Category Archives: Drug Side Effects

A new study suggests stem cells may be able to act as a shield to protect the body from the harmful side effects of chemotherapy, the BBC News reported. As chemotherapy drugs attempt to kill cancer drugs, they can also affect the bone marrow and other healthy tissues. In a new study, however, researchers from the Fred Hutchinson Cancer Research Center in Seattle were able to use genetically modified stem cells to protect the bone marrow. The bone marrow is very susceptible to chemotherapy, and in response to the treatment, produces less blood cells. This leaves the body more prone to infection and fatigue. Stem cell shielding appeared to stave off some of these negative side effects. Researchers took bone marrow from patients with brain cancer and isolated the stem cells. They infected the cells with a virus which carried a gene to protect the cells against a chemotherapy drug, and then re-implanted the cells into the patients. "We found that patients were able to tolerate the chemotherapy better, and without negative side effects, after transplantation of the gene-modified stem cells than patients in previous studies who received the same type of chemotherapy without a transplant of gene-modified stem cells, … Continue reading →

The U.S. Food and Drug Administration says doctors need to reassess which women are likely to benefit from popular bone-building drugs, given the lack of evidence showing that taking them for the long term really helps and the possibility that they put some women at risk for rare but serious side effects. In a report published in the New England Journal of Medicine on Wednesday, the U.S. Food and Drug Administration raised concerns about the potential for some serious side effects in women taking bone-building drugs called bisphosphonates, specifically Fosamax, Actonel and Reclast. The published findings are not new. In 2011, the agency voiced concerns that taking the drugs long-term may actually make bones weaker and increase the risk of rare but serious side effects such as atypical fractures of the thigh bone, esophageal cancer and osteonecrosis of the jaw, a rare but painful condition in which the jaw bone crumbles. To investigate, the FDA reviewed data from women who had taken the drugs for six to 10 years. In Wednesday's report, the agency repeated its 2011 conclusions: Women without osteoporosis seem to get few to no benefits to their bones from taking the drugs beyond five years. In light … Continue reading →

PASADENA, Texas, May 7, 2012 /PRNewswire/ --Experts estimate nearly 30 million Americans, approximately 10 percent of the population, take some form of cholesterol-lowering drug, also known as statins, under brands such as Lipitor, Zocor, Pravachol, and Crestor. Statins are among the most widely prescribed drugs in the United States and cardiologists agree that they remain the most effective long-term treatment for cholesterol patients in the high-risk category. However, many patients are not aware that through regular statin therapy they may be depleting their bodies of valuable vitamins and nutrients essential for healthy living. The depletion may be associated with an increasing number of side effects exhibited by statin patients and relief from these side effects is not commonly known. (Logo: http://photos.prnewswire.com/prnh/20120507/SF00557LOGO) In the past, statins have generally been considered to be safe, however, as the population of statin users continues to rapidly increase, statin studies continue to emerge showing that there is also a significant increase in the number of side effects, such as chronic fatigue and muscle pain. In fact, studies show that 10 to 20 percent of patients treated with statins complain of muscle symptoms and in rare instances use may result in serious muscle damage with myositis, … Continue reading →

A leading public health advocacy group has suggested the Food and Drug Administration (FDA) approve a comprehensive system for tracking adverse reactions and dangerous side effects of prescription drugs once they reach the U.S. market. According to a HealthDay News report on a new study from the Institute of Medicine, the group recognizes that a public clearinghouse for easily accessible information on the potential dangers of prescription drugs does not exist. In some countries, the public and physicians have access to a database which tracks reported side effects and adverse reactions to drugs. Domestically, patients are left to rely upon the recommendations of their physicians or through their own research from a variety of sources. Physicians rely on information they glean from medical journal reports and from colleagues as well as representatives of drug companies for the latest information on potentially dangerous drugs. In its study, Institute of Medicine suggested the FDA work to create a publicly-accessible database tracking these reports concerning prescription drugs. The database should, according to the report, contain a risk- and benefit-assessment plan for each drug and that information should include data from the time the drug reaches the market until the time it is removed. … Continue reading →

Staff walk among the new buildings at the the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland, November 5, 2009. Credit: Reuters/Jason Reed WASHINGTON | Fri May 4, 2012 1:52pm BST WASHINGTON (Reuters) - U.S. drug reviewers said Regeneron Pharmaceuticals Inc's drug to prevent gout flares worked, but questioned its side effects and whether it did enough to help patients. The Food and Drug Administration staff on Friday said the injectable drug, called Arcalyst, was meant to be used for only 16 weeks to prevent gout flares - the first treatment for the condition with such a limited timeline. The FDA staff review comes ahead of an advisory panel of outside experts, which will vote on whether to recommend the drug next Tuesday. The FDA will make a final decision by July 30, taking into account the panel's recommendations. Regeneron's drug, known generically as rilonacept, is already approved to treat a group of rare genetic auto-inflammatory diseases. But the company is hoping to expand its use to prevent gout flares in people starting uric acid-lowering therapy. Gout is a painful condition that occurs when the bodily waste product, uric acid, is deposited in the joints and soft … Continue reading →

