New Diabetes Drug May Lead to Bladder and Breast Cancer

July 21, 2011

Dapagliflozin, a new experimental diabetes drug, is already under scrutiny for possibly causing cancer. The drug has not even hit the market yet, however, if approved, it would be the first in a new line of diabetes drugs that treat type 2 diabetes by eliminating access sugar in the urine. Unfortunately, bladder and breast cancer side effect concerns may prevent the drug from ever being sold. Based on the clinical research that our defective drug lawyers reviewed, the new diabetes drug is strikingly similar to other defective diabetes drugs that have led to numerous drug injury lawsuits, posing a serious health risk for consumers.

Dapagliflozin would be a new option for diabetes patients that typically turn to diabetes drugs to reduce the amount of sugar they absorb from food. The drug is being developed by Bristol-Myers Squibb and AstraZeneca, and other major manufacturers such as Johnson & Johnson and Eli Lilly are pursing similar drugs. Unfortunately, the drug's safety and effectiveness is creating major concerns.

The New York Times is reporting that the new diabetes drug is tied to an increased risk of bladder cancer and brain cancer. Nearly 5,500 patients participated in clinical trials testing the experimental drug, and the results were alarming. At the end of the two-year study, doctors diagnosed nine dapagliflozin users with breast cancer and another nine with bladder cancer. At least one serious liver injury was also reported.

Federal regulators are concerned that the benefits of dapagliflozin, which include lower blood sugar and weight loss, do not outweigh the serious health risks. An FDA advisory committee met on July 19, 2011, and a final approval decision is expected in October of 2011. Bladder and breast cancer are the most serious health concerns, but other safety problems also exist that may prevent the drug from reaching the market. The new experimental diabetes drug is not as effective on patients with impaired kidney functions, and it also increases the risk of urinary and genital infections. Serious side effects like these have led to a number of drug injury lawsuits for similar diabetes drugs. When a drug injury occurs, designers, manufacturers, and others involved in the distribution chain can be liable for the defective drug product.

Actos is one of the most popular and controversial diabetes drugs on the market, and is so dangerous that it was recalled in Germany and France. The FDA recently issued a new bladder cancer warning for Actos users, but the drug is still widely sold in the United States.

With approximately 25 million people around the world suffering from diabetes, the risk of exposure to diabetes drug-related health problems is significant. When injuries result from a defective drug product, several parties on the distribution chain face liability. Defective drug litigation sends a clear message to pharmaceutical companies that they need to take accountability and avoid injuring innocent consumers. Whether or not dapagliflozin is ultimately approved remains to be seen, but there are still several dangerous diabetes drugs on the market that could cause serious harm.