A Timeline of FDA Safety Communications Regarding GLP-1 Drugs

October 2007:  The FDA reviewed 30 post-marketing reports of acute pancreatitis in users of Byetta.  The FDA concluded that there was an association between Byetta and acute pancreatitis.  Byetta’s manufacturer Amylin Pharmaceuticals agreed to include information regarding this risk in the precautions section of its label.  The FDA also instructed patients that severe abdominal pain while using this drug should not be ignored.

August 2008:  Since the October 2007 warning, more reports of acute pancreatitis (including necrotizing and hemorrhagic pancreatitis) were made in association with Byetta, some of them fatal.  The FDA warned that doctors and patients should be particularly astute in looking for warning signs.

September 2009:  In this warning, the FDA warned that Januvia (sitagliptin), another GLP-1 drug, may result in acute pancreatitis in some cases.  Doctors should monitor their patients carefully, and be aware of the signs and symptoms of pancreatitis.  If pancreatitis is suspected, Januvia should be discontinued.  Doctors should also inform patients of what symptoms to look for, including nausea, vomiting, and persistent severe abdominal pain.  Patients were also warned to watch for signs, but not to stop taking the medication without informing their doctor.

March 2013:  The FDA begins looking into unpublished studies showing an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasma in type 2 diabetes being treated with incretin mimetics such as Victoza, Byetta, and Januvia.  Previous warnings have been made of pancreatic changes, but not of pre-cancerous changes.

If you have been injured as a result of your diabetes medication, you may be eligible for compensation.  Contact the drug injury attorneys at Kirkendall Dwyer LLP for more information.

Actos and Bladder Cancer

Actos is a treatment for Type 2 diabetes that is in a class of drugs called Thiazolidinediones.  Actos lowers the amount of sugar released by the liver and makes fat cells more sensitive to the effects of insulin.

Avandia, Actos’s sister drug in this same class, became a blockbuster drug before serious heart problems were found to be a side effect of the drug.  After being linked to more than 100,000 heart attacks, and being found to double the risk of heart failure after one year of treatment, the FDA allows only severely restricted use of Avandia.   Avandia’s manufacturer GlaxoSmithKline, has faced serious liability over its one time blockbuster drug.

Initially Actos was thought to be a safe alternative to Avandia, and between January 2010 and October 2010, more than 2.3 million patients filled a prescription for Actos.  But it wasn’t long before it too was linked to serious side effects.  In the case of Actos, the complication is bladder cancer.

Symptoms of bladder cancer may include:

• Red urine or blood in the urine
• Intense urgency to urinate
• Pain while urinating

Actos is manufactured by Takeda Pharmaceuticals, and was marketed in the United States by Eli Lilly.  Lawsuits against both pharmaceutical giants allege that the companies failed to warn patients about the risks associated with Actos use.  Takeda even attempted to fund studies to get FDA approval for Actos to be used in the prediabetic population to prevent diabetes.  With 79 million prediabetic people living in the United States in 2010, this would have been a huge market for the drug company.  Fortunately, the dangers of Actos began coming to light.

If you or a loved one have been injured while taking Actos, we invite you to browse through the information provided on this site.  We are available any time of day to answer any questions you may have about Actos and its side effects, and discuss whether you are an ideal candidate for the ongoing litigation.