Laman ini diujudkan buat anda yang mencari kaedah ubatan herba alam semulajadi untuk sakit barah, selain berkongsi pendapat dan pengalaman sesama ahli. Menyedari faktor penyebab barah selain mengelak penipuan kerana pesakit barah selalu ditipu oleh orang yang rakus mengaut untung semata-mata. Laman ini juga bertujuan menyingkap amalan buruk yang merugikan kita.
The Food and Drug Administration (FDA) is looking into findings published by a group of
researchers suggesting diabetes drugs have a link to pancreatic cancer.
The FDA said it is reviewing unpublished findings that suggest
pre-cancerous cellular changes could be associated with specific Type 2
diabetes drugs known as incretin mimetics. These findings were based on
examination of a small number of pancreatic tissue specimens taken from
patients after they died from unspecific causes.
The agency said it asked the researchers to
provide the methodology to collect and study these specimens and to provide the
tissue samples so it can further investigate potential pancreatic toxicity
associated with the drug.
Drugs in the incretin mimetic class work by
mimicking the incretin hormones that the body produces naturally to stimulate
the release of insulin in response to a meal. These drugs are used along with
diet and exercise to lower blood sugar in adults with Type 2 diabetes.
“This early communication is intended only to
inform the public and health care professionals that the Agency intends to
obtain and evaluate this new information,” the agency said in a statement.
“FDA will communicate its final conclusions and recommendations when its review
is complete or when the Agency has additional information to report.”
Questions about the drug and its effects on the pancreas have been
raised before, and the drug’s label even contains warnings about the risk
of acute pancreatitis. However, researchers at the American Diabetes
Association’s (ADA) 69th Scientific Sessions in 2009 concluded that incretin
mimetics did not increase the risk of pancreatitis in patients with diabetes.
In February, John Hopkins
researchers wrote in JAMA
Internal Medicine contradicting the findings in 2009, saying the
drugs are associated with an increased risk of hospitalization for acute pancreatitis. They said agents in drugs under the brand
names Januvia and Byetta contribute to the formation of lesions in the pancreas
and the proliferation of ducts in the organ.
“These agents are used by millions of
Americans with diabetes. These new diabetes drugs are very effective in
lowering blood glucose. However, important safety findings may not have been
fully explored and some side effects such as acute pancreatitis don’t appear
until widespread use after approval,” says study leader Sonal Singh, M.D.,
M.P.H., an assistant professor in the Division of General Internal Medicine at
the Johns Hopkins University School of Medicine.
The FDA ensured that patients should still be
taking their medicine as directed until they talk to their healthcare
professional. Also, health care professionals should be following the
prescribing recommendations for drug labels.
People taking diabetes drugs such as Merck & Co. (MRK)’s
Januvia were affected by pancreatic cell growth and damage that may turn
cancerous, a small study found.
The study, led by Alexandra Butler and Peter
Butler of the University
of California, Los
Angeles, provides evidence of increased pre-cancerous changes in diabetic
patients using so- called incretin mimetics, Public Citizen, a Washington-based
public advocacy group, said in a statement today after the research was
“These findings are in accord with the
rapidly increasing number of reports to the U.S Food and Drug
Administration of pancreatic cancer in patients using these drugs compared
with diabetics using other drugs,” Public Citizen said.
Doctors have been concerned that this
category of diabetes treatments may damage the pancreas since the FDA said in
2007 it received a high number of reports of pancreatitis in patients taking
Byetta. The agency issued a similar alert for Januvia in 2009. An analysis of
insurance records published last month in the journal JAMA Internal Medicine
showed such drugs may double a user’s risk of pancreatitis. That hasn’t stopped
these medicines from becoming multibillion-dollar drugs.
Merck shares rose
less than 1 percent to $43.90 at 4 p.m. New York time. Bristol-Myers
rose 1.7 percent to $40.39. Novo Nordisk fell 1 percent to 927.50 Danish
An examination of pancreases from 20
diabetics showed a 40 percent increase in pancreatic cells as well as cell
damage in the people treated with incretin therapy, today’s study found. Of the
20 pancreases, eight were from people taking incretin therapy, while 12 were on
other treatment, according to a study in Diabetes,
a journal of the American
Diabetes Association. Seven of the eight patients taking incretin therapies
for a year or more were using Merck’s Januvia while the other was using Byetta,
according to the study.
The research showed that in humans, incretin
therapy resulted in “marked” cell proliferation and damage, with a potential
for evolution into cancer, the authors wrote.
Merck disagrees with the study’s hypothesis,
is confident in the safety of its drug and hasn’t seen any causal link between
it and pancreatitis or pancreatic cancer, Kelley Dougherty, a spokeswoman for
Station, New Jersey- based drugmaker, said in a statement.
“We would remind you that the FDA said last
week that the FDA has not reached any new conclusions about safety risks with
these medicines, and at this time patients should continue to take their
medicine as directed until they talk to their health care provider, and health
care providers should continue to follow the prescribing information in the
drug labels,” Dougherty said.
about $4.1 billion in 2012 worldwide sales, Merck has reported.
Ken Dominski, a spokesman for New York-based
Bristol-Myers, declined to comment on the study’s findings.
As for Byetta, known as exenatide, “an
extensive nonclinical safety program was conducted to support the marketing
applications of exenatide twice daily and exenatide once weekly,” Dominski said
in an e-mail. “In those studies, exenatide administration was not associated
with any drug- related pancreatic tissue damage or toxicity in any species
Byetta and its longer-acting version,
Bydureon, had $227 million in 2012 sales,
Victoza, also known as liraglutide, is the fastest-growing product for Bagsvaerd, Denmark-based
Novo, with sales jumping 58 percent in 2012 to 9.5 billion kroner ($1.7
billion). The medicine mimics a hormone called GLP-1 to stimulate natural
A Novo spokeswoman declined to comment on the
study published today.