FDA Advisory Committee Reviews

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ALSO IN THIS ISSUE:NEWSMEMBER NEWSUSER SUPPORT

NEW FEATURES THIS WEEK

In the Pipeline: FDA Advisory Committee Reviews

The US Food and Drug Administration (FDA) convenes public advisory committee meetings to address issues in new drug applications (NDAs), biologics license applications (BLAs), or clinical trials that are currently under FDA review.AdComm Bulletin 1(11) 2003

Preventable Adverse Events Decline When Pharmacist Joins General Medicine Rounds

Seventy-eight percent fewer preventable adverse drug events (ADEs) occurred among patients in a hospital's general medicine unit when a pharmacist participated in weekday medical rounds, researchers recently reported in the Archives of Internal Medicine.Am J Health-Syst Pharm 60(22) 2003

Evolution and Operation of a Pharmacy Residency On-Call Program

A pharmacy residency is "organized, directed, postgraduate training in a defined area of pharmacy practice."Am J Health-Syst Pharm 60(21) 2003

Conference Report - II. Investigating New Vaccines: SARS

Sophisticated coronavirus vectors are being refined for use as SARS vaccines.Medscape General Medicine 5(4) 2003

Counseling Patients About Complications of Diabetes

The World Health Organization has stated that diabetes mellitus is at an epidemic level.US Pharmacist 28(11) 2003

ASHP Therapeutic Position Statement on Strict Glycemic Control in Patients With Diabetes

The American Society of Health-System Pharmacists (ASHP) supports strict glycemic control in all appropriate patients with diabetes mellitus.Am J Health-Syst Pharm 60(22) 2003

Exploring the Association Between Atypical Neuroleptic Agents and Diabetes Mellitus in Older Adults

Since their introduction in the late 1980s, the atypical neuroleptic agents-clozapine, olanzapine, quetiapine, and risperidone-have had a profound impact on the management of schizophrenia.Pharmacotherapy 23(11) 2003

Toward Optimal Health: The Experts Discuss the Use of Botanicals by Women

Botanicals are increasingly popular and are used more widely by women than men, particularly

women in their middle and advancing ages.J Womens Health 12(9) 2003

Rhabdomyolysis Associated With Simvastatin-Nefazodone Therapy

A 56-year-old white man with a history of hyperlipidemia, coronary artery disease, erectile dysfunction, allergic rhinitis, and sinusitis presented to his primary care provider complaining that he was having problems with impotence and depression.South Med J 96(10) 2003

Wood Creosote, the Principal Active Ingredient of Seirogan, an Herbal Antidiarrheal Medicine: A Single-Dose, Dose-Escalation Safety and Pharmacokinetic Study

Diarrhea is recognized as a major health problem and one of the leading causes of infant mortality in developing countries.Pharmacotherapy 23(11) 2003

Hospital Pharmacy Directors' Perceptions of Hospital Mergers and Strategic Alliances

Throughout the 1990s, mergers and strategic alliances (MSAs) were frequent among hospitals.Am J Health-Syst Pharm 60(21) 2003

Comparison of Changes in Blood Pressure Measurement and Antihypertensive Therapy in Older, Hypertensive, Ambulatory Care Patients Prescribed Celecoxib or Rofecoxib

Cyclooxygenase (COX)-2 inhibitors are commonly administered in ambulatory care settings to treat pain and arthritis.Pharmacotherapy 23(11) 2003

Maternal Haloperidol Therapy Associated With Dyskinesia in a Newborn

The use of antipsychotic medications in pregnancy poses a dilemma for patients and practitioners.Am J Health-Syst Pharm 60(21) 2003

FOCUS ON ACID-RELATED DISORDERS

The use of PPIs has dramatically altered management of acid-peptic disorders. Cash, MD, discusses latest findings on clinical applications and outcomes associated with use of both IV and oral

PPIs, in "Proton-Pump Inhibitors: Clinical Applications," a featured

conference report in the Gastroesophageal Reflux Disease Resource

Center.