Editor's Choice Main Category: Cardiovascular / Cardiology Also Included In: Multiple Sclerosis Article Date: 27 Apr 2012 - 13:00 PDT email to a friend printer friendly opinions Current Article Ratings: 2 (1 votes) The Agency's Committee for Medicinal Products for Human Use (CHMP) recommends that patients' that are deemed necessary to receive Gilenya should have their heart activity monitored for a minimum of one night after taking the first dose of Gilenya, and that doctors should seek advice on appropriate monitoring from a cardiologist. The new recommendations also include that all patients who start Gilenya therapy should have their heart activity monitored prior to taking the first dose and continuously for a minimum of six hours afterwards, whilst those whose heart rate is lowest six hours after receiving the first dose should be monitored for at least two hours extra. Patients developing considerable clinical heart problems like bradycardia (low heart rate) or atrioventricular (AV) block, a conductivity problem in the heart, should be monitored at least overnight and until the problems have been resolved. Since March 2011, Gilenya, the first disease-modifying MS treatment available as an oral formulation, has been authorized in the EU to treat relapsing-remitting MS in patients … Continue reading →

Drugs targeting the incretin system such as dipeptidyl peptidase-IV (DPP-IV) inhibitors are likely to account for the biggest share of the growing market due to their high safety and efficacy profiles. Incretin mimetics Glucagon-like-1 (GLP-1) agonists will also be able to garner a significant share of the diabetes market. New York, NY (PRWEB) April 24, 2012 According to new research available from Marketsensus, there are a number of molecules currently in development for the treatment of diabetes. The annually increasing prevalence and incidence of diabetes will be the key driving factors for the growth in the value of the diabetes market over the next few years. Research shows that products currently in the market do not serve the unmet need that exists in terms of safety and patient compliance and so the market continues to present opportunities for stronger pipeline candidates. However, for a company to capture this unmet need, it will need to overcome prevailing product weaknesses and adverse effects. These are the biggest challenges currently hindering most pipeline products. Drugs targeting the incretin system such as dipeptidyl peptidase-IV (DPP-IV) inhibitors are likely to account for the biggest share of the growing market due to their high safety and … Continue reading →

Posted by Paul NapoliApril 23, 2012 9:33 PM The U.S. Food and Drug Administration (FDA) has announced that labeling for the prescription drugs Propecia and Proscar will be updated to include information about sexual side effects that could persist after discontinuing the drug. Physicians prescribe Propecia (finasteride 1mg) for the treatment of male pattern hair loss and Proscar (finasteride 5mg) for treatment of symptoms of an enlarged prostate condition called benign prostatic hyperplasia (BPH). The pharmaceutical company Merck & Co., Inc. manufactures both drugs. More than a million men have used Propecia since it came on the market in 1998. Labeling changes include: Previous Propecia labeling said sexual side effects were reversible and disappeared after discontinuation of the drug. Dr. Anthony D'Amico, of Brigham and Women's Hospital in Boston, told HealthDay News that the revised labels contain "an important message that people need to hear." Particularly because Propecia is used by 20- and 30-year-olds for hair loss and these are people of childbearing age, so if they are getting issues with fertility that a big issue, D'Amico said. The FDA said the Propecia labeling change comes after reviewing 421 postmarketing reports of sexual dysfunction submitted to the agency between 1998 … Continue reading →

Researchers control drug side effects for treatment gains in phase I trial Newswise CHICAGO - A pair of targeted therapies shrank tumors in some patients with treatment-resistant Ewing's sarcoma or desmoplastic small-round-cell tumors, according to research led by investigators from The University of Texas MD Anderson Cancer Center reported at the AACR Annual Meeting 2012. Five of 17 Ewing's sarcoma patients responded to the combination, with two achieving complete responses, one for 27 weeks. The researchers noted that the ability to manage patients' treatment-related side effects is vital to maintaining the therapy and slowing disease progression. The study was published simultaneously in Clinical Cancer Research, a journal of the American Association for Cancer Research. Ewing's sarcoma primarily affects the bones and occurs most often in teenagers and young adults and relapse is common, said lead researcher Aung Naing, M.D., assistant professor in MD Anderson's Department of Investigational Cancer Therapeutics. Researchers used a combination of cixutumumab, a human IgG1 monoclonal antibody that targets insulin growth factor receptor 1 (IGF-1R), and temsirolimus, an agent that inhibits mTOR, or "mammalian target of rapamycin". The two drugs address molecular pathways that cause cell proliferation and survival, abnormal blood vessel growth and resistance to chemotherapy … Continue reading →

Public release date: 31-Mar-2012 [ | E-mail | Share ] Contact: Scott Merville smerville@mdanderson.org 713-792-0661 University of Texas M. D. Anderson Cancer Center CHICAGO - A pair of targeted therapies shrank tumors in some patients with treatment-resistant Ewing's sarcoma or desmoplastic small-round-cell tumors, according to research led by investigators from The University of Texas MD Anderson Cancer Center reported at the AACR Annual Meeting 2012. Five of 17 Ewing's sarcoma patients responded to the combination, with two achieving complete responses, one for 27 weeks. The researchers noted that the ability to manage patients' treatment-related side effects is vital to maintaining the therapy and slowing disease progression. The study was published simultaneously in Clinical Cancer Research, a journal of the American Association for Cancer Research. Ewing's sarcoma primarily affects the bones and occurs most often in teenagers and young adults and relapse is common, said lead researcher Aung Naing, M.D., assistant professor in MD Anderson's Department of Investigational Cancer Therapeutics. Researchers used a combination of cixutumumab, a human IgG1 monoclonal antibody that targets insulin growth factor receptor 1 (IGF-1R), and temsirolimus, an agent that inhibits mTOR, or "mammalian target of rapamycin". The two drugs address molecular pathways that cause cell proliferation … Continue reading →