The history of the newer quinolone agents began with the discovery of nalidixic acid in 1962. This ultimately led to the development of many newer quinolones, some of which have unique properties.
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New formulation: Once daily administration for continuous Tx of chronic moderate-to-severe pain
New indication: Long-term, twice-daily treatment of bronchospasm associated with COPD
New indication: For delaying relapse in long-term treatment of schizophrenia
New Indication: Antiplatelet approved for acute coronary syndrome
Bristol-Myers Squibb has issued a "Dear Healthcare Provider" letter and revised labeling to inform of the potential for lactic acidosis and severe hepatomegaly with steatosis-including some fatal cases-when nucleoside analogue therapy is used alone or in combination with other antiretrovirals
Merck has issued revised labeling for its COX-2 inhibitor rofecoxib (Vioxx) that incorporate findings from the 8,000-patient VIGOR (Vioxx Gastrointestinal Outcomes Research) study.
New contraindications and precautions have been added to the labeling of methylphenidate HCl tablets (Ritalin and Ritalin-SR, Novartis)-approved for treatment of attention deficit/hyperactivity disorder (ADHD).
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Enoxaparin sodium (Lovenox injection, Aventis) is not recommended for thromboprophylaxis in patients with prosthetic heart values and particularly in pregnant women with prosthetic heart valves, according to revised product labeling.
A new black box warning has been added to the labeling of all interferon alfa products (Intron A, Rebetron, Roferon-A).
Pfizer has issued a "Dear Healthcare Professional" letter to clarify and strengthen contraindications with its antipsychotic agent ziprasidone HCl (Geodon).
From Consumer Advocy Groups:Public Citizen urges ban on Arava. . . According to Public Citizen, 130 cases of severe liver toxicity-including 56 hospitalizations and 12 deaths-have been reported to the FDA since the 1998 introduction of rheumatoid arthritis agent leflunomide (Arava). This equates to six times the number of cases of fatal liver toxicity seen with methotrexate, although 5.5 times more prescriptions for methotrexate were filled over the 3-year comparative period. Public Citizen also says that leflunomide has been associated with 12 cases of Stevens-Johnson syndrome (compared with none reported with methotrexate) and more reports of lymphoma and hypertension.
Ratherthan shortening the hospital stay and improving clinical outcomes, a 48-hour infusion of milrinone was associated with increased early treatment failure-particularly due to the development of arrhythmias and hypotension-in patients hospitalized with acute exacerbations of chronic heart failure (CHF).
as reported May 1, 2002
Enoxaparin (Lovenox) is typically used during hospitalization after orthopedic or abdominal surgery. Recent studies of its use after orthopedic surgery have shown that extending administration of the low-molecular-weight heparin after hospital discharge significantly reduces the frequency of deep-vein thrombosis (DVT). A new study confirms this is also the case for abdominal surgery for cancer, which carries a high risk of this complication.
Neither extracts of Hypericum perforatum (St. John's Wort) nor sertraline (Zoloft) tested in patients with major depressive disorder performed better than placebo in reducing patients' scores on a standard assessment of depression severity.
The investigational vasopeptidase inhibitor omapatrilat is as effective as enalapril in preventing major adverse cardiac outcomes in patients with moderate to severe heart failure, but failed to show superiority, said Milton Packer, MD.
LIPS: Statin reduces cardiac event risk by 22% in first PCI procedureAzithromax ineffective for reducing recurrent CV events
Even when very elderly (age 80 years and older)patients have no contraindications to thrombolytic therapy, treatment withthese drugs can increase their risk of death.
as reported May 1, 2002
Drug therapy to control heart rate is at least as effective as antiarrhythmicdrug therapy in preventing adverse clinical events in patients with atrialfibrillation (AF), according to separate studies.
Therapy starting with the angiotensin receptor blocker (ARB) losartansignificantly reduced the risk of cardiovascular outcomes and new-onsetdiabetes compared with a beta blocker in older high-risk hypertensive patients,said Björn Dahlöf, MD. The improved outcomes with losartan occurredeven after adjusting for small differences in blood pressure reduction betweenthe two study drugs.
Atlanta-The low-molecular-weight heparin enoxaparin improves outcomes compared with currently recommended therapy in patients with non-ST-segment elevation acute coronary syndromes (ACS) who are being treated with a glycoprotein (GP) IIb/IIIa inhibitor, said Shaun Goodman, MD.
Lercanidipine is currently under FDA review for the management of hypertension. In comparative clinical trials, lercanidipine has shown antihypertensive efficacy comparable to that of slow-release nifedipine, amlodipine, nitrendipine, verapamil, captopril, and atenolol. Its side effect profile is similar or superior to these agents. This Focus article reviews those trials as well as lercanidipine?s pharmacologic properties and addresses the agent?s potential role in patients with comorbid conditions.
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