Posted on 02/09/2012 11:18:31 PM PST by neverdem
Safety Announcement
Additional Information for Patients and Consumers
Additional Information for Healthcare Professionals
Data Summary (Tables)
[02-08-2012] The U.S. Food and Drug Administration (FDA) is informing the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD). A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhea that does not improve.
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Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve.
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Facts about Proton Pump Inhibitor (PPI) Drugs |
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Clostridium difficile (C. difficile) is a bacterium that can cause diarrhea that does not improve.1 Symptoms include watery stool, abdominal pain, and fever, and patients may go on to develop more serious intestinal conditions. The disease can also be spread in the hospital. Factors that may predispose an individual to developing CDAD include advanced age, certain chronic medical conditions, and taking broad spectrum antibiotics. Treatment for CDAD includes the replacement of fluids and electrolytes and the use of special antibiotics.
The FDA is working with manufacturers to include information about the increased risk of CDAD with use of PPIs in the drug labels.
FDA is also reviewing the risk of CDAD in users of histamine H2 receptor blockers. H2 receptor blockers are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and heartburn. H2 receptor blockers are marketed under various brand and generic drug names (see Tables 3 and 4) as prescription and OTC products.
Today's communication is in keeping with FDA's commitment to inform the public about the Agency's ongoing safety review of drugs. FDA will communicate any new information on PPIs or H2 receptor blockers and the risk of CDAD when it becomes available.
Additional Information for Patients and OTC Consumers:
Additional Information for Healthcare Professionals
FDA has reviewed reports from the FDA's Adverse Event Reporting System (AERS) and the medical literature for cases of Clostridium difficile-associated diarrhea (CDAD) in patients undergoing treatment with PPIs. Many of the adverse event reports involved patients who were elderly, had chronic and/or concomitant underlying medical conditions, or were taking broad spectrum antibiotics that could have predisposed them to developing CDAD. Although these factors could have increased their risk of CDAD, the role of PPI use cannot be definitively ruled out in these reviewed reports. Patients who have one or more of these risk factors may have serious outcomes from CDAD with concomitant PPI use.
FDA also reviewed a total of 28 observational studies described in 26 publications. Twenty-three of the studies showed a higher risk of C. difficile infection or disease, including CDAD, associated with PPI exposure compared to no PPI exposure.2-27 Although the strength of the association varied widely from study to study, most studies found that the risk of C. difficile infection or disease, including CDAD, ranged from 1.4 to 2.75 times higher among patients with PPI exposure compared to those without PPI exposure. In the five studies that provided information on clinical outcomes, colectomies, and rarely deaths, were reported in some patients 4,6,11,12,21
The published studies varied in their ability to assess the association between C. difficile infection or CDAD and prior PPI use. There were limited data on the relationship between the risk of C. difficile infection or CDAD and PPI dose and duration of use. There also was little information on the use of OTC PPIs in community settings in these studies. Nevertheless, the weight of evidence suggests a positive association between the use of PPIs and C. difficile infection and disease, including CDAD.
References
Table 1: Prescription Proton Pump Inhibitor (PPI) Drugs
| Generic name | Found in brand name(s) |
|---|---|
| dexlansoprazole | Dexilant |
| esomeprazole magnesium | Nexium |
| esomeprazole magnesium and naproxen | Vimovo |
| lansoprazole | Prevacid |
| omeprazole | Prilosec |
| omeprazole and Sodium bicarbonate | Zegerid |
| pantoprazole sodium | Protonix |
| rabeprazole sodium | AcipHex |
Table 2: Over-the-Counter (OTC) Proton Pump Inhibitor (PPI) Drugs
| Generic name | Found in brand name(s) |
|---|---|
| lansoprazole | Prevacid 24HR |
| omeprazole magnesium | Prilosec OTC |
| omeprazole and sodium bicarbonate | Zegerid OTC |
| omeprazole | Omeprazole |
Table 3: Prescription H2 Receptor Blocker Drugs
| Generic name | Found in brand name(s) |
|---|---|
| cimetidine | Tagamet |
| famotidine | Pepcid, Duexis |
| nizatidine | Axid, Nizatidine |
| ranitidine | Zantac, Tritec |
Table 4: Over-the-Counter (OTC) H2 Receptor Blocker Drugs
| Generic name | Found in brand name(s) |
|---|---|
| cimetidine | Tagamet HB |
| famotidine | Pepcid Complete, Pepcid AC |
| nizatidine | Axid AR |
| ranitidine | Zantac |
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville,
MD 20857
Apparently you need at least some acid in the stomach to keep those bugs under control.....
