Byetta - post marketing research has found problems with it

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Byetta is gotten from the saliva of the gila monster which is a scary looking lizard. It has been shown to not only reduce blood sugar levels but also cause loss of appetite in some folks which could result in weight loss, a comodity most Americans feel is very nice.

Byetta is something you might not want to take... besides being an injected medication, post marketing research uncovered a risk of pancreatitis and in November 2009, an FDA warning was issued about a connection between Byetta and kidney failure / dysfunction.  Here is the notice:

Byetta (exenatide) - Renal Failure

Audience: Endocrine and nephrology healthcare professionals

FDA notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. Byetta, an incretin-mimetic, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

From April 2005 through October 2008, FDA received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. Labeling changes include:

  • Information regarding post-market reports of acute renal failure and insufficiency, highlighting that Byetta should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease.
  • Recommendations to healthcare professionals that caution should be applied when initiating or increasing doses of Byetta from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min).
  • Recommendations that healthcare professionals monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need for Byetta if kidney dysfunction is suspected while using the product.
  • Information about kidney dysfunction in the patient Medication Guide to help patients understand the benefits and potential risks associated with Byetta.

Read the complete MedWatch 2009 safety summary, including a link to the Healthcare Professional information sheet, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188703.htm

 

Many highly risky medications have not been recalled but there are those who have advocated recall of Byetta in December 2008: http://www.usrecallnews.com/2008/12/byetta-recall.html

Other side effects associated with Byetta are:

  • Nausea
  • digestive problems
    • GERD (byetta slows gastric emptying)
    • abdominal distention and pain
    • diarrhea
    • belching
  • conflicting with other medications
    • tylenol
    • statin drugs (for lowering cholesterol)
  • vomiting
  • hypoglycemia

Seems the safest medication for diabetes is still metformin (and glyposide)

More technical informational on Byetta  (PDF -requires adobe reader)