Byetta is a short-acting form of exenatide which is used to treat Type 2 diabetes. It is an injectable that helps to control blood sugar by helping the pancreas to produce insulin more efficiently. Byetta is in a class of drugs known as incretin mimetics and lowers blood glucose levels by stimulating insulin secretion in the pancreas. Byetta was approved by the FDA in 2005 and had been prescribed more than 7 million times by 2008.

In 2007, the FDA warned the healthcare community about a possible link between Byetta and pancreatitis—which can be fatal in some patients. The FDA had received reports of 30 cases of pancreatitis, and the manufacturer was asked to place a warning on the drugs’ packaging.

Not long after, in 2008, a second alert was issued after Byetta was once again linked to a dangerous side effect. This time, the FDA had reports of six different cases of necrotizing pancreatitis or hemorrhaging pancreatitis. At least two of these cases turned out to be fatal. Hemorrhaging pancreatitis occurs when there is massive erosion of blood vessels that could lead to severe bleeding.

The FDA announced in 2009 that new information would be added to Byetta prescriptions. After the drug had been linked to serious side effects such as pancreatitis and kidney failure, the FDA wanted to warn doctors and patients of the potential for damage. When this occurred, the FDA had reports of 78 patients who had experienced kidney function issues, while they found 62 reports of kidney failure.

Byetta is known to cause nausea and vomiting in patients, and doctors suspect that these side effects might be what has caused some of the kidney problems. Altered kidney function can be very serious if it is not treated. Lack of kidney function can lead to waste build-up in the bloodstream which can result in serious injury or death.

The FDA has now suggested that healthcare professionals monitor patients taking Byetta very carefully and to discontinue use of the drug if pancreatitis is suspected. Pancreatitis is many times a precursor to pancreatic cancer—one of the most deadly forms of the disease.

Serious Side Effects Include:

  • Swelling, weight gain, feeling short of breath, urinating less than usual or not at all
  • Drowsiness, confusion, mood changes, increased thirst, diarrhea
  • Dull pain in your middle or lower back
  • Severe pain in your upper stomach spreading to your back, vomiting
  • Low blood sugar (headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery)

Other Side Effects Include:

  • Nausea, upset stomach, diarrhea or constipation
  • Weight loss
  • Loss of appetite
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