SITAGLIPTIN...Controversy vs Explanation

Submitted by Sirisha Pingali on Wed, 09/30/2009 - 04:30

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Recently FDA notified healthcare professionals that Januvia (sitagliptin) and Janumet (sitagliptin/metformin) are known to cause severe pancreatitis as on Sep 25th. Following this alert, Merck responded in the following way..
"Merck has thoroughly reviewed the safety data for sitagliptin, and sitagliptin was not associated with an increase in the incidence of pancreatitis in preclinical studies or in clinical trials of up to two years in duration with more than 6,000 patients. Merck has also carefully reviewed post marketing adverse experience reports, and Merck believes these data do not demonstrate that a causal relationship exists between sitagliptin and pancreatitis. Merck appreciates the important role that the FDA plays in assessing the safety of medicines and, as we do with all of our medicines, we will continue to monitor the safety of JANUVIA and will share the data with regulatory agencies and the medical community," said John Amatruda, M.D., Senior Vice President and Franchise Head, Diabetes and Obesity, Merck Research Laboratories.
"Patients with type 2 diabetes are more likely to develop pancreatitis than other people" he added.
I was surprised to see that both the alerts ie. reg usage of sitagliptin and Merck responding to the alert happened to be on the same date.

Reference:
Pharmaceutical News and Articles @ www.drugs.com

Dear readers, I'll let you know any further developments in this issue.

sirisha's blog
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260 reads

good ........keep posting

Submitted by SUPRIYA VAVILAPALLI on Sun, 10/11/2009 - 11:59.

good ........keep posting such informative blogs.

SUPRIYA VAVILAPALLI

THE COGNITIVE MOLECULES

dear supriya.. Thank you for

Submitted by Sirisha Pingali on Sun, 10/25/2009 - 12:20.

dear supriya..
Thank you for your valuable comment...

Sirisha Pingali
www.pharmainfo.net/sirisha

Nice update ma'am.

Submitted by Juhi Sharma on Fri, 10/09/2009 - 07:56.

Nice update ma'am.

Juhi Sharma
Team Infinity
"∞"
http://www.pharmainfo.net/blog/team-infinity

dear juhi.. thank you for

Submitted by Sirisha Pingali on Fri, 10/09/2009 - 15:17.

dear juhi..
thank you for your valuable comment..

Sirisha Pingali
www.pharmainfo.net/sirisha

Dear... Is by any chance

Submitted by Zarrin Faria on Tue, 10/06/2009 - 08:24.

Dear...
Is by any chance merck planning to call these drug from the market or making a change in the labels of these drugs...
Regards,
Faria Zarrin
Team: BLOGBUSTERS

My Page :
http://www.pharmainfo.net/zarrinfaria

My Team:
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Dear Ms. Zarrin, I would like

Submitted by Nikhil on Wed, 10/07/2009 - 05:45.

Dear Ms. Zarrin,
I would like to reply to your query.

Plz see my reply to sirisha's blog, where i have explained in detail.

FDA is working with Innovator to revise the details.

thank you sir for your quick

Submitted by Sirisha Pingali on Fri, 10/09/2009 - 15:16.

thank you sir for your quick reply..

Sirisha Pingali
www.pharmainfo.net/sirisha

Good Blog!!!

Submitted by ks kumar upadhyayula on Thu, 10/01/2009 - 19:04.

Dear Sirisha,

latest and good news updates from your side.Keep on updating and just try to put your explanation in your blogs in a detailed manner.

Regards,
K.S.Kumar Upadhyayula.

Regards,

"PHARMERS"
http://www.pharmainfo.net/ks-kumar-upadhyayula

dear suresh.. Thank you for

Submitted by Sirisha Pingali on Fri, 10/02/2009 - 14:56.

dear suresh..
Thank you for your valuable comment..Ya i'll make sure of that..

Sirisha Pingali
www.pharmainfo.net/sirisha

Good information.

Submitted by C Rajan Raju on Wed, 09/30/2009 - 15:23.

GOod,
Keep updating us. This is interesting.

Regards
Rajan raju
" KINDLERS "

www.pharmainfo.net/rajaraju

dear rajan Thank you for your

Submitted by Sirisha Pingali on Wed, 09/30/2009 - 15:53.

dear rajan
Thank you for your valuable comment..

Sirisha Pingali
www.pharmainfo.net/sirisha

Different aspect

Submitted by Nikhil on Wed, 09/30/2009 - 09:05.

Dear Ms. Sirisha,

nice blog, BUT-

The notification & Mercks reply to it, is not exactly as you have put it.

According to AERS between Oct 2006 to Feb 2009, there were 88 cases of acute pancreatitis in patients taking Sitagliptine & sitagliptine/Metformin.

(The analysis found that 19 of the 88 reported cases (21%) of pancreatitis occurred within 30 days of starting sitagliptin or sitagliptin / metformin. Furthermore, 47 of the 88 cases (53%) resolved once sitagliptin was discontinued. It is important to note that 45 cases (51%) were associated with at least one other risk factor for developing pancreatitis, such as diabetes, obesity, high cholesterol and/or high triglycerides. It is important to note that 45 cases (51%) were associated with at least one other risk factor for developing pancreatitis, such as diabetes, obesity, high cholesterol and / or high triglycerides.)

Based on the teporal relationship of Initiating sitagliptin or sitagliptin / metformin and development of acute pancreatitis in the reviewed cases, FDA believes there may be an association between these events.

Based on these reports, FDA is working with the manufacturer of sitagliptin and sitagliptin / metformin to revise the prescribing information to include:

1) information regarding post marketing reports.
2) Information that - regular monitoring of patients on sitagliptine therapy to avoid development of pancreatitis.
3) Information noting that sitagliptin has not been studied in patients with a history of pancreatitis.

sir.. Thank you for your

Submitted by Sirisha Pingali on Wed, 09/30/2009 - 15:52.

sir..
Thank you for your valuable comment..
Infact you gave a vivid explanation..I also referred AERS after seeing your post. Please give your suggestions and let me know my mistakes so that i can improve my efficiency in presenting blogs. Thank you sir.

Sirisha Pingali
www.pharmainfo.net/sirisha