NEWS

Attention Deficit Drugs May Have Long-Term Effects

If rat studies are any indication, drugs given to children to treat attention deficit hyperactivity disorder could have long-term effects on their growing brains.Reuters Health Information 2003

AMA to Study Ways to Limit Pharma Access to Individual MD Prescribing Data

The American Medical Association's House of Delegates wants the AMA board of trustees to develop policy aimed at blocking release of physician prescribing information to pharmaceutical companies that use the information to "profile" physicians' prescribing habits.Reuters Health Information 2003

Older Americans to Get Drug Discount Card in 2004

Older Americans could get new Medicare-approved drug discount cards as early as next April or May, slightly ahead of the June deadline for the first phase of the new Medicare prescription drug benefit, Health and Human Services Secretary Tommy said on Tuesday.Reuters Health Information 2003

EU Court Backs Online Non-Prescription Drug Sales

The European Union's top court ruled on Thursday that Germany cannot ban the online sale or postal delivery of non-prescription drugs, finding partly in favor of a Dutch-based pharmacist selling over the Internet.Reuters Health Information 2003

Flu Spreading in U.S. but Not Serious Yet: CDC

The flu is spreading across the United States and the government is concerned enough to buy up 250,000 available doses of vaccine to make sure it goes to those who need it most, officials said on Thursday.Reuters Health Information 2003

Borage Oil Not Helpful for Atopic Dermatitis

In a randomized, double-blind trial, this oil was of no benefit, supporting speculation that the same is true for evening primrose, another source of gamma linolenic acid. Medscape Medical News 2003

U.S. Government Goes on Hunt for Flu Vaccine

U.S. government officials said on Tuesday they are searching for alternative supplies of influenza vaccine and monitoring whether shortages are putting patients in danger.Reuters Health Information 2003

Glaxo, Boehringer Allow More Generic AIDS Drugs

South Africa moved closer to bringing AIDS treatment to millions of its poor Wednesday after two drug giants said they would allow more cheap generic versions of patented drugs to be made.Reuters Health Information 2003

Lipoproteins May Be Protective in Chronic Heart Failure

Higher levels of total cholesterol are associated with increased survival in patients with chronic heart failure (HF), new study results suggest. But as yet, there is little evidence to suggest that lipid-lowering drugs are either beneficial or deleterious in patients with HF.Reuters Health Information 2003

Benefits of Inhaled Corticosteroids for Asthma Outweigh Risks

A consensus statement by the ACCP, AAAAI, and ACAAI evaluated the evidence of benefit and harm and concluded that ICS should remain the gold standard of asthma treatment.Medscape Medical News 2003

HCQ Treatment Is Safe in Pregnant Women With Connective Tissue Diseases

Hydroxychloroquine (HCQ) therapy appears to be safe in pregnant women with systemic lupus erythematosus (SLE), according to researchers.Reuters Health Information 2003

Zidovudine, Lamivudine, and Efavirenz Best Initial Therapy for HIV-1 Infection

Results of two randomized trials suggest that this triple therapy is superior to other antiretroviral regimens.Medscape Medical News 2003

Long-Acting Naltrexone Cuts Drinking in Alcoholic Men, but Not Women

Alkermes Inc. on Monday said its experimental treatment for alcoholism reduced the rate of drinking in men by nearly half in a late-stage clinical trial. It did not work in women.Reuters Health Information 2003

Gleevec May Treat Leukemias Other Than CML

Imatinib (Gleevec/Glivec), which has produced striking results in patients with chronic myeloid leukemia (CML), may also help some patients with another form of leukemia which is hard to treat, U.S. researchers reported on Tuesday.Reuters Health Information 2003

US FDA Panel Against Approving Broader Aspirin Use

A U.S. advisory panel on Monday voted 11-3 against a Bayer Corp. proposal to approve broader use of aspirin to protect the hearts of patients who have not had a heart attack.Reuters Health Information 2003

Low-Dose Interferon Does Not Improve Survival of High-Risk Melanoma

As adjuvant therapy for completely resected high-risk melanoma, low-dose interferon does not seem to improve survival, according to a UK study. Reuters Health Information 2003

FTC Issues List of Bogus Weight-Loss Claims

The U.S. Federal Trade Commission on Tuesday escalated its campaign against phony weight-loss advertising, issuing a list of false claims that it said should be banned by the media.Reuters Health Information 2003

Nicotine Patch May Improve Attention in Age-Associated Memory Impairment

In a double-blind, placebo-controlled study, chronic transdermal nicotine caused a sustained improvement in clinical symptoms and objective computerized tests of attention.Medscape Medical News 2003

Fracture Risk Increases Rapidly With Start of Glucocorticoid Therapy

In postmenopausal women with similar baseline levels of bone mineral density (BMD), users of oral glucocorticoids (GCs) have significantly higher fracture risks than nonusers, a new study indicates. Reuters Health Information 2003

Thiazolidinediones Contraindicated in Patients at Risk for Heart Failure

A joint statement from the American Heart Association and the American Diabetes Association notes reports of CHF and edema associated with these drugs.Medscape Medical News 2003

