Category Archives: Drug Side Effects

LONDON (Reuters) - Europe's drug regulator has started an infringement procedure against Switzerland's Roche to investigate its alleged failure to properly report tens of thousands of potential drug side effects. If found guilty, the world's biggest maker of cancer medicines could be fined up to 5 percent of annual EU turnover which totaled 12.8 billion francs ($13.8 billion) in 2011, or 640 million francs. It was first time the London-based European Medicines Agency (EMA) has launched such proceedings since legislation came into force five years ago. "The agency will report the outcome of its investigation to the European Commission who may impose fines or periodic penalty payments ... if it finds that Roche has committed an infringement of its obligations," the EMA said on Tuesday. The issue of drug-safety reporting by Roche was first highlighted by the agency in June after a routine inspection by British investigators found it had failed to fully assess up to 80,000 cases of possible adverse drug reactions. There were some 15,000 deaths among the reports, which may have been due to natural disease progression but may have been connected to the drugs. That led to an immediate probe into public health implications. The latest … Continue reading →

LONDON (AP) Europe's top drug regulator announced Tuesday it is taking action against pharmaceutical giant Roche for allegedly failing to properly report the side effects of 19 drugs being used by U.S. patients. It is the first time the European Medicines Agency has begun a so-called 'infringement proceeding' against a drug maker. European regulations lay out numerous requirements for pharmaceuticals, including reporting suspected side effects and submitting such cases to officials. Eight of the drugs involved are used for the treatment of cancer, including breast cancer. They include Avastin, Herceptin, Tarceva, and Xeloda. The flu drug Tamiflu was also included in the list. British authorities brought the problem to the attention of the European authorities in May after noticing "serious shortcomings" in how Roche AG reported potential side effects. Regulators said about 80,000 reports by consumers of possible adverse effects to drugs sold in the U.S. had not been properly analyzed. Among those reports were over 15,000 deaths, though it was unclear if those deaths were caused by Roche medicines. The regulator said there was no evidence that users of Roche's drugs were at risk. The European Medicines Agency did not state what the side effects were but said it … Continue reading →

The Pradaxa Resource Center is the Webs largest source for information on Pradaxa legal news, research and side effects. Visit http://www.Pradaxa-lawsuits.org Dallas, TX (PRWEB) October 17, 2012 The news comes after an FDA warning on December 7, 2011 that it was investigating Pradaxa after receiving more injury or death reports than expected. USA Today reported on August 19th that the FDA received 3,781 reports of side effects and 542 deaths among Pradaxa users last year, leading all other medications in 2011. Now, a federal judge overseeing Pradaxa lawsuits filed by those injured has entered an order expediting the claim filing process. On October 4, 2012, Judge David Herndon entered a Case Management Order allowing for direct filing of claims into the Pradaxa Federal MDL. http://tinyurl.com/9dfgb6f Anyone affected by internal bleeding or the loss of a loved one after using Pradaxa is urged to speak with a lawyer about their legal rights as soon as possible. Pradaxa is a popular blood thinner prescribed to prevent strokes and blood clots in patients with atrial fibrillation. According to The Wall Street Journal on April 24, 2012, Boehringer Ingelheim has earned more than $1 billion from the drug so far in more than 70 … Continue reading →

CHICAGO (Reuters) - An antibiotic used to treat severe bacterial infections showed promise at treating a highly drug-resistant and deadly form of tuberculosis, U.S. government and South Korean researchers said on Wednesday. The study, published in the New England Journal of Medicine, is the first scientifically rigorous clinical trial of Pfizer's antibiotic linezolid, or Zyvox, in patients with extensively drug-resistant TB (XDR-TB), which is resistant to at least four of the drugs most often used to treat the lung infection. Led by Clifton Barry of the National Institute of Allergy and Infectious Diseases and Sang-Nae Cho, professor of infectious diseases at Yonsei University, South Korea, the study showed the drug was effective when added to patients' current treatments. "The data that were reported are rather impressive," Dr. Anthony Fauci, director of the institute, a part of the National Institutes of Health, said in a telephone interview. However, most of the patients - 82 percent - experienced side effects while on the treatment, which tempered the findings, the team reported. "That is the bad news," Fauci said. "The somewhat encouraging news is that despite the toxicity, when the drug dose was decreased or was temporarily discontinued, the toxic side effects diminished … Continue reading →

Drug delivery research in India will advance with help from New Zealand, with the gift of a highly advanced qNano system to Prof. Rinti Banerjee from the Department of Biosciences & Bioengineering at the Indian Institute of Technology (IIT) in Mumbai. New Zealand nanotechnology company Izon Science gifted the instrument to accelerate advancement of research in the area of nanoparticles for drug delivery. . The gift recognises the path-breaking technology platform and drug delivery mechanism award winning Prof. Rinti Banerjee has developed. The qNano provides the highly accurate information required to aid development of drug delivery systems that could deliver cancer drugs directly to the tumor The qNano system was presented to Prof. Banerjee by Hans van der Voorn, the Executive Chairman of Izon Science. The function held at IIT Bombay was attended by Hon Steven Joyce, New Zealands Science and Innovation Minister, as part of his visit to India with a delegation of New Zealand education and aviation companies. Acting Director of IIT Bombay, Prof. R.K. Malik and Prof. N.S. Punekar, Head of Department of Biosciences & Bioengineering were also present at the occasion. Prof. Banerjee is the winner of numerous awards for her work including most recently the … Continue reading →

