FDA Considers Studying Januvia, Byetta, Victoza Long Term

Our attorneys can help you with injuries from diabetes drugsAfter months that have added up to years of concern that the newest class of Type 2 Diabetes drug treatments cause pancreatitis and possibly pancreatic cancer, the FDA is deciding whether to order long term studies of the drugs’ effects on humans.  It appears that the FDA will either conduct the studies themselves, or have the drugs manufacturers do so.  The meeting to discuss and figure this out is taking place at the National Institutes of Health.

The class of diabetes drugs in question are incretin mimetics, also known as GLP-1 based therapies.  These drugs stimulate insulin production by the pancreas in order to regulate blood sugar.  They include the following drugs:

  • Eli Lilly’s Tradjenta

More and more studies are being published with disturbing findings.  In March, Diabetes journal published a study showing that those taking these drugs showed a 40% increase in cellular changes that could lead to pancreatic cancer.

In another evaluation of adverse events reported to the FDA, a watchdog group calculated that the odds of a pancreatitis report being filed in association with an injectable GLP-1 drug (Victoza and Byetta) are 28.5% higher than with older treatments such as metformin.  With the regular pill versions of the incretin mimetics, the odds were 20 times higher.

Public Citizen Health Research Group wants the FDA to ban these drugs altogether.  They point to the fact that there is no known benefit to this new class of drugs, but there seem to be very serious side effects to them.

Even if the FDA does order these studies to be done, the results of these long-term studies are years and years away.  In the meantime, patients are taking these drugs, not knowing if they are really safe or not.  It is likely that a good many of these patients will end up with complications that they never expected.  The drug companies have nothing to lose, as they rack up billions in annual sales.

Look at at the numbers: last year, Januvia brought in $4.1 billion for Merck, while Victoza brought in $1.6 billion for Novo Nordisk.  With celebrity endorsements such as Paula Deen, boasting Victoza as a magic pill for her ailment, the unknowing public continues to trust that the pills that they take are safe.

Even after the drug world was only recently rocked by the huge liability that GlaxoSmithKline faced after the Avandia debacle, drug manufacturers would rather sell their drugs now, and face their slaps on the wrist later.  Whatever fine or liability they are left with will be only a small fraction of their sales anyway.

Have you or a loved one been taking Byetta, Januvia, Victoza, or another incretin mimetic diabetes treatment?  If you have, you should be aware of the possibility of serious complications.  If you have experienced any symptoms of pancreatitis or pancreatic cancer, you should consult with your doctor immediately.  You may be entitled to compensation for your injuries as well.  Only an experienced drug and device attorney can provide you with the immediate answers that you need.  Contact an attorney at Kirkendall Dwyer LLP today to see if you may be entitled to compensation for your injuries.  The drug companies should be held responsible for the drugs that they place on the market and profit from.

If you are interested in reading more about these drugs and their risks, click here and here.

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