MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'fda approval'. Sat, 03 Sep 2011 02:11:07 +0100 http://www.medworm.com/index.php?rid=5182033&cid=t_132596_117_f&fid=37824&url=http%3A%2F%2Fwww.doctorkalitenko.com%2Fblog%2Fdrug-approvals-halt%2F What does it mean when the FDA only approves 21 drugs in one year? Does it mean that the drugs being put before them are so terrible that they refuse to approve them? Maybe it means that they are so riddled with side effects that the FDA can’t possibly say yes. No!     It means that they have hit a wall. Resources have been tapped and there’s nothing new and world-altering that the market really needs. Aside from looking for cures, the drug needs have been exhausted. So, what’s next? Because the truth is that though medication may be exhausted, we are still suffering from the same problems. And if the pharmaceutical companies aren’t going to start moving to finding miracle cures, there has to be another way to make us feel better. The answer is functional medicine. What ... Doctor Kalitenko antiaging blog blogs http://www.medworm.com/rss/comments.php?id=5182033 Tue, 30 Aug 2011 16:46:32 +0100 5182033 http://www.medworm.com/index.php?rid=5174611&cid=t_132596_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fcancer-drug-demonstrates-no-survival-benefit-receives-fda-approval%2F2011.08.29 Recently, the FDA announced its approval, upon accelerated review, of a new drug, Adcetris (brentuximab) for patients with Hodgkin’s lymphoma that has relapsed after bone marrow transplant and for some patients with T-cell anaplastic large cell lymphoma (ALCL). This interests me for a lot of reasons, among them that I used to work in the field of lymphoma immunology and spent some time in my life studying molecules like CD30, the protein to which the new antibody binds. First, a mini-primer on the disease and numbers of patients involved: (more…) *This blog post was originally published at Medical Lessons* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=5174611 Mon, 29 Aug 2011 21:00:19 +0100 5174611 http://www.medworm.com/index.php?rid=5174618&cid=t_132596_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fplastic-surgeon-discusses-safety-and-effectiveness-of-new-anti-wrinkle-product%2F2011.08.28 The FDA has granted a license to the maker of laViv which is said to improve the appearance of smile lines without freezing the muscles of your face. Have you heard of this new drug? Does it work like it claims? Are there any side effects that are worrisome? Source: dailymail.co.uk/femail/article-2028456/New-biological-wrinkle-cure-touted-alternative-Botox-frozen-face.html Maybe. As we have discussed before, FDA approval is not a stamp of approval that a drug is effective. It just means that as far as current studies show, it is not harmful. Some drugs are FDA approved for years until later the FDA reconsiders and removes them from the market. Look at the relatively recent removal of Darvocet from the market after many years of FDA approval. LaViv is an interesting concept. (more…) ... Better Health blogs http://www.medworm.com/rss/comments.php?id=5174618 Sun, 28 Aug 2011 16:35:43 +0100 5174618 http://www.medworm.com/index.php?rid=5130752&cid=t_132596_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fwhy-this-diabetic-isnt-concerned-about-her-insulin-pump-being-hacked%2F2011.08.14 Jay Radcliffe is a fellow type 1 diabetic, and I remember reading his diabetes blog way back in the day, when I first started blogging.  We read and commented on each other’s posts, and we were both part of the blogosphere when the DOC first started to grow.  I knew he was married, had children, and did the day-to-day diabetes stuff that I did. Which is why when I read the mainstream media’s take on his pump-hacking research (this article, Insulin Pumps Vulnerable to Hacking, for example), I reached out to him immediately.  “Can I just tell you that my mother sent me this article about your research?  Do you have time to talk?” Jay was out in Las Vegas this morning, attending the Black Hat security conference, but he and I had a chance to hash it out over the ph... Better Health blogs http://www.medworm.com/rss/comments.php?id=5130752 Sun, 14 Aug 2011 14:00:57 +0100 5130752 http://www.medworm.com/index.php?rid=5096204&cid=t_132596_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fthe-perspective-of-the-clinical-trial-that-you-need-to-know%2F2011.08.04 There are big companies like Quintiles that run clinical trials around the world. There are local clinics that specialize in clinical trials and make a lot of money at it. There are, of course, pharmaceutical companies and device manufacturers who depend upon the results to gain marketing approval for new products. People in all those groups know a lot about trials. But the perspective that counts is the view from you and me – patients. Most of us do not enroll in clinical trials. We don’t want to get too up close and personal with anything “experimental.” And often our doctors never tell us about available trials anyway since it can be a lot of paperwork for them. Given that most people don’t enroll in trials and new science is delayed because of it and also because most people ... Better Health blogs http://www.medworm.com/rss/comments.php?id=5096204 Thu, 04 Aug 2011 18:00:38 +0100 5096204 http://www.medworm.com/index.php?rid=5050880&cid=t_132596_117_f&fid=37824&url=http%3A%2F%2Fwww.doctorkalitenko.com%2Fblog%2Ffda-decide-fate-cancer-drug-holds-life-hands%2F Back and forth goes the FDA when it comes to a decision regarding