Diabetes Drug Shows “Unexpected” Safety Issues
By Kristen Askin
Published July 15, 2011
The Food and Drug Administration announced Friday that a new diabetes drug being developed by Bristol-Myers Squibb Co. (BMY) and AstraZeneca PLC (AZN) is effective in lowering patients’ blood sugar level, but also presents several “unexpected” safety concerns.
In a report posted on its website, the FDA said the drug, dapagliflozin, could possibly be related to breast and bladder cancer. Safety data released last month reveal that nine bladder cancer cases were found in 5,478 patients treated with dapagliflozin, compared with one case out of 3,156 untreated patients, while nine breast cancers were reported in 2,223 users of the drug, compared with one among 1,053 non-users.
The implications of the results are still unclear, as most of the cancers were reported in the first year of the study, and cancer typically takes time to develop.
The agency also said the drug may have decreased effectiveness in patients with kidney impairment, and could present users with a greater chance of liver injury, genital infections and urinary tract infections.
In studies comparing dapagliflozin with other diabetes drugs, the new drug was more effective at lowering blood sugar levels in patients than other treatments for the disease that affects nearly 26 million Americans.
The FDA’s panel will meet on July 19th to discuss the studies and vote on a recommendation for the approval of dapagliflozin.