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Category Archives: Drug Side Effects
Nektar Presents Positive Preclinical Data for NKTR-171, A Novel Sodium Channel Blocker to Treat Neuropathic Pain, at …
Posted: Published on October 15th, 2012
SAN FRANCISCO, Oct. 15, 2012 /PRNewswire/ --Nektar Therapeutics (NKTR) today announced that preclinical data for NKTR-171, a new investigational drug candidate to treat neuropathic pain, was presented at the 41st Annual Meeting of the Society for Neuroscience: Neuroscience 2012. NKTR-171 is a novel sodium channel blocker designed to act in the periphery in order to treat neuropathic pain while avoiding the serious central nervous system (CNS) side effects associated with current therapies, including anti-epileptic and anti-convulsant medications, such as gabapentinoids. Neuropathic pain, also known as nerve pain, is a type of chronic pain that occurs when nerves become injured or damaged by systemic disease, infections, autoimmune disease, or physical trauma due to toxins or injuries. It is estimated to effect more than 20 million people in the U.S. alone.1 "Sodium channels have long been known to play a significant role in the changes in neuronal excitability that lead to neuropathic pain," said Stephen Doberstein, Ph.D., Senior Vice President and Chief Scientific Officer of Nektar Therapeutics. "We are extremely pleased that NKTR-171 exhibits effective analgesia in multiple neuropathic pain models without generating the CNS side effects observed with current therapies used to treat neuropathic pain. We look forward to continuing to … Continue reading
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European Regulators Seeks Stronger Pradaxa Guidance for Bleeding Side Effects
Posted: Published on October 13th, 2012
Posted by Michael A. StrattonOctober 12, 2012 7:05 AM Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drugs label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA),the new guidance should include more specific information on when Pradaxa must not be used, as well as advice on managing patients and reversing the anticoagulant effect if Pradaxa bleeding occurs. Pradaxa was approved in Europe in March 2008 for the prevention of venous thromboembolic events following hip or knee replacement surgery. The blood thinner recently had its European approval expanded to cover patients with non-valvular atrial fibrillation to prevent stroke and systemic embolism. According to a report from Pharma Times, the number of fatal bleeding events among Pradaxa users spiked following that expansion. The EMAs Committee for Medicinal Products for Human Use (CHMP) had concluded an earlier review of Pradaxa in November 2011, after it had been linked to 250 patient deaths. At the time, CHMP asked that label information on bleeding risks be strengthened. The Committee also advised caution when using Pradaxa, and said it should be prescribed at lower doses to older patients and … Continue reading
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How social data could help expose drug side effects, personalize prescriptions
Posted: Published on October 13th, 2012
Social data pulled from online health forums and the comments section of blogs is helping patients learn about side effects to various drugs and could ultimately help them figure out the medications that suit them best. As a senior in high school, Julia Winn was diagnosed with clinical depression. For two years, she took medication, sought therapy and saw 10 different doctors, but no one could figure out a cause. Finally, after seeing a specialist, she learned that the culprit was her hormonal birth control pill, which has a well-documented relationship with depression. Using her medical history and experience with the first birth control pill, the specialist recommended a more appropriate alternative and, since then, Winn said shes been fine.But, having figured out the best medication for herself, the 23-year-old Harvard graduate is building a startup that leveragessocial data and natural language processing to help other women discover what could work better for them. The larger goal is to change the way doctors think about patients and change the way patients think about themselves, she told me at the Health 2.0 conference this week in San Francisco. Its not one size fits all. Part of TechStars Bostons fall class, MyBetterFit … Continue reading
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Work just beginning as drugmakers put Nobel discoveries to test
Posted: Published on October 11th, 2012
