What Is Byetta? When Is It Prescribed?
Byetta is a brand name for the drug exenatide. Amylin Pharmaceuticals developed the drug, which it produces and sells with Eli Lilly and Company. It is a medication for treating Type 2 diabetes, often prescribed in conjunction with other anti-diabetic drugs such as metformin, sulfonylureas, and thiazolidinediones. The U.S. Food and Drug Administration (FDA) approved exenatide in April 2005.
Both pharmaceutical companies sell Byetta in multiple strengths ranging from 300mcg/1.2mL to 600mcg/2.4mL. Users inject Byetta beneath the skin into the abdomen, arm, or thigh twice daily up to an hour before breakfast and dinner. From April 2005 to October 2008, doctors prescribed the drug 7,000,000 times. In August 2008, Byetta prescriptions held at 250,000 per month.
Exenatide’s origin differs from those of contemporary laboratory drugs. It is based on a hormone, exendin-4, discovered in Gila monster saliva in 1992. Scientists found that exenatide functions in the same manner as a glucagon-like peptide-1 (GLP-1). GLP-1s promote insulin secretion in the pancreas and glucose metabolization. Exenatide helps Type 2 diabetics because it relieves insulin deficiencies while preventing sugar over-production. Unlike anti-diabetic drugs such as synthetic insulin injections, exenatide users do not suffer from excess insulin, which causes reduced blood sugar (or a worse condition, hypoglycemia).
By 2008, Amylin Pharmaceuticals had earned $700 million in Byetta sales. Since then multiple controversies have affected confidence in the drug. The FDA began issuing Byetta warnings in 2007, though it has not yet required a “black box warning,” the agency’s most serious alert, on Byetta’s packaging. Few people advocate for a Byetta recall even though Byetta has been associated with several fatalities.
Byetta Might Cause Life-Threatening Side Effects
In October 2007, the FDA issued a warning via Byetta’s packaging that the drug causes pancreatic complications in users, a potentially fatal circumstance. In 2010, the FDA began questioning whether Byetta use causes thyroid cancer.
The FDA has disclosed that it received 30 reports from Byetta users documenting that the drug caused acute pancreatitis, an inflammation of the pancreas. Byetta can cause infection, tissue damage, hemorrhaging, and cellular necrosis. If the pancreas hemorrhages, the released fluids can damage nearby internal organs. Acute pancreatitis can also be fatal. Of the 30 patients who submitted reports, 5 had suffered kidney failure. Others endured worse symptoms when their Byetta dosages increased. Most of the 30 patients’ symptoms eased after they ceased using Byetta.
Not even a year later, in August 2008, the FDA issued a second Byetta warning. This time, it disclosed that four Byetta users had died of pancreatitis, while four others had been hospitalized for hemorrhaging and necrotizing of the pancreas. Similarly, in November of 2009, the FDA disclosed that it had received 78 reports of kidney problems in Byetta users.
Finally, in April 2010, an FDA memo, dated the previous January, surfaced. The memo considered the correlation between Byetta use and thyroid cancer. Eli Lilly admitted that its researchers had found a similar correlation in tests on rats but insisted that thyroid cancer only occurred in exenatide doses 25 times that found in Byetta. The FDA has not issued a new Byetta warning, or a recall, but it did ask both Eli Lilly and Amylin to further research the connection.
In July 2011, researchers at the University of California, Los Angeles studied the connection between Byetta and pancreatic cancer, pancreatitis, and thyroid cancer by combing FDA adverse events reports. They calculated a sixfold increase in users developing pancreatitis, and Byetta increased the likelihood of pancreatic cancer by 2.9 times. The lead researcher, Dr. Peter Butler, cautioned that the results do not account for increased Byetta side effects reporting by doctors. The study appeared in the journal Gastroentereology.
On March 14, 2013, the FDA issued a drug safety communication informing the public that it is evaluating unpublished findings by researchers indicating that connected Byetta with pancreatitis and cellular changes called “pancreatic duct metaplasia.” The agency is requesting the researchers provide it with their research methodology and tissue samples they used.
In late July 2013, the U.S. Judicial Panel on Multidistrict Litigation (JPML) heard arguments by Byetta users who were suing Amylin and Eli Lilly, as well as from users of similar incretin mimetic drugs, to consolidate their cases into a multidistrict litigation (MDL). The JPML was hesitant to merge cases brought against multiple manufacturers, but it determined that there were sufficient common issues of fact and law to make the consolidation worthwhile. The JPML transferred the MDL to the U.S. District Court for the Southern District of California before Judge Anthony J. Battaglia. It is captioned In re: Incretin-Based Therapies Products Liability Litigation (MDL – 2452).
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers of the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Byetta lawsuit on your behalf if necessary.
If you’ve taken Byetta and believe it harmed you, contact RLG today for a free, confidential legal consultation.