Many times, heartburn and reflux are due to too little acid in the stomach. Doctors and patients are too quick to prescribe or head to the medicine cabinet when a little pickle, lemon, or vinegar would suffice.
Reflux due to too little acid?????
Whatever.
All I can say is until you have suddenly jerked awake in the night, choking on a big shot of hydrochloric acid that has made its way up your esophagus and down your windpipe and into your lungs while you were asleep, then you have no clue how fast I will kill you if you try to take away my PPIs.
I’ll take the risk of a case of the runs in order to prevent more acid destruction to what is left of my lungs, thank you very much.
Ping...(Thanks, neverdem!)
Thankfully, most people can’t even imagine how frightening this can be. Mrs. panax suffers from the same thing as you. It is a terrible affliction.
Good luck...panax
http://www.webmd.com/heartburn-gerd/laryngospasm-causes-symptoms-and-treatments
Another link that may be helpful for those who suffer from laryngospasms.
http://www.heartburn-help.com/MessageBoard36/_disc16/00000083.htm
“when a little pickle, lemon, or vinegar would suffice.”
My Chinese herb doctor had me doing shots of rice vinegar. The thing that helped the most, as far as waking up choking, which is terrifying, was raising the head of my bed about 5”. Stopped the night chokes immediately!
So that’s what that was. I’ve done that too. Been on Zantac for about 15 years.
Try being a celiac with a hiatal hernia. I take omeprazole every day to combat the involuntary removal of esophageal lining. This because tums isn’t really an option for a celiac, and as many as I’d been eating, I might as well have had stock in the company, with dividends paid in product. No problems with CDAD here, either. Only celiac disease. I’m not at all worried about the other. That pales in comparison to CD and, say, stomach cancer.
Thanks.
I used real apple cider vinegar with the mother, not the apple cider flavored stuff, during both of my pregnancies. Works like a charm!
Interesting - a few years ago my then 11 year old daughter was suffering from the symptoms of ulcerative colitis. Her GI doctor suggested she take twice the amount of Prevacid than normal. She eventually ended up in the hospital with C diff.
This why third world menus include hot peppers.
You’re very welcome.
been there done that... first they came for my pain medication, then they came for my anti-histimines, now they are coming for my stomach acid drugs.... what will be outlawed next?
Apple works for me,
though I don’t get reflux often.
One thing that works for mild acid reflux....a spoonful of oats. They think it’s something about the oat fiber causes the esophagal valve to close.
This is bizarrely interesting.
Typically, c. difficile outbreaks are caused by the use of potent spectrum antibiotics, used more frequently these days because of resistant strains of bacteria, and also by potent chemotherapy chemicals that wipe out much of the intestinal flora.
Both of these causes can also open the door to extremely dangerous infections by drug resistant bacteria.
Background: Human intestinal flora includes some 300-1000 different types of bacteria, of which only 30-40 types take up almost all the physical space. The rest of the bacteria are mostly harmless, but some are pathogenic.
Typically, humans have some drug resistant bacteria in them, which cause no problem *unless* the “majority” bacterial cultures have been damaged. This creates the opportunity for a “space race” population explosion by the drug resistant bacteria. And while a little bit of them are not harmful, a large number of them produce so much deadly toxin as waste that they can kill.
Importantly, when outbreaks of these drug resistant bacteria happen in hospitals, considerable success in subduing them has been achieved by using tight controls over the use of antibiotics.
However, that proton pump drugs can cause an outbreak of c. difficile raises a whole bunch of questions and possibilities.
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