Avastin, the breast cancer treatment drug. The drug itself has an interesting history and relationship with the FDA. Back in 2004, Avastin received approval by the FDA. In 2007, the FDA suddenly pulled the approval, by a 5-4 vote. But only several months later re-granted the drug accelerated approval. Over the next couple of years it became a staple for women fighting breast cancer. Until last month, when the FDA announced it was questioning some of the studies done by the company and pulled approval once again. But what about the women who have been on it all these years? The debate is heated and not anywhere close to over yet. A study says it adds five months to your life, but now evidence says it actually marginally help... Doctor Kalitenko antiaging blog blogs http://www.medworm.com/rss/comments.php?id=5050880 Tue, 19 Jul 2011 17:27:55 +0100 5050880 http://www.medworm.com/index.php?rid=4984560&cid=t_132596_117_f&fid=37824&url=http%3A%2F%2Fwww.doctorkalitenko.com%2Fblog%2Flupus-drug-approved-cost%2F It was just recently announced that Benlysta, a lupus drug, was approved by the FDA, making it the first lupus drug approved by the group in 50 years. But out of this approval, we noted something shocking. A statement issued by the FDA. “In approving the drug, the agency said the findings suggested but didn’t definitively show that some patients had a reduced likelihood of severe flare-ups, a painful characteristic of the disease.” as per the Washington Post. (1)(2)(3) What this means is that this drug is not really effective.  Otherwise why would FDA say that it did not definitely show benefits? As a matter of fact the FDA held up the approval for some time because it wasn’t clear about the benefits of the drug. The next question is: if it is not clear about benefits, th... Doctor Kalitenko antiaging blog blogs http://www.medworm.com/rss/comments.php?id=4984560 Wed, 29 Jun 2011 17:15:35 +0100 4984560 http://www.medworm.com/index.php?rid=4610887&cid=t_132596_117_f&fid=37824&url=http%3A%2F%2Fwww.doctorkalitenko.com%2Fblog%2Finept-trials-tainted-studies-living-disease-waiting-cure%2F According to statistics, 1500 people die every day in the United States from cancer. Shocking statistic? Sure. But how long have these people lived with the disease, how long did they know about it? What kind of treatment did they receive? What kind of treatment could they have received if it was not held up in one study after another? A recent article in the Wall Street Journal highlighted perhaps the most amazing point (1) How long will someone have to wait for a drug to be approved? How many treatments are there that are being held up by inefficient trials while you or a loved one are dying of cancer. Here’s where a holistic doctor like myself just doesn’t understand. Why should we trust clinical studies? Well, there are years and years of various testing done before a product is ap... Doctor Kalitenko antiaging blog blogs http://www.medworm.com/rss/comments.php?id=4610887 Fri, 18 Mar 2011 22:38:31 +0100 4610887 http://www.medworm.com/index.php?rid=3533799&cid=t_132596_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2F177144%2F Happy birthday in advance to the pill! (It turns 50 this weekend.) Not only did the birth control pill revolutionize women’s sexuality, but it also meant major changes for F.D.A.’s regulation practices, according to today’s New York Times. Post from: BlissTree (Source: Breastfeeding 1-2-3) Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3533799 Wed, 05 May 2010 03:21:26 +0100 3533799 http://www.medworm.com/index.php?rid=3502831&cid=t_132596_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2010%2F04%2F25%2Fultrawellness-or-ultra-hype-antidepressant-as-demagogue%2F Mark Hyman, MD, is a “practicing physician and pioneer in functional medicine,” according to his bio on the Huffington Post where he recently penned the nonsensical, “Why Antidepressants Don’t Work for Treating Depression.” I say “nonsensical” because this article is based upon a study that came out 3 years ago, so writing this article to educate the public seems not to be its primary purpose. Exhibiting sound reasoning and logic also doesn’t seem apparent in this article, since generally a scientist or doctor would not dismiss an entire class of medications — antidepressants — based upon a single study. Or when there are many different types of antidepressants and sub-classes — SSRIs, tricyclics, MAOIs, SRNIs, etc. The stud... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=3502831 Sun, 25 Apr 2010 15:45:16 +0100 3502831 http://www.medworm.com/index.php?rid=3424820&cid=t_132596_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2Fshould-we-be-drugging-our-kids%2F When seven-year-old foster child Gabriel Myers hanged himself by a shower cord last year, all eyes turned to psychiatrist Dr. Sohail Punjwani, who had been treating the boy. The doctor had prescribed several powerful mental health drugs to Myers – some of which aren’t approved for use by kids, and had been linked to suicide among children. Image: istockphoto Every day, more and more youngsters around the country are being diagnosed with ADHD, depression, anxiety, autism, and other emotional disorders. Some parents and doctors jump to the conclusion that every hyper kid has ADHD, or that every sad child suffers from depression and needs medication. Somewhat surprising is the fact that the FDA has officially approved only one antidepressant drug for the treatment of depression in chi... Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3424820 Tue, 30 Mar 2010 21:30:31 +0100 3424820 http://www.medworm.com/index.php?rid=3322441&cid=t_132596_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FXA8UpFST0cs%2F Prescribing medications can be tricky for some physicians, depending on what their patient  has, how they want to treat it, and what is available for prescription. And, it’s particularly difficult if the condition they are trying to treat is either not responding to the traditional treatments or there really isn’t anything yet that has been developed for it. This is where off-label prescribing comes in. The FDA When the FDA approves a medication, it approves it for one or more specific conditions. It okays the dosage ranges, the frequency it can or should be taken, how long it can or should be taken and who should or shouldn’t take it. They base their decision on multiple trials and studies, where they should be given accurate information on how patients responded to wh... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=3322441 Mon, 01 Mar 2010 21:38:12 +0100 3322441 http://www.medworm.com/index.php?rid=2834387&cid=t_132596_131_f&fid=34989&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FGeneticsHealth%2F%7E3%2Fi_yQInvwMsY%2F This latest FDA approval would bring relief to more than 7.5 million Americans who suffer from a chronic skin disorder called PSORIASIS, which look like red, thick, scaly patches on the skin. Psoriatic patches, which are usually itchy and painful, are inflamed areas where excessive layers of cells had built up on the skin. And now, after extensive and extended testing, the FDA has approved ustekinumab (Stelara) for moderate to severe plaque psoriasis. (See amazing before-and-after photos!) Psoriasis is an auto-immune disease, which means a faulty immune system mistakenly attacks the skin and joints, treating the body like an invader and releasing chemicals that otherwise fight infections and foreign substances. As bad as it already looks, psoriasis affects more than the skin. The dis... Genetics and Health blogs http://www.medworm.com/rss/comments.php?id=2834387 Sat, 26 Sep 2009 03:56:00 +0100 2834387 http://www.medworm.com/index.php?rid=2447732&cid=t_132596_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FhJrmYWlhs2Q%2F Lamictal XR (lamotrigine) Extended Release Tablets have been approved by the US FDA for prescription to people, aged 13 or older, who have partial onset seizures. The original version of Lamictal has been available since the mid-1990s. Instead of trying to explain how it works, here is a video of a pharmacist explaining what Lamictal is. Just click on the TV screen: The newly approved extended version, Lamictal XR, limits the number of pills a person must take in a day - some people take several. The fewer medications a person has to take, the lower the chance of mistakes and the higher the chance of the person taking all medications as they should be taken. ~~~~ Image: iStock Share and Enjoy: Post from: Blisstree FDA Approves Extended Epilepsy Medication (Sourc... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=2447732 Mon, 01 Jun 2009 14:49:23 +0100 2447732 http://www.medworm.com/index.php?rid=2389931&cid=t_132596_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F05%2F06%2Fthe-problem-with-phase-iii-clinical-trials%2F Phase III clinical trials are the final phase of research needed before a drug receives U.S. Food and Drug Administration (FDA) approval. Two fairly large-scale studies are needed and they need to show the drug is both safe and effective on the subjects tested. There’s been a long-standing problem with such clinical studies, however, one that the FDA has long been aware of but powerless to fix. They are purposely designed to employ stringent inclusion and exclusion criteria that may exclude a substantial portion of the population. In other words, the people the drugs are studied on are not representative of the people that will actually be receiving the drugs once approved. In other words, Phase III clinical studies are stacked in favor of finding positive results for the medicatio... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2389931 Wed, 06 May 2009 09:06:31 +0100 2389931 http://www.medworm.com/index.php?rid=2348546&cid=t_132596_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F04%2F15%2Fwith-fda-change-ect-may-go-the-way-of-the-dinosaur%2F Last week, the U.S. Food and Drug Administration (FDA) finally decided to start taking action to close a loophole that’s been around nearly as long as the agency itself. Last Wednesday it said that it would require safety and efficacy data from manufacturers of medical devices in 25 different categories. This data is equivalent to the types of data the FDA currently requires for medical devices and drugs — data that shows the device is both safe and effective in use for a prescribed disorder. One of those 25 categories is electroconvulsive therapy (ECT) machines. Yes, you heard right. For decades, the most notorious of all psychiatric treatments available has never met any type of rigorous FDA approval for their use. How can this be? In the case of electroconvulsive therapy ma... