TUESDAY Sep. 9, 2008 (foodconsumer.org) -- Amylin
Pharmaceuticals today released a new study at the European Association for the
Study of Diabetes in Rome to demonstrate that its anti-diabetes drug Byetta is
better than Januvia, a diabetes drug made by Merck, news media reported.
Amylin and Eli Lilly confirmed that Byetta is indeed more
potent than Januvia.
But Merck Co. Inc.
said comparing Byetta to Januvia is like comparing apples to oranges.
Januvia, used once a day, is indicated for patients who
experience the earlier signs of type 2 diabetes while Byetta, injected twice a
day is prescribed for patients with advanced type 2 diabetes who need
additional benefits such as weight loss and suppressed appetite, according to
Dr. Barry Goldstein, Merck's vice president of clinical
research, told Forbes.com that the Amylin study did not compare the side
effects of the two drugs.
In fact, the
Merck diabetes drug Januvia has less severe adverse effects.
One severe adverse effect associated with both drugs is
increased risk of pancreatitis.
Werber of Citi Investment Research was cited as saying in a client note that
patients on Byetta are four times as likely to develop pancreatitis as those on
Werber said of every 100,000 patients on Byetta, 6.5 are
expected to develop acute pancreatitis compared to 1.6 for every 100,000
patients taking Januvia.
(Editor's note: the severity of diabetes in the two
groups may be different and the data may not mean that the higher incidence of
pancreatitis in patients on Byetta is due to the drug itself. In any case, a
causal relationship has not bee established.)
There is more bad news for Byetta.
Food and Drug Administration announced last month that six patients who had
been taking Byetta developed severe pancreatitis of whom two had died.
Pancretistis, which can release toxins contaminating the
bloodstream, can develop in patients with diabetes.
It is obviously unknown whether the increased
risk was due to the effect of the drug or the patients’ condition.
"The study is really looking at the peak of when
Byetta is in the body after it is injected; on the other hand, Januvia works
for a 24-hour period and has a steady effect," Goldstein was quoted as
saying. "It's a mismatch in comparing the two in the way that the study is
Byetta being taken by an estimated 700,000 Americans was
expected to be considered for approval in early 2009, according to Werber,
cited by forbes.com.
The following is the message issued by the FDA regarding
the safety of Byetta.
Audience: Endocrinologists, other healthcare professionals, consumers [UPDATED 08/18/2008] Since issuing
Information for Healthcare Professionals in October 2007, FDA has received
reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients
taking Byetta. Byetta is a medicine given by subcutaneous injection to help
treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing
pancreatitis, all patients required hospitalization, two patients died and four
patients were recovering at time of reporting. Byetta was discontinued in all 6
cases. Byetta and other potentially suspect drugs should be promptly
discontinued if pancreatitis is suspected. There are no signs or symptoms that
distinguish acute hemorrhagic or necrotizing pancreatitis associated with
Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed,
initiate appropriate treatment and carefully monitor the patient until
recovery. Byetta should not be restarted. Consider antidiabetic therapies other
than Byetta in patients with a history of pancreatitis.
[UPDATED 02/27/2008] Dear Healthcare Professional letter posted.
[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
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.
Update 8/18/2008: Since issuing Information for Healthcare Professionals
in October 2007, FDA has received reports of 6 cases of hemorrhagic or
necrotizing pancreatitis in patients taking Byetta. Byetta is a
medicine given by subcutaneous injection to help treat adults with type
2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis,
all patients required hospitalization, two patients died and four
patients were recovering at time of reporting. Byetta was discontinued
in all 6 cases.
Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There
are no known patient characteristics which determine when pancreatitis
associated with Byetta will be complicated by the hemorrhagic or
necrotizing forms of this condition. If pancreatitis is confirmed,
initiate appropriate treatment and carefully monitor the patient until
recovery. Byetta should not be restarted. Consider antidiabetic
therapies other than Byetta in patients with a history of pancreatitis.
FDA is working with the maker of Byetta, Amylin
Pharmaceuticals, Inc., to add stronger and more prominent warnings in
the product label about the risk of acute hemorrhagic or necrotizing
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.
report any unexpected adverse or serious events associated with the use
of this drug, please contact the FDA MedWatch program and complete a
form on line at http://www.fda.gov/medwatch/report/hcp.htm
or report by fax to 1-800-FDA-0178, by mail using the postage-paid
address form provided on line, or by telephone to 1-800-FDA-1088.
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