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FDA: Boxed Warning On Serious Mental Health Events To Be Required For Chantix And Zyban
The U.S. Food and Drug Administration announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.
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Osiris Therapeutics Reports Interim Data For COPD Stem Cell Study
Therapeutics, Inc. (NASDAQ:OSIR) announced six-month interim data from a Phase II clinical trial evaluating Prochymal, the Company"s proprietary formulation of adult mesenchymal stem cells, for the treatment of chronic obstructive pulmonary disease (COPD). Sixty-two patients were enrolled and are being followed for two years in the placebo-controlled study. At the six-month time-point, the data revealed several important findings.
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New Tool To Improve Patient Understanding Of Long-Acting Injectable Antipsychotic Therapies
A new instrument for improving patient understanding and acceptance of long-acting injectable antipsychotic therapy (LAT) has been published in the April edition of Psychiatry 2009.1 This novel, psychosocial approach encompasses Goal setting, Action planning, Initiating treatment, and Nurturing motivation (GAIN) through the use of a clinical discussion tool.
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Lanreotide Confers Multiple Benefits In Acromegaly Patients

WASHINGTON D.C. - Most patients with acromegaly who are switched to the long-acting somatostatin analogue lanreotide (SomatulineR Depot) injection from initial treatment with octreotide cite a preference for lanreotide as their future therapy, according to data released here at the 91st Annual Meeting of the Endocrine Society (ENDO 09). The results, from the multicenter Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel (SALSA) study, also demonstrate good efficacy and tolerability with self- or partner-inject lanreotide. "The main message to clinicians is that patients with acromegaly can either inject themselves with the medication or have a family member rather than a health care professional do it for it for them, thereby avoiding monthly trips to the doctor"s office," said SALSA principal investigator Roberto Salvatori, MD, associate professor of medicine at Johns Hopkins University in Baltimore. Dr. Salvatori and co-workers tested the convenience, safety, and efficacy of self- or partner-administration of lanreotide in 59 acromegalic patients who were switched directly from lanreotide and in other patients who were treatment-naç¯ve or not currently on lanreotide. The study"s primary endpoint was the percentage of patients/partners competent to self- or partner-administer lanreotide at study completion as assessed by the health care professional. . Overall, 41 patients said they were able to correctly self-inject, and the other 18 were able to correctly partner- inject lanreotide. Self- or partner -administration of lanreotide was associated with insulin growth factor (IGF)-1 and growth hormone (GH ) control in many patients with acromegaly (73.1% of switch and 30.4% of other patients) at the end of the trial. Self- or partner-administration of lanreotide was generally well tolerated, and fewer lanreotide-treated patients described their injections as painful. Eight one percent of patients said they preferred lanreotide for future use, 13 percent favored octreotide, and six percent voiced no preference. Dr. Salvatori said that about 50 to 60% of patients with active acromegaly respond to the somatostatin analogue class of medications. The ideal patient, he added, is a patient who has either failed surgery (not cured) or for whom surgery would be risky (coexisting diseases) as well as the patient who is unlikely to be cured (tumors with extension in nonoperable areas but without compression of the vision pathways). Acromegaly results from an excessive production of growth hormone, which produces an enlargement and overgrowth of many organs, bones, and soft tissues as well as metabolic and biochemical changes. About three to four out of every million adults will develop the condition each year. The disorder is often misdiagnosed because of its wide range of symptoms and their slow onset, and it may take in some cases take up to ten years to establish a correct diagnosis. Unless treated, acromegaly can lead to severe sequelae, including the onset of type 2 diabetes, hypertension, arthritis, an increased risk of cardiovascular disease, and colon cancer. Written by Jill Stain Jill Stein is a Paris-based freelance medical writer. jillstein03(at)gmail.com Copyright: Medical News Today Not to be reproduced without permission of Medical News Today


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