The U.S. Food and Drug Administration (FDA) has approved four vaccines for use against the 2009 H1N1 influenza virus. The vaccines—made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc.—will be distributed nationally after the initial lots become available. This is expected to occur within the next four weeks.
So why is it that USA citizens in many states have the option to choose whether they or their children have the HPV vaccine but immigrants can not? In order to become a permanent, legal resident of the U.S, immigrants now must receive a vaccine that is not required of U.S. citizens. This is like saying these people are less important or more likely to be infected. This surely is wrong.
Earlier this week the Journal of the American Medical Association published an analysis of safety data that found the most common serious side effect was fainting, though some more severe adverse event occurred in Gardasil patients, including more than two dozen deaths. But the FDA and CDC say there’s no evidence the deaths or other severe effects were actually caused by the shot, and the agencies emphasize that they have reviewed the same safety data repeatedly.
State mandated Gardasil shots for preteen girls to protect them from the viruses that causes cervical cancer, are targeting the wrong age group. Middle-school girls inoculated with the HPV vaccine will be no older than eighteen when they pass Gardasil’s five-year window of proven effectiveness — more than a decade before the typical cancer patient contracts the sexually transmitted human papillomavirus (HPV). Merck & Co. has repeatedly refused to respond to requests for its HPV incubation statistics, stating that it is still studying the longevity of Gardasil.
No matter where you stand within the American, political color-spectrum, Reds and Blues all agree: Michelle Obama is a fiercely protective Momma. To my mind that is a very good thing. However as the Adverse Reactions to the HPV vaccine Garasil continue to mount, I find myself asking WWMOD? What Will Michelle Obama DO?
If the stockpiling entity decides to retain expired or soon-to-expire Tamiflu and Relenza, it should be maintained and monitored under the product’s labeled storage conditions. These organizations are also urged to contact the FDA’s Emergency Operations Center with information on how much Tamiflu and Relenza in their stockpiles is at or approaching expiration.
In response to increased public awareness of Influenza A virus H1N1 strain, the FDA has released a list of 2009 H1N1 Flu Virus and Antivirals Questions and Answers
rom approximately November 2001, through April 2005, HOLLOWAY was employed as a Regional Manager at a pharmaceutical company and was responsible for sales in her region of the drug Bextra. Bextra was a Cox-II inhibitor and had been approved in by the Food and Drug Administration (FDA) in November 2001 for the signs and symptoms of osteoarthritis, adult rheumatoid arthritis, at 10 mgs and primary dysmennorhea at 20 mgs, twice a day as needed. In 2001, the FDA specifically denied the request of the pharmaceutical company to approve it for acute pain, including the pain of surgery. The FDA told the pharmaceutical company that it could not approve it for these other indications because the safety in these other uses had not been established. Specifically, the FDA was concerned about the results of a study in which there was an excess of cardiovascular events in patients who had undergone coronary artery bypass graft surgery and used Bextra.
“We are committed to aggressively pursuing those who attempt to take advantage of a public health emergency by promoting and marketing unapproved, uncleared, or unauthorized products,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “We have achieved some success and will remain vigilant in our efforts to protect consumers from these fraudulent, potentially dangerous products.”
FDA notified healthcare professionals that it is providing its perspective on study data published in the American Journal of Psychiatry on the potential risks of stimulant medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children. This study, funded by the FDA and the National Institute of Mental Health (NIMH), compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident.The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children. Given the limitations of this study’s methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children.
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