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Sedative-hypnotic drug products

2007-03-26

FDA notified healthcare professionals and consumers of its request that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.


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Long-Term Aspirin Use Associated with Reduced Risk of Dying in Women

2007-04-25

Women who take low to moderate doses of aspirin have a reduced risk of death from any cause, and especially heart disease–related deaths, according to a report in the March 26 issue of Archives of Internal Medicine.
Some studies have provided evidence that aspirin may reduce the risk of heart disease and some types of cancer, the two leading causes of death in U.S. women, according to background information in the article. However, it is unclear whether aspirin reduces the risk of death overall for women.


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Naltrexone cream helps alleviate chronic itching

2007-07-03

NEW YORK (Reuters Health) - The application of naltrexone, an "opiate receptor antagonist," to the skin is significantly more effective than placebo in relieving chronic itching, also know as pruritus, in patients with allergic dermatitis, Swiss and German researchers report in the June issue of the Journal of the American Academy of Dermatology.

Naltrexone, also known under the trade names Depade and ReVia, is approved by the US Food and Drug Administration to help patients with addition, by blocking the effects of the drugs.


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Selenium supplement no help in asthma

2007-07-03

NEW YORK (Reuters Health) - Even though selenium levels seem to be low in adults with asthma, selenium supplementation appears to have no clinical benefit, according to the results of a study from the UK.


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Long-Acting Insulin Glargine Significantly Lowers Free Fatty Acids

2007-07-04

The long-acting insulin glargine (Lantus, Sanofi Aventis, Bridgewater, NJ) has lipid-lowering effects that investigators believe are independent of its effect on blood sugar, according to results of two trials presented at the 67th Scientific Sessions of the American Diabetes Association in Chicago.

Dr. Sherwyn Schwartz of the Diabetes and Glandular Disease Clinic of San Antonio, TX, reported on 165 type 2 diabetics assigned to glargine therapy and 182 patients to a thiazolidinediones plus pioglitazone add-on therapy for 24 weeks.


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SSRIs Increase Bone Loss in Older Adults

2007-07-04

Two cohort studies — one in older women and the other in older men — find increased bone loss associated with SSRI use.

The studies, published in Archives of Internal Medicine , included some 2700 women and 6000 men followed prospectively in population-based studies of osteoporosis. Participants had their medications inventoried and their BMD measured. The women underwent two measurements of BMD, done roughly 5 years apart; the men had a single measurement.


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The FDA Revised Safety Information for Xolair

2007-07-04

Genetech and FDA informed healthcare professionals and asthmatic patients in the united state that the prescribing information for Xolair was revised to include a new BOXED WARNING, and updated WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections that address the risk of anaphylaxis (the onset of action can be delayed for 24 hours or more) when taking this medication. In addition, a new MEDICATION GUIDE was developed and will be provided to patients when a prescription for Xolair is filled or refilled at the pharmacy.


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European Medicines Agency recommends Acomplia must not be used in patients on antidepressants or with major depression

2007-07-21

The European Medicines Agency (EMEA) today recommended contraindicating Acomplia
(rimonabant) from sanofi-aventis, in patients with ongoing major depression or who are being treated with antidepressants, because of the risk of psychiatric side effects. Doctors in the EU have already been warned about this since June 2006 but the Agency’s Committee for Medicinal Products for Human Use (CHMP) has now recommended upgrading this warning.


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High Dose Statins cuts heart risk in elderly

2007-07-24

In a recent double blind clinical study performed in 256 different sites from over 14 countries participating in the Treating to New Targets study suggested that additional clinical benefits can be achieved by treating older patients with CHD more aggressively to reduce low-density lipoprotein cholesterol levels to less than 2.6 mmol/L (<100 mg/dL). The findings support the use of intensive low-density lipoprotein cholesterol-lowering therapy in high-risk older persons with established cardiovascular disease.


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A Multicenter, Randomized, Controlled Trial of Dexamethasone for Bronchiolitis

2007-08-01

Bronchiolitis, the most common infection of the lower respiratory tract in infants, is a leading cause of hospitalization in childhood. Corticosteroids are commonly used to treat bronchiolitis, but evidence of their effectiveness is limited.


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