Bush Signs Medicare Bill, Democrats Vow New Battle

U.S. President W. Bush on Monday signed a $400 billion overhaul of the Medicare old-age health system that adds prescription drug coverage, but Democrats who say the bill is inadequate vowed a new battle to "take back our Medicare."Reuters Health Information 2003

Pamidronate May Worsen Secondary Hyperparathyroidism in Dialysis Patients

Secondary hyperparathyroidism in postmenopausal dialysis patients may be aggravated by the bisphosphonate pamidronate, according to a report published in the December issue of the American Journal of Kidney Diseases. Reuters Health Information 2003

Long-Acting Implants May Be Effective Male Contraceptive

After a single administration, the 7-alpha-methyl-19-nortestosterone implants inhibited spermatogenesis in some men for a prolonged period.Medscape Medical News 2003

FDA Approves Risperdal for Bipolar Disorder

& on Friday said the U.S. Food and Drug Administration has approved its antipsychotic drug, Risperdal (risperidone), to treat bipolar disorder.Reuters Health Information 2003

Rasburicase Effective for Tumor Lysis Syndrome

Adult patients at high risk responded to rasburicase and tolerated it well, leading investigators to suggest it should be the treatment of choice.Medscape Medical News 2003

Fluoxetine Added to Olanzapine Improves Treatment of Bipolar Depression

Coadministration of fluoxetine with olanzapine significantly enhances the effects of monotherapy, without increasing the likelihood of emergent mania.Reuters Health Information 2003

Fentanyl Patch Safe, Effective for Long-Term Relief of Cancer Pain

The transdermal therapeutic system-fentanyl (TTS-F) is a safe and effective long-term analgesic option for moderate to severe cancer pain, both in patients who have previously been given oral morphine and those who have not, according to results of a study conducted in Greece.Reuters Health Information 2003

Levetiracetam Effective Monotherapy for Epilepsy

Growing evidence supports off-label use of the drug in adult and elderly epileptics.Medscape Medical News 2003

MabThera Study in Lymphoma Halted Early Because of Good Results

A clinical trial of MabThera in treating the aggressive form of non-Hodgkin's lymphoma (NHL) in patients younger than 60 has been halted two years early due to significant efficacy benefits, Roche Holding AG said on Monday.Reuters Health Information 2003

Imatinib Should Be Tried for Six Months in Chronic Myeloid Leukemia

Patients with chronic myeloid leukemia that is unresponsive to imatinib after 3 months of treatment might yet show a favorable response if they continue on it. But after about 6 months of no response, other therapies should be considered, researchers said at the American Society of Hematology meeting here.Reuters Health Information 2003

Rituximab Increases Time to Progression for Lymphoma Patients

The addition of rituximab to the CHOP regimen results in a 47% reduction in risk of time to progression or death from any cause.Medscape Medical News 2003

Aspirin Decreases Thrombotic Event Frequency in Polycythemia Vera Patients

A low dose decreases the risk of stroke, thromboses, and death in this patient cohort. Medscape Medical News 2003

Adenoviral-Based SARS Vaccine Shows Promise in Macaques

U.S. researchers have created a vaccine based on surface antigens of the SARS coronavirus and delivered by a modified adenovirus that can induce a strong, specific immune response in rhesus macaques. Human clinical trials are being planned in the "near future."Reuters Health Information 2003

Hepatitis A/B Vaccination Cost-Effective for STD Clinic Attendees

Replacing hepatitis B vaccine with a vaccine active against hepatitis A and B at U.S. sexually transmitted disease clinics would provide the additional protection in a cost-effective manner, investigators report. A hepatitis A/B vaccine is available and is administered on the same schedule as hepatitis B vaccine.Reuters Health Information 2003

DHEA Increases Foam Cell Formation

Dehydroepiandrosterone (DHEA), a supplement popular with men for its possible anti-aging effects, seems to increase macrophage foam cell formation in vitro, Australian researchers report. This means it could raise the risk of atherosclerotic disease.Reuters Health Information 2003

Triple Therapy Better Than Mixed Insulin for Obese Type 2 Diabetics

In a randomized trial, combining rosiglitazone, metformin, and insulin aspart improved glucose metabolism compared with mixed insulin.Medscape Medical News 2003

Anti-CD4 Monoclonal Antibody Safely Reduces Severity and Extent of Psoriasis

Treatment with a fully human monoclonal anti-CD4 antibody appears to be a safe, moderately effective treatment for psoriasis, according to a report published in the November issue of the Archives of Dermatology.Reuters Health Information 2003

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