Pantoprazole now on Conditional TdP Risk List

September 26, 2014 at 7:37 PM

After receiving a report of cardiac arrest in a patient who was taking long-term esomeprazole therapy, CredibleMeds® analyzed the available cardiac safety data for each of the six proton pump inhibitors (PPIs) marketed in the US for the treatment of gastro-esophageal reflux disease (GERD).  All six PPIs have uniform product labeling that includes a warning of rare but serious episodes of hypomagnesemia (low serum magnesium) associated with prolonged therapy (>3-12 months) (See FDA warning March 2011).  These warning are supported by numerous case reports in the medical literature and hundreds of reports submitted to the FDA’s Adverse Event Reporting System (AERS).

 

Because the prolonged use of a PPI can cause hypomagnesemia and hypokalemia, conditions that prolong cardiac repolarization and facilitate torsades de pointes (TdP) cardiac arrhythmia, it is biologically plausible that chronic PPI therapy can result in TdP.  After review of the available evidence, CredibleMeds® has concluded that, at this time, pantoprazole (Protonix® brand in the US)* should be added to the list of drugs with “Conditional Risk of TdP.”  For the other PPIs (omeprazole, esomeprazole, lansoprazole, dexlansoprazole and rabeprazole), there are case reports in the literature and numerous reports of QT prolongation, TdP and cardiac death in AERS but the evidence has not yet met the CredibleMeds® threshold for causality.

 

In summary, CredibleMeds® has added pantoprazole to the “Conditional TdP Risk” list because of substantial and convincing evidence that, when taken for extended periods of time, this drug can cause hypomagnesemia and/or hypokalemia and indirectly result in TdP.  Pantoprazole has also been added to the list of “Drugs to Avoid in Patients with congenital Long QT.  Prolonged use (>14 days) of any PPI should be discouraged in this special population because of their inherent high risk of TdP.

 

*Other international brand names are Pantazone, Pantop-D, Pantasan, Pantrol, Prazolin, Pantochem, Pansev, Pantec, Somac, API, Tecta, Protium, Pantodac, Perizole, Pansped, Percazole, Astropan, Fenix, Pantecta, Pantoloc, Controloc, Somac, Tecta, Protium, Inipomp, Eupantol, Pantozol, Pantodac, Perizole, Pansped, Zurcazol, Pantup,Pantomed, TopZole, Nolpaza, Controloc, UXL-D, Pantid, Pantogen, Pantpas and Prazolin.




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Posted by mundrome on
Ouch GI doc's again in a specialty so isolated. thy never hear the basics..in spite of plenty of warning they all seem to prescribethe Proton Pump and insist on ignoring the FDA warnings..and sem to enjoy prescribing the "latesT' and Most horribly expensive. And Guess what Boys and girls, theu stillinsist on wielding their expensive $cope . even if the diagnosis is pretty clear, and wil be clearer and safe to ru early atig,meds, simple antacids, and perhaps the short onset cheap-old drugs like famotidine..OTC! far and away the best and the very cheapest of thes one time miracle Drugs.. so up the dose to 80 mig bid first two days. Relief in an hour or less as opposed to 18-24 hrs for P{PO's

AND THOSE OF US WHO AE WELLROUDED AND GREYING ALWAS SHOW TH PT HOW tO RAISE HE HEAD OF THE BED,SLEEPFLAT WITHOUT BENDNG AT THE
wast, clam down those emotions, reat, use no alcolhol, dont eat two hours befor reclining..

Did a survey of our R mountain GI gus tjhs year.. they are all convinced their skills are so good they dont bother to take a good history all rx ppo s as first line, and dont like the bother to order the basic tsts for helico bacter..

AND DOEs ANYBDY REMEMBER THAT if you stop acid production you are not stopping the reflux, choking, respiratory and vocal cord dstress..They arew plenty of other digestive enzymes in the ups-.YOU ARE NOT HELPING THE PATIENT!! 4 inch blocks under the head of the bed and fllow the other rules relives a lot of cases..But alas might interrupt the flow of new and recurrent patients into the $coping unit.. and good heavens, that pre cancerous endothelium doesnt look like it's the risk we once GUESSED it would..

Mundrome. (44 years in practice, and a whole electrical engineer life before Med school..And knew about simple treatments for clincal Giardiasis based on history and odor alone
before i ever started private practice.. Happy Turkeyday folks!
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