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2348546 Wed, 15 Apr 2009 22:51:52 +0100 2348546 http://www.medworm.com/index.php?rid=1692384&cid=t_132596_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F359504449%2F Americans are likely to be exposed to unacceptable side effects of FDA-approved drugs because of flaws in the way new drugs are tested and marketed, according to research presented earlier this week at the annual meeting of the American Sociological Association. “Drug disasters are literally built into the current system of drug testing and approvals in the United States,” says Donald Light, a sociologist and a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey, who gave the talk. “Recent changes in the system have only increased the proportion of new drugs with serious risks.” Systematic reviews indicate that one in seven new drugs is superior to existing drugs, but two in every seven new drugs result in side effects se... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1692384 Fri, 08 Aug 2008 15:19:48 +0100 1692384 http://www.medworm.com/index.php?rid=1564171&cid=t_132596_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F325191337%2F An FDA advisory committee voted 14 to 2 that all new diabetes drugs should undergo longer studies to ensure cardiovascular risks aren’t increased, a move that is expected to cost drugmakers untold millions of dollars to conduct additional clinical trials, the Associated Press reports. The recommendation comes less than a year after the FDA was criticized for its handling of heart risks connected with Glaxo’s widely used Avandia diabetes pill, which was approved in 1999. The agency, however, didn’t add a warning about potential heart risks until last November, the AP notes. The majority of the panel said drugmakers could begin safety testing, which is expected to take between five and seven years to complete, before they submit drugs to the FDA and finish the studies after... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1564171 Wed, 02 Jul 2008 21:03:14 +0100 1564171 http://www.medworm.com/index.php?rid=1166421&cid=t_132596_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F220473495%2Fetravine_gets_fda_approval_for.html Tibotec Pharmaceuticals, a division of Ortho Biotech Products, announced that its drug Etravine has received U.S. Food and Drug Administration approval for the treatment of HIV infection in patients who have not responded to other antiretroviral treatments.The tablets sold under the name Intelence consist of a non-nucleoside reverse transcriptase inhibitor (NNRTI) that helps to block an enzyme that the HIV virus requires to multiply. The FDA approved it for use in combination with other HIV medications.Etravine was given a priority review, status given to medications that treat life threatening conditions. The FDA stated that the drug can reduce the amount of HIV in the blood and increase white blood cells that are needed to fight off other infections."This is another s... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1166421 Mon, 21 Jan 2008 15:00:53 +0100 1166421 http://www.medworm.com/index.php?rid=1108699&cid=t_132596_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F203612407%2Ftentative_fda_approval_for_gen_1.html The U.S Food and Drug Administration has announced that it has issued tentative approval for a generic version of Viread (tenofovir disoproxil fumarate). Viread is a drug that is used in combination with other antriretroviral agents in the treamtent of HIV."Tentative approval" means that the product meets all FDA manufacturing standards and safety and efficacy requirements but that existing patents or marketing exclusivity prevents final approval in the U.S at this time.“The fight to save lives with high-quality anti-retroviral treatment is of significant importance to FDA,” said Gary Buehler, director of FDA’s Office of Generic Drugs. “Our scientists have been working diligently to make safe and effective treatments for AIDS available as quickly as possib... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1108699 Thu, 20 Dec 2007 19:00:53 +0100 1108699 http://www.medworm.com/index.php?rid=1062889&cid=t_132596_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F193074550%2Fcymbalta_gets_fda_approval_as.html The U.S. Food and Drug Administration has approved Cymbalta (duloxetine HCl) for the maintenance treatment of major depressive disorder (MDD) in adults according to the drug manufacturer, Eli Lilly and Company (NYSE:LLY).The efficacy and safety of Cymbalta, as a maintenance treatment, was established in a double-blind, placebo-controlled clinical trial involving 533 patients with major depression. After 12 weeks, 278 patients met the criteria to continue in the trial and were randomly assigned Cymbalta or a placebo for the next six months. Those taking Cymbalta had a statistically longer period of time between relapses."Relapse, the re-emergence of depressive symptoms after a successful treatment of depression, is a significant clinical concern," says Doug Williamson, M.D., ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1062889 Fri, 30 Nov 2007 16:00:59 +0100 1062889 http://www.medworm.com/index.php?rid=1035616&cid=t_132596_122_f&fid=35055&url=http%3A%2F%2Fsarasotaneurology.com%2F2007%2F11%2F19%2Fseizures-medication-treatment-offers-hope-for-a-normal-lifestyle%2F Seizures are the manifestation of uncontrolled electrical activity in the brain. Affected individuals show clinical symptoms of seizures with twitching or jerking of one side or their entire body. With this they can make gasping noises, turn blue in the face, bite their tongue or lose control of their bladder. These symptoms are charateristic of a grand mal seizure. During an epileptic attacks, the person is not responsive or aware of what is going on around them. Fortunately there is excellent treatment available to control seizures and in many cases, keep patients seizure free. It is estimated