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DRUG Information: FDA new and generic drug = approvals, June 1-July 1, 2004

Drug = Information: recent additions to the Drugs.com database
Advate, Alimta, Caduet, Ertaczo, Prevacid NapraPAC, = Riomet, Risperdal Consta, Spiriva, Symbyax, Zorbtive. go...

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FDA = approves Vioxx for once-daily treatment of juvenile rheumatoid = arthritis...

FDA = approves antidepressant Cymbalta for treatment of pain caused by = diabetic peripheral neuropathy...

Rhinocort Aqua pregnancy rating upgraded to Category B = for allergic rhinitis treatment...

Atypical = antipsychotic Geodon approved for acute bipolar mania treatment without = significant weight gain...

FDA = updates its review of antidepressant drugs in = children...

FDA = approves Topamax for migraine prophylaxis...

U.S. = approval for Adderall XR to treat adults...

New = OptiClik insulin pen system approved for once-daily Lantus = injections...

FDA = approves drugs to treat internal contamination from radiation accidents = and ’dirty bombs’...

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Warning on hyperglycemia and diabetes risks for Geodon and = similar medications
FDA and Pfizer notified healthcare = professionals of revision to the WARNINGS section of labeling for Geodon = (ziprasidone), describing the risk of hyperglycemia and diabetes in = patients taking Geodon. FDA asked all manufacturers of atypical = antipsychotic medications, including Pfizer, to add this Warning = statement to labeling. Safety Summary, links to letter and revised = label, here...

Remicade labeling revised after reports of hematologic = events (some fatal)
FDA and Centocor revised the WARNINGS and = ADVERSE REACTIONS sections of the labeling for Remicade = (infliximab), indicated for the treatment of rheumatoid arthritis and = Crohn’s disease. Cases of leukopenia, neutropenia and = pancytopenia, some with fatal outcome, and cases of CNS manifestation of = systemic vasculitis, were described in patients receiving Remicade. The = ADVERSE REACTIONS section was updated to include neutropenia, = pericardial effusion and systemic and cutaneous vasculitis. Safety = Summary, links to letter and revised label, here...

Lovenox labeling revision describes dosage adjustment for = patients with severe renal impairment
FDA and Aventis = Pharmaceuticals revised the CLINICAL PHARMACOLOGY, PRECAUTIONS, and = DOSAGE AND ADMINISTRATION sections of labeling for Lovenox (enoxaparin = sodium injection), describing the need for a dosage adjustment for = patients with severe renal impairment (creatinine clearance = <30mL/min) who have increased exposure to enoxaparin. No specific = dosage adjustment is required in patients with mild or moderate renal = impairment and in low-weight patients. However, low-weight patients = should be observed carefully for signs and symptoms of bleeding. Safety = Summary, links to March 2004 letter and July 2004 label, here...

Avastin: Important warning on increased risk of serious = arterial thromboembolic events
FDA and Genentech, Inc. issued an = important drug warning to healthcare providers that there is evidence of = an increased risk of serious arterial thromboembolic events, including = cerebrovascular accident, myocardial infarctions, transient ischemic = attacks, and angina related to Avastin = (bevacizumab). The risk of fatal arterial thrombotic events is also = increased. In randomized, active-controlled studies conducted in = patients with metastatic colorectal cancer, the risks of a serious = arterial thrombotic event was approximately two-fold higher in patients = receiving infusional 5-FU based chemotherapy plus Avastin, with an = estimated overall rate of up to 5%. A revised Avastin package insert = containing more detailed information on arterial thromboembolic events = is in development. Safety Summary, links to letter and current Avastin = package insert, here...

 
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