jack |