that there are 2-3 million individuals in the United States who suffer from recurrent seizures (epilepsy.) Many of these people are neurologically intact with the cause of their seizures being unkn... Sarasota Neurology blogs http://www.medworm.com/rss/comments.php?id=1035616 Mon, 19 Nov 2007 11:32:22 +0100 1035616 http://www.medworm.com/index.php?rid=1003705&cid=t_132596_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F180045114%2F As Bob prepares to leave the ceo job on Jan. 1 and become chairman for an unspecified period of time, he’s using his final weeks to sound off quite sharply about the FDA, which has caused Wyeth unending aggravation this year by refusing to approve some of its drugs. In an interview with The Financial Times, Bob say the FDA “is establishing monopolies” by denying drug approvals. He’s concerned that FDA assessments now include whether a drug can work better than an existing product, instead of allowing the market to determine what it wants. Specifically, he says the FDA was blocking new drugs after their efficacy was compared to those already on the market. This is, he claims, beyond the FDA’s mandate and could prompt legal action. Whether he is about to sue isn... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1003705 Mon, 05 Nov 2007 13:42:24 +0100 1003705 http://www.medworm.com/index.php?rid=970104&cid=t_132596_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F173458404%2Ffda_expands_age_range_for_mena.html The bacterial meningitis vaccine, Menactra has been now been approved for use on people between the ages of 2 and 10 years. The FDA has previously approved Menactra, in 2005, for people between the ages of 11 and 55. Meningitis is an inflammation of the lining that surrounds the spinal cord and brain and can result in death or permanent injury to the brain and nervous system. An estimated 2,600 people in the U.S. contract meningitis annually and about 10% die.“Approving Menactra for younger children offers another option for health care providers and parents. Now there are two vaccines available for children between 2 and 10 years of age who may be at increased risk of meningitis,” said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation a... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=970104 Mon, 22 Oct 2007 21:30:38 +0100 970104 http://www.medworm.com/index.php?rid=968377&cid=t_132596_122_f&fid=35055&url=http%3A%2F%2Fsarasotaneurology.com%2F2007%2F10%2F22%2Fstroke-prevention-a-better-way-of-stroke-treatment%2F The objective is to have a total cholesterol less than 180, good cholesterol (HDL) of greater than 50 and bad cholesterol (LDL) less than 100. A recent study published in the journal Stroke reported that discontinuing statin therapy in the year after a stroke is associated with a significant increase in the risk for death, even in the absence of heart disease. Medications are not the only treatment for stroke prevention. Smoking is associated with a 2-3 times greater risk of stroke and bleeding in the brain. Smoking also contributes to the accelerated development of heart disease, emphysema and peripheral artery disease. Chantix is a new medication that received FDA approval to help stop smoking. Exercise is important in maintaining overall body conditioning and weight control. This in tur... Sarasota Neurology blogs http://www.medworm.com/rss/comments.php?id=968377 Mon, 22 Oct 2007 11:15:34 +0100 968377 http://www.medworm.com/index.php?rid=938781&cid=t_132596_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F167504668%2Fteva_pharmaceutical_industries.html Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that it has received final FDA approval for its Abbreviated New Drug Application for the generic version of Actonel.Actonel, a Procter & Gamble Company (NYSE:PG) product, is used in the treatment and prevention of postmenopausal and glucocorticoid-induced osteoporosis and for the treatment of Paget's disease.Teva is currently in patent litigation concerning the generic version of Actonel. A trial was held in November 2006 but no decision has been rendered. As part of the litigation Teva agreed to give a 30 day notice to Procter and Gamble prior to any launch of the product. Notice has not yet been given.Teva has been awarded 180 days marketing exclusivity for being the first company to file an Abbreviated New Dr... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=938781 Tue, 09 Oct 2007 17:00:03 +0100 938781 http://www.medworm.com/index.php?rid=931166&cid=t_132596_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F165859967%2Faptivus_tipranavir_gets_full_fda_approval.html Boehringer Ingelheim Pharmaceuticals Inc. announced that it has received full approval from the FDA for Aptivus. It had already received accelerated approval in June of 2005. Full approval was granted on data from a 48-week analysis of the Phase 3 clinic studies."Data show that APTIVUS/r may provide treatment-experienced HIV patients with an effective treatment option through nearly one year of therapy. Furthermore, longer-term safety data are now available for physician and patient consideration," said Dr. Daniel Kuritzkes, associate professor of medicine, Harvard Medical School; director of AIDS research, Brigham and Women's Hospital, Boston, MA.Aptivus has already been approved in Argentina, Australia, Canada, Switzerland, Mexico, Iceland, Taiwan and the European Unio... