THURSDAY, Sept. 22 (HealthDay News) -- People with type 2
diabetes taking the drugs Januvia or Byetta might have an increased
risk of developing pancreatitis and pancreatic cancer, a
preliminary study suggests.
The study also found that Byetta (exenatide) may raise the risk
of thyroid cancer.
Although the links aren't conclusive, they merit further
investigation, the researchers noted.
"We have raised concern that there may be a link, but we haven't confirmed it," said lead researcher Dr. Peter Butler, director of the Larry L. Hillblom Islet Research Center at the University of California, Los Angeles. "We need to do more work to figure out whether this is real or not."
Both drugs help control blood sugar levels by encouraging
production of a hormone called glucagon-like peptide 1 (GLP-1).
Januvia (sitagliptin) and Byetta, an injectable drug, are a new
way of treating type 2 diabetes, and they potentially have
advantages over older medications, Butler said. But, because these
drugs are new, they're "the ones we know least about," he said.
"When new drugs come out, the long-term side effects of these drugs
are not well understood."
For the study, recently published in the journal
Gastroenterology, Butler's team used 2004-2009 information in the U.S. Food and Drug Administration's database on adverse events, which are reported by doctors whose patients use these drugs.
When compared to other treatments, the researchers found a
sixfold increase of reported cases of pancreatitis (inflammation of
the pancreas) linked to patients taking Januvia or Byetta; a
2.9-fold increase in reported cases of pancreatic cancer among
those taking Byetta and a 2.7-fold increase of reported pancreatic
cancers among Januvia users.
In addition, they also noted an increase in reported cases of
thyroid cancer with Byetta.
This latest study builds on earlier research, published in a
2009 issue of
Diabetes, which found an increase in pancreatitis in rats whose GLP-1 levels were raised, the researchers said.
Butler is quick to point out that these increases in pancreatic
cancer risk, while statistically significant, are not specifically
related to patients, but rather to an increase in doctors reporting
these cases to the FDA.
"It is important to avoid alarmism and have people stop medicines that they may be benefitting from when the risk is not yet defined," he stressed.
"If the drug and you are working well together, I wouldn't say there is any reason to stop the drug, based on the evidence we have right now," he said. "But if you have any concern you should talk to your doctor about it."
Being overweight is an important risk for both pancreatic cancer
and type 2 diabetes, Butler noted. So the first advice to
overweight patients with type 2 diabetes is to lose weight. "By
doing that, you reduce the risk of pancreatic cancer," he said.
In addition, the first medication used to control blood sugar in
type 2 diabetics is metformin, which by itself may reduce the risk
for pancreatic cancer, Butler said. Metformin is an older drug with
a well-known safety profile, he noted.
Dr. Mary Ann Banerji, director of the Diabetes Treatment Center
at SUNY Health Science Center Brooklyn in New York City, said that
"this is not perfect data."
However, Banerji does not prescribe these drugs for patients who
have had a history of pancreatitis or a family history of thyroid
cancer. There are alternatives such as metformin and insulin, as
well as Avandia and Actos, she said, but studies have turned up an
increased risk for heart attack and heart failure in the last two
drugs. The FDA has removed Avandia from pharmacy shelves, and the
agency issued a warning last summer that there is a possible
increased risk of bladder cancer in patients who take Actos for
more than a year.
The concerns about Januvia and Byetta "should not be blown out
of proportion," Banerji said. "You prescribe them on an individual
basis, because, in the end, all of medicine is individual," she
said. "We should use these drugs judiciously along with
Industry representatives, insisting that no studies involving
these drugs have found an increased risk of pancreatitis or
pancreatic cancer, stand by their products. The database used for
the study contains information on doctor-reported cases and does
not reflect cause-and-effect, they said.
Dr. Barry Goldstein, vice president and therapeutic area head
for diabetes and endocrinology at Merck Research Laboratories,
which makes Januvia, said that "there has been no association shown
between Januvia and pancreatitis."
"We have full confidence in Januvia, which is used by millions of patients around the world," he said.
Anne Erickson, a spokeswoman for Amylin Pharmaceuticals, makers
of Byetta, said that "the conclusions of the study are in contrast
to other nonclinical, clinical and adequately conducted
post-marketing epidemiological studies."
Epidemiological studies have not established a significantly
increased risk of pancreatitis associated with Byetta, she said.
"To date, the available data do not demonstrate that exenatide
increases the overall risk of cancer in humans."
Another expert, Dr. Ronald Goldberg, professor of medicine,
biochemistry and molecular biology at the University of Miami
Miller School of Medicine, said the findings merit consideration.
"I don't think the study is definitive, but it raises a flag and is
clearly something we need to pay attention to going forward."
There is "more benefit than risk with these drugs, based on our
current knowledge," he said.
For more information on diabetes, visit the
U.S. National Library of Medicine.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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