* Hundreds of receptors are targets for drug discovery * Goal is to make better drugs with fewer side effects * Potential to treat a vast array of diseases By Julie Steenhuysen and Ben Hirschler CHICAGO/LONDON, Oct (KOSDAQ: 039200.KQ - news) 10 (Reuters) - For some scientists, winning a Nobel Prize marks the end of a long and successful career. But the work, in a sense, is just beginning for newly minted Nobel laureates in chemistry Dr. Brian Kobilka, 57, of Stanford University in California, and his mentor, Dr. Robert Lefkowitz, 69, of Duke University Medical Center in Durham, North Carolina. "There is still a lot to do," Kobilka said in a telephone interview from his home in Palo Alto, California, where he learned of his prize early on Wednesday morning. "There is a lot to do." In research spanning four decades, the scientists working separately and together have helped to characterize the exact structure of an important class of proteins known as G-protein-coupled receptors or GPCRs, which serve as a main conduit for chemicals to get past a cell's membrane and be taken up by a cell. Roughly 1,000 human genes carry genetic codes for the receptors, which affect … Continue reading
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Health Canada warns against use of highest dose of anti-nausea IV drug Zofran
Posted: Published on October 11th, 2012
Health officials in Canada are warning about potentially life-threatening side effects associated with an anti-nausea drug. Zofran, a drug thats administered at 32 milligrams intravenously, should be avoided altogether, Health Canada is warning. The agency is warning that the drug administered at this dose can impact a patients QT interval, a measure of a hearts electrical activity. Zofran at this dose can prolong a patients QT interval. This condition can lead to dizziness and cause an irregular heartbeat. A report from Canada Broadcasting Corp. adds that QT interval can also cause fainting and death. QT prolongation could also result in a fatal condition known as Torsades de Pointes. Considering these dangerous side effects, Health Canada has mandated that no higher dose than 16 milligrams of Zofran be administered to patients. This drug, at 32 milligrams, is dispensed to patients who undergo chemotherapy in the treatment of cancer and to post-operative patients to prevent nausea and vomiting. In addition to its brand name form, Zofran is also known asondansetron hydrochloride dihydrate or ondansetron in generic form. Health Canadas warning does not include any dosing instruction changes for lower doses of Zofran, including those who are given the drug orally and for … Continue reading
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Americans Win Nobel for Figuring Out How the Human Body Talks to Cells
Posted: Published on October 11th, 2012
Dr. Robert J. Lefkowitz and Dr. Brian K. Kobilka are the reason drug makers can and will make drugs with fewer side effects, and after 40 years spent studying the body's protein receptors, they have won the 2012 Nobel Prize in Chemistry. Lefkowitz and Kobilka have been researching "G-protein-coupled receptors," which are the protein receptors and form of communication the body uses to tell cells what's going on. An example The New York Times's Kenneth Chang uses is what we know as "fight-or-flight." Lefkowitz and Kobilka figured out how G-protein-receptors figure into all of that."They serve as the gateway to the cells," Lefkowitz said in report by CNN's Ben Brumfieldthe receptors sense adrenaline, which sets off reactions and triggers within the cell. "Around half of all medications act through these receptors, among them beta blockers, antihistamines, and various kinds of psychiatric medications," explained the academy in Brumfield's report. Experts believe the research will only lead to better medicine. "In particular Kobilka's work in determining the structure of G-protein coupled receptors has revolutionised our understanding of how they work as small 'molecular machines' and will lead to enormous advances in drug design,"one expert told the BBC. Read more from the original … Continue reading
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Synthetic liver enzyme could result in more effective drugs with fewer side effects
Posted: Published on October 10th, 2012
ScienceDaily (Oct. 9, 2012) Medicines could be made to have fewer side effects and work in smaller doses with the help of a new technique that makes drug molecules more resistant to breakdown by the human liver. Researchers based at Princeton University reported in the journal Science that they created a synthetic enzyme that acts as a catalyst to replace certain hydrogen atoms of a drug molecule with fluorine atoms. This swap stabilizes the molecule and makes it resistant to the liver enzymes that can inactivate a drug or create toxic byproducts. "Putting fluorine in place of hydrogen in a molecule tends to result in higher potency and lower toxicity," said first author Wei Liu, a graduate student in the laboratory of John Groves, Princeton's Hugh Stott Taylor Chair of Chemistry. Wei worked with Groves and second author Xiongyi Huang, a Princeton chemistry graduate student, as well as with Professor William Goddard III, researcher and lab director Robert Nielsen, and graduate student Mu-Jeng Cheng, all of the California Institute of Technology's Materials and Process Simulation Center. Substituting fluorine for hydrogen changes the ability of liver enzymes to modify a drug, Groves said. Those enzymes break down medicines and other foreign … Continue reading
