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No Known Connection Between Childhood Abuse And Lupus
In recent news reports, there was a statement made that abuse experienced as a child can later lead to the development of autoimmune diseases, including lupus. There is no scientific evidence to support this statement, either in humans or animal models of lupus. Stress is sometimes listed as a "trigger" for a lupus flare in a patient that has lupus. Even this hypothesis is only supported by anecdotal data and not a well defined clinical study. There is clearly a connection between the immune system and the nervous system. Stress can induce a number of physiologic changes that can last for varying periods of time. To suggest, however, that child abuse is an accepted cause of lupus is inaccurate and unsupportable until there is clear data linking childhood abuse with later development of lupus.
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Sepracor's STEDESA™ (Eslicarbazepine Acetate) New Drug Application Formally Accepted For Review By The FDA
Sepracor Inc. (Nasdaq: SEPR) today announced that it has been notified by the U.S. Food and Drug Administration (FDA) that the New Drug Application (NDA) for STEDESA™ (eslicarbazepine acetate) has been accepted for filing and is now under formal review. As previously announced, the NDA for STEDESA was submitted to the FDA on March 31, 2009 for adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. The acceptance of the filing means that the FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review.
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Government Of Canada Acts To Protect Newborns And Infants From Bisphenol A In Polycarbonate Plastic Baby Bottles
The Government of Canada is moving forward with proposed regulations to prohibit the advertisement, sale and importation of polycarbonate plastic baby bottles that contain bisphenol A, otherwise known as BPA, to reduce newborn and infant exposure to this substance, announced the Honourable Leona Aglukkaq, Minister of Health.
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FDA Recommends Gardasil Recipients Sit, Lie Down After Receiving Vaccination

In a posting aimed at health care professionals, FDA on its Web site on Wednesday said that recipients of Merck"s human papillomavirus vaccine, Gardasil, should be closely observed afterward for 15 minutes while they remain seated or lying down to avoid the possibility of fainting, the Wall Street Journal reports. FDA said that since October 2007, Gardasil"s labeling for both health care providers and patients has included a discussion about fainting. The agency said the strengthened recommendation comes in response to reports of "traumatic injuries" among some recipients who experienced fainting (Corbett Dooren, Wall Street Journal, 6/10). Gardasil protects against the strains of HPV that cause most cases of cervical cancer and genital warts. The Centers for Disease Control and Prevention recommends that girls ages 11 and 12 receive the three-dose vaccine before they are sexually active. Girls and women ages 13 to 26 who have not been vaccinated or completed the vaccine series also should receive the vaccine (CDC fact sheet, June 2008). On Wednesday, FDA also approved changes to Gardasil materials that place warnings about fainting in a more prominent place on drug labels and handouts. The agency said that the new recommendations are intended to "prevent falls and injuries" (Wall Street Journal, 6/10). Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women"s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women"s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company. © 2009 The Advisory Board Company. All rights reserved.


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