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Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as...
FDA ^ | 02-08-2012 | NA

Posted on 02/09/2012 11:18:31 PM PST by neverdem

FDA Drug Safety Communication: Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)

 

Safety Announcement
Additional Information for Patients and Consumers
Additional Information for Healthcare Professionals
Data Summary (Tables)

 

Safety Announcement

[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.

Facts about Proton Pump Inhibitor (PPI) Drugs

  • Marketed under various brand and generic drug names (see Tables 1 and 2) as prescription and over-the-counter (OTC) products.
  • Work by reducing the amount of acid in the stomach.
  • Prescription PPIs are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.
  • Over-the-counter PPIs are used to treat frequent heartburn.

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 

 

Data Summary

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

  1. U.S. National Library of Medicine. National Institutes of Health. Health topics-Clostridium difficile infections. http://vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?v%3Aproject=medlineplus&query=clostridium+difficile+infections. Accessed January 31, 2012.
  2. Al-Tureihi FIJ, Hassoun A, Wolf-Klein G, et al. Albumin, length of stay, and proton pump inhibitors: key factors in Clostridium difficile-associated disease in nursing home patients. J Am Med Dir Assoc. 2005;6:105-108.
  3. Cunningham R, Dale B, Undy B, et al. Proton pump inhibitors as a risk factor for Clostridium difficile diarrhoea. J Hosp Infect. 2003;(54):243-245.
  4. Dial S, Alrasadi K, Manoukian C, et al. Risk of Clostridium difficile diarrhea among hospital inpatients prescribed proton pump inhibitors: cohort and case-control studies. CMAJ. 2004;171(1):33-38.
  5. Dial S, Delaney JAC, Barkun A, et al. Use of gastric acid-suppressive agents and the risk of community-acquired Clostridium difficile-associated disease. JAMA 2005;294(23):2989-2995.
  6. Muto C, Pokrywka M, Shutt K, et al. A large outbreak of Clostridium difficile associated disease with an unexpected proportion of deaths and colectomies at a teaching hospital following increased fluoroquinolone use. Infect Control Hosp Epidemiol. 2005;26:273-280.
  7. Pepin J, Saheb N, Coulombe M-A, et al. Emergence of fluoroquinolones as the predominant risk factor for Clostridium difficile-associated diarrhea: a cohort study during an epidemic in Quebec. Clin Infect Dis. 2005;41(9):1254-1260.
  8. Shah S, Lewis A, Leopold D, et al. Gastric acid suppression does not promote clostridial diarrhoea in the elderly. QJM .2000;93:175-181.
  9. Dial S, Delaney JAC, Schneider V, et al. Proton pump inhibitor use and risk of community-acquired Clostridium difficile-associated disease defined by prescription for oral vancomycin therapy. CMAJ. 2006;175(7):745-748.
  10. Dial S, Kezouh A, Dascal A, et al. Patterns of antibiotic use and risk of hospital admission for Clostridium difficile infection among elderly people in Quebec. CMAJ. 2008;179:767-772.
  11. Loo VG, Poirier L, Miller MA, et al. A predominantly clonal multi-institutional outbreak of Clostridium diffcile-associated diarrhea with high morbidity and mortality. N Engl J Med. 2005;353:2442-2449.
  12. Akhtar AJ, Shaheen M. Increasing incidence of Clostridium difficile-associated diarrhea in African-American and Hispanic patients: association with the use of proton pump inhibitor therapy. J Natl Med Assoc. 2007;99(5):500-504.
  13. Aseeri M, Schroeder T, Kramer J, et al. Gastric acid suppression by proton pump inhibitors as a risk factor for Clostridium difficile-associated diarrhea in hospitalized patients. Am J Gastroenterol. 2008;103(9):2308-2313.
  14. Beaulieu M, Williamson D, Pichette G, et al. Risk of Clostridium difficile associated disease among patients receiving proton-pump inhibitors in a Quebec medical intensive care unit. Infect Control Hosp Epidemiol. 2007;28(11):1305-1307.
  15. Cadle R, Mansouri M, Logan N, et al. Association of proton-pump inhibitors with outcomes in Clostridium difficile colitis. Am J Health Syst Pharm. 2007;64(22):2359-2363.
  16. Dalton B, Lye-Maccannell T, Henderson E, et al. Proton pump inhibitors increase significantly the risk of Clostridium difficile infection in a low-endemicity, non-outbreak hospital setting. Aliment Pharmacol Ther. 2009;29(6):626-634.
  17. Dubberke ER, Reske KA, Yan Y, et al. Clostridium difficile-associated disease in a setting of endemicity: identification of novel risk factors. Clin Infect Dis. 2007;45(12):1543-1549.
  18. Howell MD, Novack V, Grgurich P, et al. Iatrogenic gastric acid suppression and the risk of nosocomial Clostridium difficile infection. Arch Intern Med. 2010;170(9):784-790.
  19. Janarthanan S, Ditah I, Kutait A, et al. A meta-analysis of 16 observational studies on proton pump inhibitor use and risk of Clostridium difficile associated diarrhea [abstract]. American College of Gastroenterology Conference 2010;Abstract 378.
  20. Jayatilaka S, Shakov R, Eddi R, et al. Clostridium difficile infection in an urban medical center: five-year analysis of infection rates among adult admissions and association with the use of proton pump inhibitors. Ann Clin Lab Sci. 2007;37(3):241-247.
  21. Kazakova SV, Ware K, Baughman B, et al. A hospital outbreak of diarrhea due to an emerging epidemic strain of Clostridium difficile. Arch Intern Med. 2006;166(22):2518-2524.
  22. Kim JW, Lee KL, Jeong JB, et al. Proton pump inhibitors as a risk factor for recurrence of Clostridium-difficile-associated diarrhea. World J Gastroenterol. 2010;16(28):3573-3577.
  23. Leonard J, Marshall JK, Moayyedi P. Systematic review of the risk of enteric infection in patients taking acid suppression. Am J Gastroenterol. 2007;102(9):2047-2056.
  24. Linsky A, Gupta K, Lawler EV, et al. Proton pump inhibitors and risk for recurrent Clostridium difficile infection. Arch Intern Med. 2010;170(9):772-778.
  25. Lowe DO, Mamdani MM, Kopp A, et al. Proton pump inhibitors and hospitalization for Clostridium difficile-associated disease: a population-based study. Clin Infect Dis. 2006;43(10):1272-1276.
  26. Turco R, Martinelli M, Miele E, et al. Proton pump inhibitors as a risk factor for paediatric Clostridium difficile infection. Aliment Pharmacol Ther. 2010;31(7):754-759.
  27. Yearsley K, Gilby L, Ramadas A, et al. Proton pump inhibitor therapy is a risk factor for Clostridium difficile-associated diarrhoea. Aliment Pharmacol Ther. 2006;24(4):613-9.