Fosamax Lawsuits Currently Pending in New Jersey Superior Court, Atlantic County, Involve Allegations that Long-Term Use of the Drug Caused Plaintiffs to Suffer Serious Fosamax Side Effects, Including Fosamax Femur Fractures and Osteonecrosis of the Jaw (ONJ) New York, New York (PRWEB) October 17, 2012 Fosamax Side Effects 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 ONJ.*** The Fosamax lawsuits currently pending in New Jersey involve both femur fractures and ONJ. In a letter dated, June 4, 2012, Judge Carol Higbee, who is overseeing the Fosamax side effects litigation, stated her intention to schedule bellwether trials for cases involving Fosamax femur fractures. Discovery for Fosamax femur fracture lawsuits is moving forward. Bernstein Liebhard LLP is actively … Continue reading →

NEW YORK (Reuters Health) - A drug approved to prevent seizures may also help obese people lose a few pounds when it's added to therapy and nutritional guidance, a new small trial suggests. But people who took zonisamide also reported more side effects, from nausea and vomiting to anxiety and depression. And two researchers not involved in the study questioned how much the drug would actually help people in the real world. Although zonisamide is only approved by the U.S. Food and Drug Administration for seizures, doctors can prescribe it "off-label" for non-approved purposes. Prior small trials and anecdotal evidence suggested it might help heavy people shed extra pounds. "There is a little bit of weight loss with this drug when it is given for treatment of epilepsy," said lead researcher Dr. Kishore Gadde, from Duke University Medical Center in Durham, North Carolina. That could be because of its effects on serotonin and dopamine, he said. Those two neurotransmitters are known to effect motivation and reward pathways in the brain, including those related to food. Gadde said his team wanted to see if zonisamide could produce weight loss in people without epilepsy, and with the added help of a behavioral … Continue reading →

We have witnessed the devastating side effects of current cancer therapies for far too many years -- we might be able to shrink or destroy cancerous masses or cells, but the effects of blasting an individual with localised radiation or injecting toxic chemicals into their bloodstream are, in themselves, deadly. We're due to wait until till as long as 2030 to see graphene become a drug delivery tool that targets only cancerous cells, but now, a collaborative team at the University of Missouri has proven that radioactive gold nanoparticles are an effective and side effect-free cancer treatment -- at least, that is, in dogs with aggressive prostate cancer. "Dogs represent such a good model because they develop the disease naturally," explains Sandra Axiak-Bechtel, an assistant professor of oncology at the University of Missouri (MU) College of Veterinary Medicine. "It's a disease that normally we don't have a particularly good treatment for so it offers us as veterinarians the opportunity to better and more aggressively treat the disease while preserving their quality of life, and in the future hopefully it will give us a better way of treating men with prostate cancer more aggressively as well." Previous research by Stanford University … Continue reading →

The Pradaxa Resource Center is the Webs largest source for information on Pradaxa legal news, research and side effects. Visit http://www.Pradaxa-lawsuits.org Orlando, FL (PRWEB) October 16, 2012 The news comes after an FDA warning last December that it would investigate the blood thinner Pradaxa after receiving more injury or death reports than expected. USA Today reported on August 19th that the FDA received 3,781 reports of side effects and 542 deaths among Pradaxa users last year, leading all other medications in 2011. Anyone affected by internal bleeding or the loss of a loved one after using Pradaxa is urged to speak with a lawyer about their legal rights as soon as possible. Pradaxa is a popular blood thinner prescribed to prevent strokes and blood clots in patients with atrial fibrillation. According to The Wall Street Journal on April 24, 2012, Boehringer Ingelheim has earned more than $1 billion from the drug so far in more than 70 countries. Due to the number of Pradaxa lawsuits expected, a central court was recently established in Illinois to handle the claims. The case is known as MDL No. 2385, IN RE: Pradaxa Product Liability Litigation, Southern District of Illinois. On September 5, 2012, … Continue reading →

NEW YORK (AP) Abbott Laboratories said Monday that its experimental hepatitis C drug regimen cured 99 percent of patients in a midstage study with the most common and hardest-to-treat type of the disease. Patients who took a three-drug regimen and the drugs Ritonavir and ribavirin had undetectable virus levels after 12 weeks of treatment. The North Chicago, Ill., company says it observed a 93 percent cure rate in a group of patients who were not helped by other treatments. Patients in the trial had genotype 1 hepatitis C, which is the most common type in the Western world and the hardest to treat. The regimen did not include interferon, a standard component of hepatitis C therapy that causes flu-like side effects that can last for months. The study included 77 patients who hadn't been treated before and 41 patients who were not helped by other treatments. Abbott shares rose $2.27, or 3.3 percent, to $71.55 in afternoon trading. The stock has been trading around all-time highs and peaked at $71.99 earlier in the session. Hepatitis C is a virus that can lead to life-threatening liver damage and is the main cause of liver transplants in the U.S. Analysts say the … Continue reading →