Category Archives: Drug Side Effects

* T-DM1 superior to Tykerb plus Xeloda in Phase III study * Filing planned for Europe (Chicago Options: ^REURUSD - news) and U.S. this year * T-DM1 delivers toxic payload with fewer side effects (Adds details on drug, reduced side effects) ZURICH, March 30 (Reuters) - Roche said patients with an aggressive type of breast cancer lived longer after taking its experimental "armed antibody" drug without the disease worsening than those on a mix of GlaxoSmithKline (Other OTC: GLAXF.PK - news) drug Tykerb and Roche's Xeloda. The positive results from the first Phase III trial of the medicine - dubbed T-DM1 - clears the way for it to be submitted to European and U.S. authorities for approval this year, boosting prospects for a key asset in the Swiss firm's pipeline. Roche has been developing T-DM1 with ImmunoGen (NasdaqGM: IMGN - news) as a successor to its blockbuster Herceptin, which is expected to generate sales of around $6 billion this year. A key advantage of T-DM1 over Herceptin is the fact that it causes fewer adverse side effects like hair loss and low white blood cell counts. It combines trastuzumab, an antibody and the active ingredient in Herceptin, with the agent … Continue reading →

The Department of Pharmaceuticals' decision to stick to cost-based pricing will put drugs out of reach of the poor. Market pricing will improve access to medicines by spurring competition in the industry. March 30, 2012: The figures just don't add up for Nathu Ram, a daily-wage earner, who supports a family of five. Eking out a meagre existence on Rs 200 a day, he finds himself in an inescapable predicament: either to feed the family or foot the medical bills of his wife, diagnosed with breast cancer recently. He does try to balance it out, but even concessional treatment and medicines remain out of bounds. Nathu Ram is not an isolated case. Millions of people in India don't have access to essential medicines. Just making drugs cheaper doesn't help their case. Nor does rhetoric! It's time we understood why the well-drafted National Pharmaceutical Pricing Policy (NPPP) 2011 might not meet its avowed objectives. Directed by the Supreme Court, the Department of Pharmaceuticals (DoP) set the tone for the NPPP 2011 with a focus on improving access to essential medicines and encouraging industry competition through a market-based pricing policy. But since then, there has been a series of flip-flops on its … Continue reading →

CRESSKILL, N.J., March 29, 2012 /PRNewswire/ --Even after published studies described Avandia's dangerous side effects, Type 2 diabetes sufferers, who are at the highest risk of developing fatal heart disease, were prescribed the drug in order to lower their blood sugar levels. Tens of thousands of suits have been settled by GlaxoSmithKline to resolve claims that its drug Avandia increased the risk of heart attack in Type 2 diabetes patients. Plaintiff attorneys with Avandia settlements, who are still waiting to get paid, are encouraged to contact RD Legal Funding, LLC ("RD Legal"), one of the nation's leading providers of lawsuit funding to attorneys. (Logo: http://photos.prnewswire.com/prnh/20110803/NY45278LOGO ) Avandia (rosiglitazone) proved a bitter pill for Type 2 diabetes sufferers who were already at increased risk of heart attack. In Type 2 diabetes, either the body does not produce enough insulin or the cells ignore the insulin which the body requires to use glucose for energy. Avandia helped control diabetics' blood sugar by making the body more sensitive to its own insulin. First approved for use in the United States in 1998, Avandia became the world's best-selling drug for treating Type 2 diabetes. Heart disease and stroke are already the number one causes … Continue reading →

Public release date: 29-Mar-2012 [ | E-mail | Share ] Contact: Karen Kreeger karen.kreeger@uphs.upenn.edu 215-349-5658 University of Pennsylvania School of Medicine PHILADELPHIA A Penn- and MIT-led team explained how rapamycin, a drug that extends mouse lifespan, also causes insulin resistance. The researchers showed in an animal model that they could, in principle, separate the effects, which depend on inhibiting two protein complexes, mTORC1 and mTORC2, respectively. The study suggests that molecules that specifically inhibit mTORC1 may combat age-related diseases without the insulin-resistance side effect, which can predispose people to diabetes. Senior author Joseph A. Baur, PhD, assistant professor of Physiology, Perelman School of Medicine, University of Pennsylvania, and colleagues at the Whitehead Institute for Biomedical Research and Broad Institute, Massachusetts Institute of Technology, in Cambridge, MA, describe their work in this week's issue of Science. Baur is also a member of Penn's Institute for Diabetes, Obesity, and Metabolism. "The hope is that in the future, we will be able to develop molecules that target mTORC1 specifically, separating out the beneficial effects of rapamycin on aging and disease, and leaving behind the insulin-resistance side effect," says Baur. "Our results demonstrate that reduced mTORC1 signaling is sufficient to extend lifespan and mTORC2 … Continue reading →

It was a bittersweet discovery: a drug that extends life but at the cost of causing diabetes. Now the drug's dual nature has been teased apart, raising the prospect of a new life-prolonging drug without the harmful side effects. Rapamycin is regularly given to prevent transplant rejection and treat cancer. Previous studies have also shown that it extends the life of animals, but simultaneously causes glucose intolerance a side effect reported in humans, too. David Sabatini of the Whitehead Institute for Biomedical Research in Cambridge, Massachusetts, and colleagues, gave the drug to strains of mice that had genes for certain proteins silenced. They found that rapamycin acts on two important nutrient-sensing proteins called MTORC1 and MTORC2. Its effect on the gene for MTORC1 prolongs life, while its action on MTORC2 causes diabetes. Sabatini's team is now developing variants of rapamycin that act only on the gene for MTORC1. "If we could just target MTORC1, we could preserve longevity effects and get rid of the unwanted side effects," he says. Journal reference: Science, DOI: 10.1126/science4.1215429 If you would like to reuse any content from New Scientist, either in print or online, please contact the syndication department first for permission. New Scientist … Continue reading →