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=931166 Fri, 05 Oct 2007 21:00:17 +0100 931166 http://www.medworm.com/index.php?rid=928093&cid=t_132596_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F165270801%2F The agency notes that generics are cheaper as it announces GIVE - the Generic Initiative for Value and Efficiency - as a way to move the approval process along. Although the FDA approved or tentatively approved 682 generics in fiscal year 2007, or 30 percent more than the previous year, FDA commish Andy von Eschenbach wants to pick up the pace. And he’s going to hire more people to get it done. (Read more here). Faced with a backlog of 1,300 applications, up from about 800 about a year ago, the FDA is revising the review order for certain drug applications. For example, the agency says first generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review. This will mean th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=928093 Thu, 04 Oct 2007 15:57:32 +0100 928093 http://www.medworm.com/index.php?rid=886292&cid=t_132596_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F159005866%2Ffda_approves_flumist_for_child_1.html MedImmune Inc. announced that the FDA has now approved FluMist™ for use in children as young as 24 months. The expansion in age now allows for FluMist™ to be used on people from ages 2 - 59. FluMIst(TM) is an Intranasal Influenza Virus Vaccine that is approved for immunization against influenza A and B. A study of over 4,000 children between the ages of two and five saw a 54% decrease in cases of the flu in children who received FluMIst™ as opposed to those that received a traditional flu shot. FluMist differs from the traditional flu shot in that it consists of live, weakened viruses that help stimulate an immune response to influenza. Pedro Piedra, M.D., professor, Department of Molecular Virology and Microbiology, and Pediatrics, Baylor College of Medicine said &q... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=886292 Thu, 20 Sep 2007 13:56:37 +0100 886292 http://www.medworm.com/index.php?rid=885396&cid=t_132596_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F158640946%2Ftraumacure_inc_woundstat_1.html TraumaCure Inc. received news that the FDA has cleared its product, WoundStat™, after only six weeks of review.WoundStat™, a lightweight, pre-mixed dressing compound, has been scientifically proven to control high pressure bleeding in moderate to severe wounds.  "The FDA's speedy approval of WoundStat means that we can get it more quickly into the hands of those who need it most today -- our war fighters in harm's way around the world." said Devinder S. Bawa, chief executive officer of TraumaCure, the developer of WoundStat. "The products effectiveness is particularly important with core body wounds that a tourniquet can't reach. We believe that WoundStat has the potential to provide the military with another important tool to minimize ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=885396 Wed, 19 Sep 2007 18:24:26 +0100 885396 http://www.medworm.com/index.php?rid=856806&cid=t_132596_122_f&fid=35055&url=http%3A%2F%2Fsarasotaneurology.com%2F2007%2F09%2F10%2Ffibromyalgia-new-therapy-offers-hope%2F Fibromyalgia is a chronic muscle pain disorder that has no underlying identifiable cause. Sufferers have muscle pain, multiple areas of tenderness and fatigue. It is a poorly understood disorder, with many physicians not even acknowledging that it is a real illness. There is , however ample evidence that fibromyalgia is a real condition as it has been estimated that as many as 6 million Americans suffer from this affliction annually. Patients typically see several physicians and become frustrated when all their testing comes back normal. Other accompanying symptoms may include poor sleep hygiene, headache, mental clouding (fibromyalgia fog) and depression. Although this conditions rarely clears, suffers can be treated successfully with a combination of medications and regular exercise. The... Sarasota Neurology blogs http://www.medworm.com/rss/comments.php?id=856806 Mon, 10 Sep 2007 12:06:26 +0100 856806 http://www.medworm.com/index.php?rid=830972&cid=t_132596_122_f&fid=35055&url=http%3A%2F%2Fsarasotaneurology.com%2F2007%2F08%2F30%2Fshingles-vaccine-postherpetic-neuralgia%2F Shingles is a condition characterized by a painful, blistering skin rash. This rash can affect any part of the body. The medical name for shingles is Herpes Zoster. It is the caused by the same virus that causes chicken pox. People who have had chicken pox are potentially at risk for developing shingles later in their life. Patients who have never had chicken pox can get this from individuals who have an active attack of shingles, as the rash is contagious. Shingles can appear anywhere on the body but tend to follow the distribution of the nerves, as this is where the virus lives. Although severe in any part of the body, facial involvement around the eye presents an even greater problem. If shingles involves the upper face, the eye can be affected, potentially leading to eye complications ... Sarasota Neurology blogs http://www.medworm.com/rss/comments.php?id=830972 Thu, 30 Aug 2007 11:06:48 +0100 830972 http://www.medworm.com/index.php?rid=776180&cid=t_132596_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2007%2F08%2Fwalk-on-warriors-alone-or-together.html I left this comment at Writhe Safely, and it was removed. I dared to entertain the ideal. The one where we all come together as one voice. Maybe I was a sucker. Like in the lunchroom cafeteria, sitting alone and having a group beckon me for company. Only to be made fun of and used as an example of the opposite of what they believe in.I believe in