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Neutron Crystallography Aids Drug Design
Posted: Published on October 10th, 2012
Precisely tailored pharmaceuticals could reduce medical side effects LOS ALAMOS, N.M., Oct. 9, 2012 /PRNewswire-USNewswire/ --Researchers at Los Alamos National Laboratory have used neutron crystallography for the first time to determine the structure of a clinical drug in complex with its human target enzyme. Seeing the detailed structure of the bonded components provides insights into developing more effective drugs with fewer side effects for patients. (Photo: http://photos.prnewswire.com/prnh/20121009/DC89923 ) The atomic details of drug binding have been largely unknown due to the lack of key information on specific hydrogen atom positions and hydrogen bonding between the drug and its target enzyme. In this research, scientists used the drug acetazolamide (AZM) -- a sulfonamide drug that has been used for decades to treat a variety of diseases such as glaucoma, altitude sickness, and epilepsy. But when the drug binds with the wrong form (called an isoform) of the target enzyme for the disease, it can produce unpleasant side effects in patients (so called "off-target" drug binding). Enter neutron crystallography the use of neutron scattering to paint a picture of these bonds. By providing precise information on hydrogen bonding between target enzymes and the treatment drugs (carbon anhydrase II targeted by AZM in … Continue reading
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Fosamax Side Effects Make Drug a Poor Choice for Women with Osteopenia, According to Consumer Reports.
Posted: Published on October 10th, 2012
Fosamax femur fractures, along with the risk for other Fosamax side effects, leads to a Consumer Reports recommendation that the drug not be used by women with osteopenia, Bernstein Liebhard LLP reports. New York, New York (PRWEB) October 09, 2012 Consumer Reports is to be commended for its clear recommendation against the use of Fosamax for women with osteopenia, says Bernstein Liebhard LLP, a nationwide law firm that represents victims of defective drugs and medical devices. Given the mounting evidence linking Fosamax to femur fractures and other serious side effects, this is wise advice. Fosamax Side Effect Lawsuits Fosamax is an oral bisphosphonate used to prevent fractures in people who have bone weakening diseases like osteoporosis and Pagets disease. In October 2010, the U.S. Food & Drug Administration (FDA) warned that people taking Fosamax and other bisphosphonates for osteoporosis are at risk of suffering atypical femur fractures.** Just this past May, an FDA-commissioned analysis published in the New England Journal of Medicine found that there was little benefit in taking Fosamax and similar drugs for longer than five years. The report cited serious Fosamax side effects, including femur fractures and osteonecrosis of the jaw (ONJ, or dead jaw syndrome).*** Fosamax … Continue reading
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Study tests potential new drug to reduce pain and symptoms of endometriosis
Posted: Published on October 9th, 2012
ScienceDaily (Oct. 8, 2012) According to the Centers for Disease Control (CDC), endometriosis, a gynecological disorder in which cells from the uterus lining grow in other areas of the body, is the number one reason for a hysterectomy in women ages 18-35. Current treatment options for endometriosis are severely limited by side effects of existing medications and surgical options have more risks. A nationwide clinical trial is testing an investigational drug as a potential new option for patients with moderate to severe pain from this disease. The Violet Petal Study, funded by Abbott and led at UC San Diego by Sanjay Agarwal, MD, FACOG, with the Department of Reproductive Medicine at UC San Diego School of Medicine, is currently recruiting patients to be part of the one to two year study to investigate the safety and effectiveness of the oral drug Elagolix. "Endometriosis can be an extremely painful disease, especially during a woman's menstrual cycle. Many women find themselves debilitated during these bouts, and the disease can also cause pain during intercourse and increase infertility," said Agarwal, director of UC San Diego Health System's Center for Endometriosis Research and Treatment (CERT), a one of a kind, multidisciplinary program in Southern … Continue reading
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