That Health Rules

This is just an information sheet to those who are on Byetta as part of the treatment regimen for Diabetes.  Any new drug in the market has post marketing survey done to determine any untoward events once a drug is marketed and used worldwide.  After its approval in 2005, it has just been available in the Philippines this year.

Byetta is known to cause nausea due to its effect in delaying gastric emptying.  This symptom usually goes away after weeks to months of use.  However if abdominal pain occurs and becomes persitsent… it is now advised to discontinue the drug and seek medical advise to rule out pancreatitis.

Acute Pancreatitis is inflammation of the pancreas and ussually is due to either alcohol intake or gallstone.  Once diagnosed and treated it is not life threatening.  Majority of the cases in the survey did well after trteatment of the disease.

The FDA has issued an alert to physicains to be aware of this effect:

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Posted 10/16/2007] FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta (exenatide), a drug used to treat adults with type 2 diabetes.

An association between Byetta and acute pancreatitis is suspected in some of these cases. Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label.

Healthcare professionals should be alert to the signs and symptoms of acute pancreatitis and instruct patients taking Byetta to seek prompt medical care if they experience unexplained, persistent, severe abdominal pain which may or may not be accompanied by vomiting. If pancreatitis is suspected, Byetta should be discontinued. If pancreatitis is confirmed, Byetta should not be restarted unless an alternative etiology is identified.
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Byetta is one new drug that will be very beneficial to our newly diagnosed diabetes especially those who are obese because of its capacity ot improve insulin sensitivty and increase beta cell mass.  Preventing the rapid decline of beta cell mass and function therefore theoritically should prevent progression of this disease and in turn prevent the onset of complications. 

The PLUS factor of thes agent: It can lead to significant weight loss and is the only agent so far that can really make a diabetic well controlled without necesarily increasing weight but rather lose weight!

For now with this new alert, I would have to make sure patients with history of pancreatitis, alcohol abuse or gallstone to refrain from using Byetta.   The data showed that those who developed Pancreatitis had at least 1 of the above risk factors.  Vigilance of these factors should lessen one’s risk to develop pancreatitis.

Just Like Any Drug… If It Has An Effect… It Should Have A Side Effect..Precaution Is The KEY!