Forest Pharmaceuticals is marketing Celexa (citalopram HBr)
in a new 10mg tablet. This beige, oval, film-coated tablet joins
the 20mg and 40mg tablets previously available.
COX-2 Inhibitor
Pharmacia and Pfizer are co-marketing a new COX-2 inhibitor, Bextra
(valdecoxib) for the treatment of osteoarthritis (OA), rheumatoid
arthritis (RA) and dysmenorrhea. Adverse effects include dyspepsia,
nausea, abdominal pain, diarrhea, headache and peripheral edema.
Valdecoxib can increase warfarin levels and should be used with caution in
patients with impaired renal function, fluid retention, hypertension or
edema. Just as with other COX-2 inhibitors, valdecoxib can cause serious
GI toxicity, including bleeding, ulceration and perforation, although less
likely than with traditional NSAIDs. The recommended dose for OA and RA is
10mg daily with or without food. The dose for primary dysmenorrhea is 20mg
twice daily as needed. Although no indication was approved for acute
pain, Pharmacia intends to pursue this indication in the future. Bextra
is available in 10mg and 20mg tablets.
Long-Acting
Erythropoietin
Amgen has FDA approval to market Aranesp (darbepoetin alfa),
a novel colony-stimulating factor for the treatment of anemia caused by
chronic renal disease with or without dialysis. Amgen has also filed for
approval of darbepoetin for the treatment of chemotherapy-related anemia.
Darbepoetin, like endogenous and recombinant erythropoietin (EPO), acts on
erythroid progenitor cells to stimulate red blood cell production. It has
a half-life two to three times longer than EPO, requiring fewer injections
than current treatments. Darbepoetin should be administered intravenously
or subcutaneously once weekly with a starting dose of 0.45mcg/kg and once
every two weeks to patients currently taking epoetin once weekly. As with
EPO, it may be important for patients to take iron supplements. The most
commonly reported side effects included infection, hypertension,
hypotension, myalgia, headache and diarrhea. Patients with chronic renal
failure may need to begin or increase the dosage of antihypertensive
drugs. Aranesp is available in single-dose vials of 25mcg, 40mcg,
60mcg, 100mcg and 200mcg and should be stored under refrigeration and
protected from light.
Antithrombin
Therapy
Sanofi-Synthelabo and Organon have received FDA approval for Arixtra
(fondaparinux sodium) injection, the first synthetic anticoagulant
indicted for reducing the risk of blood clots after orthopedic surgery. Arixtra
is a pentasaccharide that selectively inhibits Factor Xa. As with other
anticoagulants, the major adverse effect is dose-related bleeding.
Fondaparinux has no impact on the effect of warfarin on INR, but
concurrent aspirin therapy may enhance the antithrombotic effects of each
agent or increase the risk of bleeding. It is contraindicated in patients
with severely impaired kidney function and those weighing less than 110
pounds.
New Strengths
Available
Aventis Pharmaceuticals has introduced two new strengths of Lovenox
(enoxaparin sodium) syringes to simplify drug delivery. The new prefilled,
graduated syringes contain a higher concentration of enoxaparin, 150mg/ml
and are available in 120mg and 150mg strengths. They join
the 30mg, 40mg, 60mg, 80mg and 100mg syringes with a concentration of
100mg/ml previously available. Introduction of the new strengths
co-insides with a once-a-day dosing option that is now available for the
following indications: hip-replacement surgery, extended prophylaxis in
hip replacement, abdominal surgery patients at risk for thromboembolic
complications, medical patients with severely restricted mobility during
acute illness at risk for thromboembolic complications and treatment of
DVT with or without PE in conjunction with warfarin therapy during
hospitalization.
