Category Archives: Drug Side Effects

CAMBRIDGE, Mass. (AP) -- Ariad Pharmaceuticals Inc. said Friday that the Food and Drug Administration approved its pill Iclusig as a treatment for two rare types of leukemia, but shares of the company tumbled after regulators required the addition of warning label alerting patients to potentially serious side effects. Iclusig, which was developed under the name ponatinib, was approved for use against treatment-resistant chronic myeloid leukemia and for patients with acute lymphoblastic leukemia with a type of chromosome abnormality. It is Ariad's first approved product. The company says approximately 5,000 cases of chronic myeloid leukemia are diagnosed in the U.S. each year. The FDA approved the drug sooner than expected, as its decision wasn't due until late March. European Union regulators are also reviewing the drug and are expected to make a decision in the third quarter of 2013. Federal regulators will require Ariad to include a boxed warning that Iclusig may cause blood clots and liver toxicity. Citi Investment Research analyst Jonathan Eckard, who rates the stock a "Buy," noted that he doesn't expect the warning to dramatically affect the drug's adoption since "physicians treating these patients are likely broadly familiar with the adverse effects caused by this disease … Continue reading →

LONDON (Reuters) - European regulators recommended against approval of Sanofi and Isis Pharmaceutical's Kynamro drug for treatment of a rare genetic disorder that causes unusually high cholesterol. The European Medicines Agency said it was concerned about the medicine's safety, noting that a high proportion of patients stopped taking it within two years, mainly due to side effects such as flu-like symptoms, injection site reactions and liver toxicity. The European rebuff contrasts with a green light for the drug, known generically as mipomersen, by a U.S. advisory panel in October. Sanofi's Genzyme unit said it was disappointed by the decision and planned to request a re-examination. A Sanofi spokeswoman said the company expected feedback from the regulator in the second quarter of 2013. Isis founder and Chief Executive Stanley Crooke said on a conference call with analysts he was still optimistic on securing approvals in both the United States and Europe. "Even though I cannot address the specific concerns of the (EU) committee ... I can say that each issue raised by the (committee) was thoroughly reviewed by the FDA," Crooke said. "We do not believe that today's opinion should have a negative impact elsewhere." At 1514 GMT Sanofi shares were … Continue reading →

(Reuters) - The U.S. Food and Drug Administration on Friday granted earlier-than-expected approval to Ariad Pharmaceuticals Inc's drug for two rares types of leukemia, but is requiring that patients be warned of potential side effects, sending the company's shares down nearly 20 percent. The drug, given the brand name Iclusig, was approved three months ahead of time under the FDA's accelerated program for earlier access to promising new drugs. The FDA is requiring a so-called "blackbox" on the drug's label warning of the potential for arterial thrombotic events and liver toxicity, according to Ariad. "While the blackbox warning may impact the pace of adoption initially in the community setting, we expect high volume academic centers to quickly look past the warning," BMO Capital Markets analyst Jim Birchenough said in a research note. The approval covers use of the drug, also known as ponatinib, to treat chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia, two types of rare blood and bone marrow cancers, in patients who had been treated with older drugs. "We would be buyers of Ariad into the 2013 Iclusig launch," Guggenheim analyst Bret Holley said in a research note. He forecast a relatively rapid uptake of … Continue reading →

Washington, Dec 13 (IANS) Researchers have now discovered a drug that could ease out depression without any side-effects. An experimental drug AZD6765 eased hard-to-treat depression within hours, minus side-effects, in a clinical trial conducted by the National Institute of Health (NIH). Prescription anti-depressants, working through the brain's serotonin system, take weeks to work, which might prompt severely depressed to commit suicide. Ketamine also works in hours, but its usefulness is limited by its potential for side-effects, including hallucinations. It is being studied mostly for clues to how it works. "Our findings serve as a proof of concept that we can tap into an important component of the glutamate pathway to develop a new generation of safe, rapid-acting practical treatments for depression," said Carlos Zarate, of the NIH's National Institute of Mental Health, which conducted the research, the journal Biological Psychiatry reported. AZD6765, like ketamine, works by blocking glutamate binding to a protein on the surface of neurons, called the NMDA receptor. It is a less powerful blocker of the NMDA receptor, which may be a reason why it is better tolerated than ketamine, according to an NIH statement. About 32 percent of treatment-resistant depressed patients infused with ASD6765 showed a … Continue reading →

Despite the popularity of German drug manufacturer Boehringers Pradaxa blood-thinning medication, regulators worldwide have reported hundreds of deaths associated with the drugs serious side effects, according to a Dec. 11 Bloomberg report. New York, NY (PRWEB) December 12, 2012 The plaintiffs allege, according to Bloomberg, that Boehringer knew about those potentially serious Pradaxa side effects, including patient bleed-outs. The FDA approved Pradaxa in 2010 as a blood-clot prevention alternative to the decades-old warfarin. But by the following year, the FDA had received reports of 542 deaths and 3,781 side-effect incidents tied to the drug, according to Bloomberg. There were reports outside the United States as well. After European regulators said that 256 deaths were linked to Pradaxa, Boehringer admitted that there were 260 deaths associated with the medication. In New Zealand in 2011, there were dozens of reported deaths as well. Patients trusted that Pradaxa would work as indicated, but their trust has been damaged by these reports, said Rochelle Rottenstein, principal of the Rottenstein Law Group. I encourage anyone who has experienced serious Pradaxa side effects or who knows anyone who has to contact a lawyer today. The Rottenstein Law Group maintains a comprehensive website with a wealth of … Continue reading →

