Diabetes Drug Prescribing Information Revised to Reflect Reports of Kidney Problems

By November 6, 2009Dangerous Drugs

As a pharmaceutical liability attorney, I have noticed several reports of serious safety problems with the newest drugs intended for treatment of Type II diabetes. So I was disappointed, but not entirely surprised, to see a safety alert issued by the Food and Drug Administration Nov. 2 about problems with the diabetes drug Byetta (exenatide). According to a report from U.S. News and World Report, the FDA received 78 reports of kidney function problems in 4.5 years from people taking Byetta. In response, the agency announced major labeling changes for Byetta, including the addition of information on the kidney risks as well as advice to physicians to monitor patients for kidney problems.
Byetta, made by Amylin Pharmaceuticals Inc. of San Diego, is used to control blood sugar levels in Type II diabetes patients already using diet, exercise and some other diabetes medications. The FDA said its reports of problems with Byetta included 62 cases of acute kidney failure as well as 16 cases of renal insufficiency. Some, but not all, of the cases were in patients who already had kidney problems or were at risk for kidney problems. In addition to adding information on those cases to the label, the FDA said it would add information on kidney dysfunction to the prescription information for Byetta, so that patients can identify problems more quickly. It also asked health care professionals not to use the drug in patients with severe kidney problems and to use caution with patients with moderate kidney problems.
This is the second post-marketing report of serious side effects for Byetta. In 2007, the FDA issued a safety alert after receiving reports of acute pancreatitis in patients taking the drug. In 2008, the agency received at least four reports of death from pancreatitis, a sudden and painful inflammation of the pancreas. It can also reduce blood sugar to dangerously low levels (hypoglycemia).
As a dangerous drug lawyer, I am pleased to see the FDA take reasonably quick action on these reports of kidney problems. Renal failure is a type of organ failure with very serious implications for the patient. When the kidneys stop working, patients suffer pain and serious illness, as well as high risk of complications like anemia. Severely affected patients must depend on daily dialysis or hope for a transplant in order to stay healthy. And U.S. News and World Report said there were seven million prescriptions for the drug written during the 4.5-year period the FDA examined, which means millions of Americans are likely exposed to this side effect. When the risk is this serious, patients and their doctors have the right to know as much as possible about it.


Unfortunately, the FDA’s warning may come too late for patients who have already suffered kidney damage that can’t be reversed. For these patients, the best option may be a lawsuit that holds Byetta’s manufacturer responsible. Even when the manufacturer didn’t intend serious safety defects in a drug or didn’t actively attempt to hide it, victims may still hold it legally and financially liable for the results of its drug’s defects. At the Lowe Law Firm, our defective medication attorneys help victims claim compensation for all of their injuries, including the devastating physical and emotional effects of a dangerous drug as well as the steep financial cost of treatment.
If you or a loved one has been injured by Byetta or another drug with serious safety problems, the Lowe Law Firm can help. To learn more at a free, confidential consultation, please contact us through our Web site or call 1-877-678-3400 today.