Archive for October, 2007

iPump.org, Inc. Responds to Diabetics Affected by Southern California Wild Fires
iPump.org, Inc. Press Release:  October 22, 2007             .pdf Press Release

For Immediate Release

For the past year, iPump.org, Inc. has provided assistance to many (diabetic) victims of Hurricane Katrina. Now, they move quickly to help diabetics in their own state during a time of crisis. A new program called Cal-DSERT (California Diabetes State of Emergency Relief Trust) will benefit families who have diabetes and lost their home, business, or job due to the 2007 California wild fires. October 22, 2007.

iPump.org, Inc., an all-volunteer run nonprofit public charity, has been assisting diabetic patients in need since 2006.  Its founder, and volunteer CEO, Lahle Wolfe has diabetes as do two of her children.  She understands that diabetes is a disorder that requires constant medical attention in order to live. According to Wolfe, ”To even go one day without test strips, syringes, or insulin, could cost a type 1 diabetic their life.”

iPump is based on Southern California where the fires began. As Wolfe and her children watched distant smoke plumes from their own backyard, ashes rained down like snowflakes on her youngest daughter, Elizabeth, age 8 who has type 1 diabetes. Wolfe recounts, “She turned and asked if people had time to get their pets and diabetes “stuff” and all I could reply was that I hoped so.”

Wolfe immediately began hashing out guidelines for yet another unique program called the California Diabetes State of Emergency Relief Trust (Cal-DSERT) and by the end of the work day a new assistance program was in place. Cal-DSERT is different from other iPump programs because it will only serve victims of the California fires of 2007.  Wolfe believes that those who have lost their home, business, or job in the fires will need more time and assistance to get them back on solid ground. “We hope donors will give generously to this program so that can provide longer term assistance than our other programs can.  We are still helping diabetic victims of Hurricane Katrina, who, after all this time still have limited resources available for assistance.”

For qualifying diabetics who have lost their home, business, or job because of the fires iPump may be able to send financial assistance as well as purchase insulin, medications, and diabetes supplies directly for those in need if we do not have a supply on-hand to give away for free.  To make this program work,iPump is requesting both financial donations as well as donations of unexpired diabetes supplies.

To make a donation, visit their website at www.ipump.org or send supply donations and checks made payable to iPump.org, to:  IPump.org, Inc, 2250 Alyssum Avenue, Upland, CA 91784.  Be sure to earmark your donation for “Cal-DSERT” or “Fire Fund.”  If you include your contact information iPump will send you a tax receipt.

Email Lahle Wolfe if you would like more information about iPump.org, Inc. or any of its programs, or have questions about making donations.

October 16, 2007

For those who may be using BYETTA (which may be prescribed for PCOS, pre-diabetes, type 2, or LADA) the FDA has issued warnings about patients using BYETTA developing pancreatitis.

Read more on WebMD

Exenatide (marketed as Byetta)

FDA ALERT [10/2007]:  FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta, a drug used to treat adults with type 2 diabetes.  An association between Byetta and acute pancreatitis is suspected in some of these cases.

Healthcare professionals should 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.

FDA has asked and the maker of Byetta, Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label.

This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA is not advising practitioners to discontinue prescribing the product.  FDA intends to update this sheet when additional information or analyses become available.

The Byetta full prescribing information will include new information in the PRECAUTIONS section about the potential for acute pancreatitis in patients taking Byetta.

Recommendations and Considerations

• Healthcare providers should be alert to the signs and symptoms of acute pancreatitis. Symptoms include persistent severe abdominal pain that can radiate to the back and may be accompanied by nausea and vomiting.  Acute pancreatitis is typically confirmed by the presence of elevated levels of serum amylase and/or lipase and characteristic findings by radiological imaging.

• Discontinue Byetta if pancreatitis is suspected. If pancreatitis is confirmed, do not restart Byetta unless an alternative etiology for the pancreatitis is identified.

Information for the patient: Physicians who prescribe Byetta should discuss with their patients:

Byetta is a medicine given by injection to help treat adults with type 2 diabetes.  Commonly reported side effects of Byetta include nausea, vomiting, diarrhea, indigestion and upper abdominal discomfort.  However, the presence of unexplained, severe abdominal pain, with or without nausea and vomiting, raises the suspicion of acute pancreatitis, a potentially serious condition that requires prompt medical attention. Therefore, patients taking Byetta should promptly seek medical care if they experience unexplained severe abdominal pain with or without nausea and vomiting.

Background Information and Data

FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients treated with Byetta.  Twenty-seven of the 30 patients had at least one other risk factor for acute pancreatitis such as gallstones, severe hypertriglyceridemia, and alcohol use.  In six patients the symptoms of pancreatitis began or worsened soon after the dose of Byetta was increased from 5 micrograms twice daily to 10 micrograms twice daily.  Twenty-one patients were hospitalized.  There were no reports of hemorrhagic or necrotizing pancreatitis.  However, five patients developed serious complications including dehydration and renal failure; suspected ileus; phlegmon; and ascites.  Twenty-two of the 30 reports indicated that the patients improved after discontinuing Byetta.

Details in three reports indicated that the symptoms of acute pancreatitis returned when Byetta was restarted.  Nausea and vomiting returned in two patients when Byetta was restarted.  In a third patient, abdominal pain returned when Byetta was restarted and abated after Byetta was permanently discontinued.

FDA has asked and the maker of Byetta, Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the Precautions section of the product label.

Source: FDA Alerts