Revisions to Byetta's Drug Label

Below is a piece or information just released about the use of Byetta. This does not mean it causes kidney disease but that some care should be taken when kidney disease is present. We have had several people in this category and have not had any problems.

“Dr. Joe” Prendergast



November 3, 2009

Dear Member:

Yesterday, the Food and Drug Administration (FDA) announced that it had approved drug label revisions for Eventide (Byetta), an approved addition to diet and exercise used to improve glycolic control in adults with type 2 diabetes. The drug label is revised to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency.

According to the FDA, from April 2005 through October 2008, the agency received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Eventide. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems.

The FDA has made the following changes to the drug label:

• Information regarding post-market reports of acute renal failure and insufficiency, highlighting that Eventide should not be used in patients with severe renal impairment (creatinine clearance <30>
• Recommendations to healthcare professionals that caution should be applied when initiating or increasing doses of Exenatide 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 Exenatide 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 Exenatide.

Additional information on the revisions to Byetta's drug label, including specific information for physicians and patients, can be found on the FDA website.

Cardiometabolic Risk of Antipsychotic Medications in Youth

Cardiometabolic Risk of Antipsychotic Medications in Youth JAMA Oct 28, 2009 Pg.1765-1773

Many of us, who see people with metabolic syndrome, particularly in young people, have been startled by the sharp rise in new patients who seem to have been started on antipsychotic medication. Many others who are no longer considered “youths” have similar problems.

The Cardiometabolic Syndrome (AKA METABOLIC SYNDROME, DYSMETABOLIC SYNDRONE, and SYNDROME X) is now regarded to be much more of a clinical problem than just prediabetes since the pre-atherosclerotic component is much worse and more dangerous for early death than previously thought.

The weight changes were most striking. 10% to 36% transitioned to overweight or obese within 11 weeks. These changes were not felt to be due worsening psychiatric disorders. The concern is that youths with this weight and metabolic status will accelerate the cardiometabolic syndrome and its complications. The medications involved in this study include,

Risperidone (http://www.medicinenet.com/risperidone/article.htm)

Quetiapine (Seroquel) http://www.seroquelxr.com/index.aspx?source=828&utm_source=google&utm_medium=cpc&utm_content=brandxrdtc&utm_campaign=SQLJUN09&WT.mc_id=SQL0209GOOPSDTCB&gclid=CPSUrs-_650CFRgbawodUgQ6LA

Abilify (Aripiprazole) http://www.abilify.com/

Zyprexa http://www.medicinenet.com/olanzapine/article.htm

To trade a serious psychiatric illness for another serious chronic disease is quite a decision. It is something to seriously think about.

It is looked upon as a drug that can precipitate Diabetes type 2. If you have type 1 you can also add insulin resistance and abdominal fat to your problems.

Dr. Joe