Are New Diabetes Drugs Dangerous?

Monday, 10 Jun 2013 05:16 PM

By Nick Tate

Share:
  Comment  |
   Contact Us  |
  Print  
|  A   A  
  Copy Shortlink
Concerns about the safety of a new class of diabetes medicines increased a notch this week with a new report by medical investigators working for the British Medical Journal and a U.K. documentary TV show that revealed unpublished data link the drugs to "unwanted proliferative or inflammatory pancreatic effects."

The report comes as health regulators in the U.S. and Europe are reviewing the safety of the lucrative drugs — known as incretin therapies and promoted as "the new darlings of diabetes treatment," the BMJ article notes. Past research has tied the meds to an increased risk of pancreatic cancer.
 
The BMJ report calls for the release of all safety information by companies that make such drugs, which include so-called glucagon-like peptide-1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors. The reporters argue that the Food and Drug Administration and the European Medicines Agency have not adequately responded to research suggesting the drugs, introduced in 2006, are less safe than manufacturers claim.
 
In the course of the investigation, the BMJ reviewed thousands of pages of regulatory documents obtained under the Freedom of Information Act. The data showed companies have not performed critical safety studies and regulators have not demanded them, according to the report.
 
"On their own the individual pieces of unpublished evidence may seem inconclusive," said Deborah Cohen, M.D., the BMJ's Investigation Editor. "But when considered alongside other emerging and long-standing evidence, a worrying picture emerges, posing serious questions about the safety of this class of drug."
 
Dr. Cohen acknowledged that regulatory agencies are now reviewing the safety of the drugs. More information is expected this month, when the National Institutes of Health holds a meeting on possible links between diabetes, diabetes drugs, and pancreatic cancer.
Incretin therapies are taken by millions of people with Type 2 diabetes, with a global market of an estimated $9 billion a year. GLP-1 based drugs treat diabetes by regulating blood sugar. Some also suppress appetite and are being tested as a possible treatment for obesity.
 
Concerns about the drugs were first raised by by Peter Butler, M.D., from the University of California-Los Angeles, whose research showed pancreatic abnormalities in rats given the DPP-4 inhibitor sitagliptin (trade name: Januvia, made by Merck) several years ago. Dr. Butler later also found precancerous lesions in the pancreases of organ donors taking GLP-1–based drugs.
 
Three publications this year have raised concerns about the potential side effects of the drugs, prompting both the FDA and EMA to launch a review into whether the drugs may cause or contribute to the development of pancreatic cancer. But many scientists and manufacturers defend the drugs’ safety, saying the research evidence is weak.
 
The drugs in question reportedly include injectable GLP-1 agonists, exenatide (Byetta, Amylin/Lilly) and liraglutide (Victoza, Novo Nordisk); the oral DPP-4 inhibitors sitagliptin, saxagliptin (Ongylza, AstraZeneca/Bristol-Myers Squibb); linagliptin (Tradjenta, Boehringer Ingelheim/Lilly); and the recently approved alogliptin (Takeda).
 
Some consumer groups are calling for the drugs to be withdrawn until safety questions are settled.
 
"All drug licensing is about balancing benefits and risks," said Fiona Godlee, M.D., BMJ editor-in-chief, in a commentary accompanying the new report. "But instead of engaging in open debate about legitimate and important scientific questions, the manufacturers have been unwilling to share their data. Meanwhile patients and doctors have not been kept properly informed about the uncertainties surrounding these drugs.
 
"The debate would be much easier to resolve if all the information was placed in the public domain so scientists, doctors and ultimately patients could make up their own minds."
 
In statements to the Channel 4 documentary "Dispatches" airing Monday, the drug companies said they are committed to patient safety and have vigorous safety processes in place.

© 2014 NewsmaxHealth. All rights reserved.

Share:
  Comment  |
   Contact Us  |
  Print  
  Copy Shortlink
Around the Web
Join the Newsmax Community
Please review Community Guidelines before posting a comment.
>> Register to share your comments with the community.
>> Login if you are already a member.
blog comments powered by Disqus
 
Email:
Retype Email:
Country
Zip Code:
 
Hot Topics
Follow Newsmax
Like us
on Facebook
Follow us
on Twitter
Add us
on Google Plus
Around the Web
You May Also Like

Ebola Can Spread by Air Travel: Health Authorities

Sunday, 27 Jul 2014 16:32 PM

Nigerian health authorities raced to stop the spread of Ebola on Saturday after a man sick with one of the world's deadl . . .

More Than 2,500 9/11 Emergency Workers Have Cancer

Sunday, 27 Jul 2014 13:56 PM

A growing number of Ground Zero responders and rescuers are seeking compensation for their illnesses, and more than 2,50 . . .

FDA Considers Lifting Ban on Gay Blood Donation

Sunday, 27 Jul 2014 10:33 AM

The United States should repeal a 30-year policy that bans blood donations from gay and bisexual men, according to a tea . . .

Most Commented

Newsmax, Moneynews, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, NewsmaxWorld, NewsmaxHealth, are trademarks of Newsmax Media, Inc.

 
NEWSMAX.COM
America's News Page
©  Newsmax Media, Inc.
All Rights Reserved