Take One and Call Me in the Morning If You're Still Alive A video produced by the lawyers at Console Hollawell used to supplement a study done of various prescription drugs and their side effects. You can find the full article here: http://www.consoleandhollawell.comFrom:ConsoleAndHollawellViews:1 0ratingsTime:01:19More inEducation Read more from the original source: Take One and Call Me in the Morning If You're Still Alive - Video … Continue reading →

Washington, Dec 10 (IANS) A new drug halves the risk of serious and often deadly side-effect of lifesaving bone marrow transplant treatments, according to a new finding. The study combined vorinostat with standard drugs given after transplant, bringing down the percentage of patients developing graft-versus-host disease (GVHD) to 21, compared to 42 percent of patients who did with standard medications alone. "GVHD is the most serious complication from transplant that limits our ability to offer it more broadly. Current prevention strategies have remained mostly unchanged over the past 20 years," says study co-author Sung Choi, assistant professor of paediatrics at the University of Michigan Medical School. GVHD is characterized by the transplanted stem cells producing immune cells that attack the recipient's body. The new immune cells treat the patient's normal cells as foreign invaders and begin to damage the patient's organs, according to a Michigan statement. Vorinostat is currently approved by the US Food and Drug Administration to treat certain types of cancer. But Michgian researchers, led by senior study author Pavan Reddy, found in lab studies that the drug had anti-inflammatory effects as well. Participants were older adults undergoing a reduced-intensity bone marrow transplant with cells donated from a … Continue reading →

Psychiatry Exposed! With thanks- Excerpt from http://www.dcstanley.hubpages.com: "Patients are nothing but riff-raff. The only useful purposes they serve are to help us earn a living and to provide learning material. In any case, we cannot help them." Sigmund Freud, an icon of psychiatry, considered to be the Father of the Psychotherapy Movement, whose ideas saturate later theories and therapies, is quoted above. Psychiatrists and pharmaceutical companies would prefer you didn't know or have easy access to information about the crippling and even lethal effects of psychotropic drugs. The complex medical jargon used to describe the drugs and their "adverse effects" can often put consumers off from even looking. While billions of tax dollars are paid each year to fight the "War on Drugs," psychiatrists are dreaming up new mental illnesses to fund a multi-billion dollarlegal drug industry. The direct result is a fast escalating, worldwide consumption of their addictive, mind-altering drugs. They would like you to believe that there is an epidemic of mental disease mdash;and that mind-altering drugs are the cure. They market to the public that their drugs are indispensable to the problems of everyday living. Yet, psychiatrists admit they do not know the cause of or … Continue reading →

The Truth About Psychiatry and the Drugs They Prescribe CCHR (WITH THANKS) Excerpt from: http://www.dcstanley.hubpages.com; Quote from Sigmund Freud " Patients are nothing but riff-raff. The only useful purposes they serve are to help us earn a living and to provide learning material. In any case, we cannot help them." Sigmund Freud, an icon of psychiatry, considered to be the Father of the Psychotherapy Movement, whose ideas saturate later theories and therapies, is quoted above. Psychiatrists and pharmaceutical companies would prefer you didn't know or have easy access to information about the crippling and even lethal effects of psychotropic drugs. The complex medical jargon used to describe the drugs and their "adverse effects" can often put consumers off from even looking. While billions of tax dollars are paid each year to fight the "War on Drugs," psychiatrists are dreaming up new mental illnesses to fund a multi-billion dollarlegal drug industry. The direct result is a fast escalating, worldwide consumption of their addictive, mind-altering drugs. They would like you to believe that there is an epidemic of mental disease mdash;and that mind-altering drugs are the cure. They market to the public that their drugs are indispensable to the problems of … Continue reading →

The Drug Risk Resource Center is the Webs largest source for information on prescription drug warnings, side effects and legal news. Visit http://www.DrugRisk.com Orlando, FL (PRWEB) December 06, 2012 The news for Merck comes as litigation surrounding their popular NuvaRing contraceptive device has grown to 1,028 cases, according to the 2012 Statistical Analysis from the Judicial Panel on MultiDistrict Litigation.** The formal case is known as In re: NuvaRing Products Liability Litigation, No. 08-md-1964, JPML, Eastern District Missouri. Anyone who suffered blood clots, stroke, DVT or pulmonary embolism after using NuvaRing is urged to contact the DrugRisk Resource Center or speak with a lawyer about their legal rights as soon as possible. A NuvaRing lawsuit may be possible to recover damages. Experts have related vaginal rings like NuvaRing to higher blood clot risks than with traditional birth control pills. The British Medical Journal published a Danish study on May 10, 2012 linking vaginal rings like NuvaRing to as much as a 90% increased risk of blood clots over oral contraceptives. On June 14, 2012, the New England Journal of Medicine also published a study finding vaginal ring contraceptives could relate to a 2.5 to 3-fold increased risk of blood clots. … Continue reading →