| October
17, 2007
FDA Warns of Potential Link Between Byetta
and Pancreatitis
Yael Waknine
October 17, 2007 — Use of exenatide (Byetta, Amylin Pharmaceuticals,
Inc) may be linked to a risk for pancreatitis, the US Food and
Drug Administration warned healthcare professionals yesterday.
The warning was based on data from 30 postmarketing reports of
acute pancreatitis in exenatide-treated patients, according to
an alert sent from MedWatch, the FDA's safety information and
adverse event reporting program.
Most of the patients had at least 1 additional risk factor for
the condition, such as gallstones, severe hypertriglyceridemia,
and alcohol use. Less often (7 cases), the advent of pancreatitis
symptoms corresponded with increases in twice-daily dosing from
5 to 10 µg.
Of 21 patients requiring hospitalization, 5 developed serious
complications that included dehydration and renal failure, suspected
ileus, phlegmon, and ascites. No cases of hemorrhagic or necrotizing
pancreatitis were reported.
Although the role of exenatide remains unclear, 22 patients (73%)
improved after discontinuation of therapy. Details from 3 reports
showed that symptoms of pancreatitis returned with resumption
of therapy — 2 patients experienced nausea and vomiting,
and a third developed abdominal pain that abated upon permanent
discontinuation of exenatide.
Healthcare professionals are advised to remain alert for signs
and symptoms of acute pancreatitis and to instruct patients to
seek prompt medical care for unexplained, persistent abdominal
pain with or without vomiting.
Treatment with exenatide should be discontinued if pancreatitis
is suspected and permanently discontinued upon diagnostic confirmation
(elevated serum amylase and/or lipase levels and radiologic imaging)
unless another etiology is identified.
Exenatide is indicated as adjunctive therapy to improve glycemic
control in patients with type 2 diabetes mellitus who have not
achieved adequate control with metformin, a sulfonylurea, a thiazolidinedione,
or a combination of these.
Healthcare professionals are encouraged to exenatide-related
adverse events to the FDA's MedWatch reporting program by phone
at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch,
or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
Source: www.medscape.com
Comments:
Exenatide (Byetta) is new type of anti-diabetic medication
that is indicated as adjunct therapy to improve blood sugar
control in patients with type 2 diabetes mellitus who have
not achieved adequate control with other medications like
metformin, a sulfonylurea, a thiazolidinedione, or a combination
of these. Based on data from 30 post-marketing reports of
acute pancreatitis in exenatide-treated patients, the FDA
is now warning doctors that patients on Byetta can have
this adverse event of pancreatitis.
There are a large number of medications to treat type
2 diabetes that give many side effects, however new medications
continue to be approved without conducting any studies showing
safety and health benefits of these drugs over "older"
medications. This is because of the pharmaceutical industry's
pressure on the FDA to expedite approval of new drugs for
profit, not for the health of millions of patients. In chronic
disease like diabetes, the role of specific synergistic
cellular nutrients in regulating blood sugar level, HbA1C
hemoglobin that is a marker of the damage to cell structures
caused by elevated sugar levels and the long-term indicator
for diabetes and preventing diabetic complications is critical,
as it has been proven by Dr.Rath's research and clinical
study. Please read more about Dr.Rath's research in diabetes
at www4.dr-rath-foundation.org
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