Byetta is an injectable therapy to improve blood sugar control in patients with Type II diabetes.
Since this page was originally written in 2009, a bigger problem arose with Byetta: pancreatic cancer. You can read about these cases here.
Byetta is most often prescribed for patients who have not been able to achieve adequate control on metformin and/or a sulfonylurea, two often prescribed diabetes medications that are taken orally. Byetta has been prescribed alone or in conjunction with other diabetes medicines. There have been over 6.6 million prescriptions of Byetta in the three and-a-half years since it was approved by the FDA. It is manufactured by Amylin Pharmaceuticals, Inc. and Eli Lilly and Company.
Byetta (pronounced bye-A-tuh), the trade name for exenatide, is the first in a new class of medicines known as incretin mimetics. The idea behind Byetta is that it improves a diabetes patient's blood sugar by lowering both post-meal and fasting glucose levels. If effective, Byetta leads to better long-term control of the condition (as measured by hemoglobin A1C).Why Is The FDA Warning Patients About Byetta?
The FDA has received post-marketing reports (complaints from patients and doctors after a drug is released to the public) that some patients have developed serious, life-threatening injuries while taking Byetta. In the three and-a-half years since Byetta’s release, the FDA has been notified of 78 patients with “altered kidney function.” Here is the breakdown, according to a November 2, 2009 FDA alert to healthcare professionals:
- 62 patients with acute renal failure (sudden and severe loss of kidney function)
- 16 patients with renal insufficiency (decreased ability of kidneys to remove waste from the body)
These problems occurred as soon as 3 days after taking Byetta, and as long as 2 years after starting a regimen of Byetta. 91% of the patients required hospitalization. Of the patients who reported problems after taking Byetta, four died, eighteen required dialysis, and two had subsequent kidney transplants. In some cases the injured patients had pre-existing kidney disease, but some patients had no prior history of kidney problems.
The FDA’s Byetta warnings come on the heels of a March 2009 warning by the United Kingdom about kidney injuries following the use of Byetta. The U.K. warned that Byetta should not be used by patients with end-stage renal disease or severe renal impairment.
Acute renal failure and renal insufficiency may cause the following symptoms and side effects:
- Changes in urination (color, frequency, amount)
- Unexplained swelling in the extremities
- Increased blood pressure
- Changes in appetite
- Aching in lower or mid-back.
What Does The Manufacturer Say About The Kidney Dangers Of Byetta?
Amylin and Lilly issued a “Dear Doctor” warning letter to healthcare physicians in October, 2009. In this letter, the manufacturer noted that acute renal failure was added to the Bytetta prescribing information as postmarket adverse events. In the letter, they gave the following warning:
BYETTA should not be used in patients with severe renal impairment (creatinine clearance < 30 mL/min) or end-stage renal disease, and should be used with caution in patients with renal transplantation [see Use in Specific Populations (8.6)]. In patients with end-stage renal disease receiving dialysis, single doses of BYETTA 5 mcg were not well-tolerated due to gastrointestinal side effects. Because BYETTA may induce nausea and vomiting with transient hypovolemia, treatment may worsen renal function. Caution should be applied when initiating or escalating doses of BYETTA from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 mL/min).
The manufacturers of Byetta are clearly aware of the potential for harm created by their drug. Now, it is their obligation to adequately warn doctors and prescribers in order to prevent more injury.What To Do If You Have a Kidney Injury from the Use of Byetta?
Our attorneys have been monitoring potential Byetta cases since October 2008, when the first reports came out about the association between Byetta and various side effects, including pancreatic injuries (LINK). Our lawyers believe now is the appropriate time to begin a potential review of kidney-related Byetta injuries.
Accordingly, Our Byetta recall lawyers are reviewing these Byetta kidney cases throughout the country. Though these cases will not likely be class action lawsuits, it is possible that cases may at some point be combined into MultiDistrict Litigation. If you want to discuss your case with one of our lawyers call us at 800-553-8082 for a free consultation or click here for a free Internet consultation on your potential claim.
- Byetta Lawyers for Pancreas Injuries
- October 2007 Dear Doctor Letter from Amylin and Lilly
- January 2008 Byetta Label
- 08/18/08 FDA Press Release concerning Byetta and Pancreas Injuries (Byetta FDA Safety Information (08-18-08))
- 11/02/09 FDA Press Release concerning Byetta and Kidney Injuries
- 11/02/09 FDA Information for Healthcare Providers concerning Byetta and Kidney Injuries