A study of an experimental blood thinner from Merck showed that while the drug helped thwart heart attacks it raised the risk of brain bleeding, a side effect that could stymie its approval. The three-year study of 26,449 patients who had heart attack, stroke or leg artery disease, found those who got Mercks vorapaxar along with standard therapy were 13 percent less likely to have another heart attack or die from cardiovascular causes than those on standard treatment. More patients on the drug also had serious bleeding, according to data reported yesterday at the American College of Cardiology meeting in Chicago. The findings are unlikely to be good enough to get U.S. marketing approval, said Steven Nissen, a cardiologist at the Cleveland Clinic who wasnt involved in the study. New studies are needed to prove vorapaxar can be used in some patients without excess bleeding, he said. "The results are disappointing," Nissen said. "The bottom line is it is extremely difficult to make the case that the benefits exceed the risks here." In January 2011, Merck narrowed the scope of the trial to stop testing the drug in stroke patients and halted another vorapaxar trial entirely after doctors monitoring the … Continue reading →

Washington, Mar 26 : Two prevalent drug therapies - rifaximin and lubiprostone - have been identified as having the fewest side effects for treating Irritable Bowel Syndrome, according to a study. Patients with irritable bowel syndrome often experience abdominal pain or cramps, excess gas or bloating and visible abdominal distension. Many drug therapies cause troubling side effects of their own, including nausea, insomnia, palpitations and decreased appetite. The findings are based on an analysis of more than two dozen large-scale clinical trials. "For the millions of patients who suffer from IBS, effective treatment options have been very scarce," said Dr Mark Pimentel, a lead author of the study and director of Cedars-Sinai's Gastrointestinal Motility Program. Pimentel and the other researchers analysed common treatments for IBS. For diarrhoea forms of the condition, they evaluated tricyclic antidepressants; alosetron, a drug that slows movement of stool in the gut; and rifaximin, an antibiotic that stays in the gut and is used to treat traveller's diarrhoea and hepatic encephalopathy. For constipation forms of IBS, the researchers examined antidepressants known as serotonin reuptake inhibitors and lubiprostone, a drug that promotes gut secretion. The study found that for every 2.3 patients who benefited from tricyclic antidepressants, … Continue reading →

An experimental drug that works in a novel way to lower cholesterol proved even more effective than statins and had few undesirable side effects, newly released data shows. The drug works by modifying the way cholesterol levels are naturally controlled. A protein produced in the liver helps limit the amount of LDL, or "bad" cholesterol, that liver cells can remove from the bloodstream. The new drug, called REGN727, is a monoclonal antibody, made in a laboratory, that blocks the action of that protein. "About 5 to 10 percent of people can't tolerate statins at all, and more can't tolerate higher doses," said Dr. Evan Stein, director of the Metabolic and Atherosclerosis Research Center in Cincinnati and lead author of the trials. "It's still early in development, but for them this is potentially a most promising alternative." The studies were published in The New England Journal of Medicine. The unusual results have been greeted with cautious optimism. "The study shows that the drug has incredibly potent effect in lowering cholesterol," said Dr. Mario J. Garcia, chief of cardiology at Montefiore Medical Center in New York City, who was not involved in the research. "Even though this is very exciting, and perhaps … Continue reading →

Public release date: 26-Mar-2012 [ | E-mail | Share ] Contact: Tracie White traciew@stanford.edu 650-723-7628 Stanford University Medical Center STANFORD, Calif. The under-reporting of the possible side effects of heart damage from cancer drugs puts patients at an increased risk for heart failure, according to two researchers at the Stanford University School of Medicine. In a commentary that will be published online March 26 in the Journal of Clinical Oncology, the Stanford researchers say urgent reforms are needed to standardize measurements of the potential toxicity of cancer drugs during clinical trials in order to prevent the publication of misleading results, as have appeared in such prestigious scientific journals as the Lancet and the New England Journal of Medicine. "It's a major issue when adverse events aren't being counted in clinical trials, and this has led to a profound underappreciation of the risk for heart failure and other adverse cardiac events," said Ronald Witteles, MD, assistant professor of cardiovascular medicine and the first author of the commentary. The two researchers Witteles, a cardiologist at Stanford Hospital & Clinics, and co-author Melinda Telli, MD, assistant professor of oncology and a member of the Stanford Cancer Institute became concerned when they started seeing … Continue reading →

Mar 26, 2012 4:41pm Yana Svetlichnaya, M.D. reports: A new blood thinner offers simpler and safer treatment for pulmonary embolism, a deadly condition in which a lung blood vessel becomes blocked by a blood clot. Venous blood clots have long been treated with warfarin, a drug fraught with food and drug interactions. On top of keeping a strict diet, patients must comply with frequent blood tests and complex dosing schedules. But a new study suggests the drug rivaroxaban performs as well as warfarin in treating existing blood clots in the lung with less monitoring and fewer side effects. You dont have to go to the lab to monitor. Its a fixed dose. It is as effective, and it looks safer, said study authorDr. Harry Bueller, professor of vascular medicine at the American Medical Center in Amsterdam. Patients treatedwith rivaroxaban had similar rates of clot recurrence as patientstreated with warfarin. But they had a lower rate of bleeding, with nearlyhalf as many major bleeds as patients taking warfarin, according to the trial results presented at the American College of Cardiology meeting in Chicago. Bueller said rivaroxaban may soon replace warfarin in treating venous blood clots because its easier to manage and … Continue reading →