them, whether deleted or removed, they won't believe this, but I am who they are. I am a voice, and I have learned how to be one that is listened to in the world I too---hate.But to be heard, sometimes we have to be quiet and listen. I never would have been able to get my daughter out of a state institution without keeping my mouth shut when I needed to and speak when I knew I was to be heard.I am a mother, yes I am. I am not sorry for that.I am a... soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=776180 Fri, 03 Aug 2007 05:09:00 +0100 776180 http://www.medworm.com/index.php?rid=692644&cid=t_132596_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2007%2F06%2Fautism-and-psychosis-mood-disorders-are.html Autism and Familial Major Mood Disorder: Are They Related?Comparison of Clinical Features of Autism and Major Mood Disorder"And it may not be amiss to think of autism, in some cases, as a chronic psychosis."~Mood Disorder in Idiopathic Autism"Even the regression that commonly heralds the onset of autism may be interpreted as the onset of depression, characterized not only by loss of language, but by social withdrawal, loss of eye contact, moodiness, tantrums, fearfulness, and occasionally self-injurious behavior. Later, in some children, the full expression of manic depression may become evident and is marked by extreme cyclicity of moods, oppositional/defiant behavior, hyperexcitement (e.g., hyperactivity, aggressiveness, rage), and vegetative signs of mania (e.g., decreased sleep, excess... soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=692644 Sat, 23 Jun 2007 23:00:00 +0100 692644 http://www.medworm.com/index.php?rid=660539&cid=t_132596_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2007%2F06%2Frunning-for-freedom.html This is yet another intense blog post from Schizophrenia- A Carer's Journal.I read this blog every day, anxiously waiting to see how Sam is doing. I struggle alongside the author and Sam's father; thinking the same thoughts after experiencing some similar situations. I admire Mike's honest writing, and can relate to so many stories about wondering where his son ran to, walked to or disappeared. Sam has a great support in his family and others around him. This entry says much of my struggle.Though Sam and Lindsay are different people--I've heard Lindsay say what Sam did to his psychologist,""I don't know you," said Sam and started to run."Reading Mike lamenting about hospitals and freedom to walk and run free--I want Mike to know that I understand that struggle, and see the freedom to be on... soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=660539 Wed, 06 Jun 2007 11:37:00 +0100 660539 http://www.medworm.com/index.php?rid=645389&cid=t_132596_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2007%2F05%2Fill-stand-by-you.html The road was once again drenched in a heavenly light, breaking through the rain clouds, the sun always shined on the way toward Western State Hospital.I was a few miles away, and my hands gripped the steering wheel hard. My stomach was a lost cause at that point, I just was unable to eat or deal with that pain. I often arrived with puzzles, books, candy, soda, whatever I could. The rock wall was what got me every single time. I just could not believe that lined the road and was created by former patients. I always wondered who they were. I was shocked when a co-worker told me a relative died there, and she told me she always wanted to go see her relative there, but her father would not allow her to go. This woman was brought to tears when she told me this story as I made copies of a book a... soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=645389 Wed, 30 May 2007 00:53:00 +0100 645389 http://www.medworm.com/index.php?rid=631699&cid=t_132596_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2007%2F05%2Funplugged-profiling-hospital-number-one.html from my personal notes:Tue Nov 2, 2004 7:32 pmHotdog night "August 17, 1999 I drove Lindsay with the entire family, including mymother to [private] Psychiatric hospital in [city], washington."Just relax" the dentist said to me, "I am sorry to hear about yourdaughter, I have been there, my mom was in [that same hospital] when I was12.Imagine being 12 and having to be the kid whose mom was in[same hospital].""It's ok Lindsay, hey look these hotdogs arent so bad", I looked around, and there were other families trying to make it all sound normal, some were there without families, Lindsay was the one withthe most relatives there, and her 5th grade camp teacher Mrs,[name]came to see her.Her eyes rolled up and she shook so bad, she was white as a ghost,and we laid towels on her head,We taped pict... soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=631699 Wed, 23 May 2007 02:29:00 +0100 631699 http://www.medworm.com/index.php?rid=620661&cid=t_132596_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2007%2F05%2Fsubliminal-subdivision-of-bipolar.html Subthreshold bipolar disorder.I think we are standing on the threshold of hell. Or, quite possibly all able to jump on the bipolar disorder diagnosis train, and quite possibly have a claim to fame, after all, anything we do from now on, whether it's creative writing, painting, sewing, just being eccentric in floral bathrobes walking to the mailbox could be written off as SBD.We can all be added to the famous people list of "who has bipolar and became famous and functional".Personally, I will be known as that about town community activist who snuffed out burn piles and got on the news for it--"Hey she was SBD?" we knew