Read between the lines- You might die on the toilet seat
Mon Apr 9 22:02:00 EDT 2007
Reuters reported that GlaxoSmithKline PLC and its partner Adolor Corporation announced their experimental drug to treat constipation due to opioid painkillers was linked to higher risk of heart attacks and other serious heart problems, fractures and skin cancers in a late-stage trial. The drugmakers announced that they had suspended other trials of the drug, called Entereg. The companies said the negative findings came from a year-long Phase III study of Entereg involving 805 patients experiencing bowel dysfunction as a result of taking opioids for treatment of chronic non-cancer pain. The trial showed that 2.6% of patients treated with Entereg suffered cardiovascular events including heart attack, compared with 1.1% of placebo patients. Trials of Entereg as a treatment for constipation due to cancer pain and shoulder surgery were also halted and the company withdrawn plans to conduct the additional Phase III study that was expected to fulfill a request from U.S. regulators for additional safety data.