A Drug Safety Controversy Continues: Whether It Is The Diabetes Drug Or The Diabetes Which Causes Pancreas Disease

(Posted by Tom Lamb at DrugInjuryWatch.com)

As regards the possible association between Victoza and pancreatitis as a side effect of this diabetes drug from Novo Nordisk, there have been quite a few assorted developments during the period April 2011 to April 2012. In order to get those all out in front of us, and so as to see how this drug safety issue emerged and where it may be headed going forward, we offer the following time-line of sorts.

 
April 2010

"Acute Pancreatitis Associated with Liraglutide", The Annals of Pharmacotherapy.

"Medical Journal Withdraws Article About Januvia And Byetta After It Gets Letters From Two Drug Companies", Drug Injury Watch.

According to a news item published April 11, 2011 by The British Medical Journal (BMJ), letters written by Merck and Novo Nordisk to Anil Rustgi, the editor-in-chief of Gastroenterology, resulted in that journal withdrawing an article which it had posted on its website about how Januvia (sitagliptin) and Byetta (exenatide) have been associated with an increased risk of pancreatitis as well as several cancers.

From this April 2011 BMJ piece, "Journal withdraws article after complaints from drug manufacturers"….

P.S.  The diabetes drug Januvia is marketed by Merck.

Byetta is marketed by Amylin Pharmaceuticals and Eli Lilly.

Novo Nordisk has a relatively new diabetes drug, Victoza (approved by FDA in 2010), which is in the same class of drugs as Byetta.  Victoza (liraglutide) has been linked to pancreatitis, also.

 

June 2011

"FDA Warns of Serious Risks Associated With [Victoza (Liraglutide)]", Medscape.

Victoza (liraglutide [rDNA origin]) Injection: REMS – Risk of Thyroid C-cell Tumors, Acute Pancreatitis, FDA.

Dear Healthcare Professional Letter, Novo Nordisk.

"Acute Pancreatitis Case Associated With Victoza Use, Similar To Byetta And Januvia Case Reports", Drug Injury Watch.

March 2012

"Liraglutide-associated acute pancreatitis.", American Journal of Health–System Pharmacy.

April 2012

"Public Citizen to FDA: Pull Diabetes Drug Victoza From Market Immediately", Press Release issued by Public Citizen.

Petition to Ban Diabetes Drug Liraglutide (Victoza), Letter to FDA from Public Citizen.

"Novo Nordisk rejects diabetes drug Victoza complaint", Reuters

With Novo Nordisk and Public Citizen engaged in this public battle, now, about a year after the Victoza and pancreatitis link first received some profile, I am sure there is much more to come on all fronts, including the FDA, as we go forward.  Of course, we will be watching….

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