Bristol-Myers Squibb and AstraZeneca are developing a new diabetes medication, but the experimental drug, although found to be effective in the two-year study, left participants with increased bladder and breast cancers, said Reuters.
Of the <"http://www.yourlawyer.com/practice_areas/defective_drugs">dapagliflozin studies completed, 1.4 percent of patients treated with the drug developed some form of cancer, versus 1.3 percent of the control group patients, according to Elisabeth Bjork, vice president of development for dapagliflozin at AstraZeneca, wrote Reuters. In all, 9 bladder cancers were found in 5,478 patients treated with dapagliflozin; 1 bladder cancer was seen in the 3,156 patients control group, noted Reuters. Of those studied, 6 of 10 tested with hematuriaâ€”blood in the urineâ€”at the start of the trial; five were diagnosed within the first year, said Reuters.
The drug makers noted that 9 breast cancer cases took place in 2,223 women taking dapagliflozin, versus 1 case in the control group of 1,053 women; all of the breast cancers were diagnosed within the first year of study, said Reuters.
Both drug makers filed in early 2011 for United States and European regulatory approval of dapagliflozin; a U.S. Food and Drug Administration (FDA) advisory panel will be reviewing the application on July 19, said Reuters.
Dapagliflozin is likely the first drug in an emerging diabetes drug class to block glucose absorption into the bloodstream via the kidneys, said Reuters. This process will enable greater amounts of sugar to excrete via urine; however, this is might be linked to the increased cancer risk. Because dapagliflozin leaves more sugar in the urine, it could be acting as a bacterial and pathogenic nutrient, which could lead to infections, said Elisabeth Svanberg, vice president of development for dapagliflozin at Bristol-Myers, wrote Reuters.
Urinary tract infections were found in 8 percent of the Type 2 diabetes patients treated with placebo and generic metformin in the study versus 8 percent on 2.5 mg dose of dapagliflozin plus metformin, 8.8 percent of patients on a 5 mg dose, and 13.3 percent receiving dapagliflozin 10 mg, said Reuters. Genital infections were seen in 5.1 percent of receiving placebo plus metformin, 11.7 percent on the lowest dose of dapagliflozin plus metformin, 14.6 percent on the 5 mg dose, and 12.6 percent of on highest dapagliflozin dose, added Reuters. Other side effects, wrote Reuters, were â€œback pain, influenza, diarrhea, headache, nasopharyngitis, upper respiratory tract infection, renal impairment or failure, and events of hypoglycemia,â€ citing data presented at the yearly American Diabetes Association meeting.
Meanwhile, weâ€™ve been following the issue of <"http://www.yourlawyer.com/topics/overview/actos">Actos, a drug approved for the treatment of Type 2 diabetes, and its links to increased bladder cancer, which prompted a few medical societies to speak out. The Endocrine Society, American Association of Clinical Endocrinologists, and American Diabetes Association urge patients with diabetes to remain on their prescribed medications unless told to discontinue that medication on the advice of their physicians and also say that patients follow FDA guidance, which advised that, when taking Actos, there is the potential for increased risk of bladder cancer and that patients should not take this medication if receiving bladder cancer treatment.
The societies also suggest patients immediately speak to their physicians if they exhibit any bladder cancer symptoms, such as blood or red color in their urine, an urgent need to urinate, pain when urinating, or back or lower abdominal pain. Patients are also urged to read the Medication Guide supplied with Actos (pioglitazone) medication and to speak to their physicians if they have questions with this medication, said Science Daily.