it! I can hear it now. "That lady who got the C-Curb placed on a dangerous road was SBD?" I knew it! "That mother who wrote the Governor when her daughter was in danger of ra... soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=620661 Fri, 11 May 2007 22:43:00 +0100 620661 http://www.medworm.com/index.php?rid=598229&cid=t_132596_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2007%2F05%2Fthey-keep-asking-me-why.html Today was another traumatic day. For me. For Lindsay. Dentist office staff this time. Asked the big question. "Why?" What happened, why is she like this now?" They've known her since she had toddler teeth. They've seen her as she was before, and also are the ones who called me when she went into the hospital loop to cry and tell me they were so sorry, "We love Lindsay."I remember sitting down thinking how the dentist office staff called me and told me they loved my kid. They called all throughout her hospitalization and they were so excited to see her for her last check up in September.Now they've seen it. The abyss. The inability to verbalize anything is wrong, and for the first time ever, I had to sit with her while she cried, and well I ended up having a crying breakdown when I made her... soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=598229 Mon, 07 May 2007 23:32:00 +0100 598229 http://www.medworm.com/index.php?rid=590562&cid=t_132596_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2007%2F05%2Fmedication-vs-discipline-vs-adhd-vs.html "Give him Ritalin""I tried that, he “came down” from that med each afternoon and cried uncontrollably for two hours. That was not my son. His behavior did not change. I stopped giving him the Ritalin. I lied about giving him the meds. “From now on,” I told him, “you are responsible for how you behave."The Bipolar Chicks Blogging have taken on the Childhood Bipolar Disorder Paradigm, with one personal story regarding medications and discipline, and what one person did, when medication wasn't the answer or choice for this mom.Bring on the Hate Mail-I’ve Spanked my 4 Year Old, Instead of Drugging Him.There's also a new read at Philip Dawdy's Furious Seasons with a link to CBS' "The Early Show" The Bipolar Children Are Killing My Back discussing Childhood Bipolar in kids. Which quo... soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=590562 Sat, 05 May 2007 03:39:00 +0100 590562 http://www.medworm.com/index.php?rid=555045&cid=t_132596_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2007%2F04%2Flegally-bombed.html Seroquel. Created for schizophrenia, and prescribed for insomnia, anxiety, depression, bipolar..you name it, it's the bomb. I took this stuff for 6 months. I couldn't wake up in the morning and my hands have felt detached from my arms until recently when I stopped the shit cold turkey. Then, I vomited, had the shakes, severe abdominal pain, and felt like I should be in re-hab. Looks like there's a market for this shit on the streets as well. Little pink pills. I was so out of it one night on this stuff, the photo is an example of my "art project" I created when I couldn't sleep due to nightmares from Seroquel.Bipolar Chicks blogging has a good post up today Seroquel Snorters: My New Best Friends about Seroquel abuse, and Furious Seasons had this one up back in January, So It's Called A "Q ... soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=555045 Fri, 20 Apr 2007 01:39:00 +0100 555045 http://www.medworm.com/index.php?rid=552126&cid=t_132596_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2007%2F04%2Fthinking-blogger-award-5-more-blogs-to.html Jon, author of the blog, Living With A Purple Dog was kind enough to add me to his 5 choices for Thinking Blogger Award. Thank you.I am continually inspired by bloggers and their stories. The more I read, the more I learn, and the blogosphere just keeps expanding my understanding of real people, out there somewhere, constantly amazing me with personal stories and life happenings. From mental health to disability, brain malformations and feminism--well I could spend hours reading and learning, and most of all really thinking quite a bit as a result. I am happy to be chosen again, not for myself--but so I can highlight a few more blogs I have come across the last month or so and share them here. Thanks for enriching my life with your stories everyone, I am honored to be a part of this world.... soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=552126 Wed, 18 Apr 2007 10:07:00 +0100 552126 http://www.medworm.com/index.php?rid=552139&cid=t_132596_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2007%2F04%2Fseroquel-withdrawal-update-part-12-no.html I have still not returned to using Seroquel. The most significant things that are now out of my life since removing Seroquel are no more nightmares. I am talking torture nightmares, the kind that keep you from sleeping. Insomnia was worse on the Seroquel, though it was prescribed for a mania run of insomnia. I sleep well, and if I am awake during the night, or awake early, it is because that's just how I always have been. I can wake up now without that train wreck fog, which I still think needs a better description. It slammed me down hard, and my hands always seemed detached from my body, it was hard to focus to see and drive the car in the morning, and I was lucky if I felt awake at all by noon. The weight loss leveled off, so that's a bummer.I am alert, I wake up without an alarm clock ... soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=552139 Sat, 14 Apr 2007 18:00:00 +0100 552139