New anaemia med warnings
5/14/2007 Cape Town, South Africa staff Health24.com A US Food and Drug Administration advisory panel has called for new warnings and additional safety studies on anaemia drugs commonly used to treat patients undergoing kidney dialysis or chemotherapy. These medications have been the subject of controversy since some of their dangerous side effects - including the risk of heart attacks and stroke - came to light earlier this year. In March, the FDA issued stronger label warnings for the popular drugs. On Thursday, the agency's advisory panel of experts voted 15-2 in favour of new prescribing restrictions and 17-0 for new clinical trials to prove the safety of Amgen's Aranesp and Johnson & Johnson's Procrit, Bloomberg reported. "Many of us are concerned on the committee and have a lot of questions," said advisory panel chairwoman Gail Eckhardt, an oncologist at the University of Colorado in Aurora, according to Bloomberg. Insufficient evidence Eckhardt said the questions concerned the design of trials, why regulators have limited access to results from company studies, and why the drugs have been marketed for improving quality of life if there isn't sufficient evidence for the claim. Amgen, of Thousand Oaks, California, claims that 4 million patients have taken the medicines since they were introduced in 1989, and more than 9 000 people have been studied in clinical trials with cancer patients, the Bloomberg report said. "We want to consider the totality of the evidence and consider what's best for patients," Roger Perlmutter, Amgen's head of research and [...]