 

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

-

Related Information

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Contact FDA

1-800-332-1088

1-800-FDA-0178 Fax
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Mail to: MedWatch 5600 Fishers Lane

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TOPICS: Culture/Society; Government; News/Current Events; Testing
KEYWORDS: cdad; diarrhea; gerd; medicine; microbiology; ppi

1 posted on 02/09/2012 11:18:34 PM PST by neverdem
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To: Mother Abigail; EBH; vetvetdoug; Smokin' Joe; Global2010; Battle Axe; null and void; ...
FReepmail me if you want on or off my combined microbiology/immunology ping list.
2 posted on 02/09/2012 11:21:45 PM PST by neverdem (Xin loi minh oi)
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To: neverdem

Apparently you need at least some acid in the stomach to keep those bugs under control.....


3 posted on 02/09/2012 11:31:56 PM PST by Frank_2001
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To: neverdem

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.


4 posted on 02/09/2012 11:39:09 PM PST by PeaceBeWithYou (De Oppresso Liber! (50 million and counting in Afghanistan and Iraq))
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To: PeaceBeWithYou

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.


5 posted on 02/10/2012 12:10:53 AM PST by Nik Naym (It's not my fault... I have compulsive smartass disorder.)
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To: 2ndreconmarine; Fitzcarraldo; Covenantor; Mother Abigail; EBH; Dog Gone; ...

Ping...(Thanks, neverdem!)


6 posted on 02/10/2012 1:37:42 AM PST by Smokin' Joe (How often God must weep at humans' folly. Stand fast. God knows what He is doing)
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To: Nik Naym

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


7 posted on 02/10/2012 2:02:30 AM PST by panaxanax (0bama >>WORST PRESIDENT EVER.)
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To: Nik Naym

Another link that may be helpful for those who suffer from laryngospasms.

http://www.heartburn-help.com/MessageBoard36/_disc16/00000083.htm


8 posted on 02/10/2012 2:08:37 AM PST by panaxanax (0bama >>WORST PRESIDENT EVER.)
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To: PeaceBeWithYou; Nik Naym

“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!


9 posted on 02/10/2012 3:32:36 AM PST by Dr. Bogus Pachysandra ( Ya can't pick up a turd by the clean end!)
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To: Nik Naym

So that’s what that was. I’ve done that too. Been on Zantac for about 15 years.


10 posted on 02/10/2012 3:41:15 AM PST by Vigilantcitizen
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To: PeaceBeWithYou

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.


11 posted on 02/10/2012 3:41:25 AM PST by sayuncledave (et Verbum caro factum est (And the Word was made flesh))
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To: panaxanax

Thanks.


12 posted on 02/10/2012 3:45:34 AM PST by Vigilantcitizen
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To: PeaceBeWithYou

I used real apple cider vinegar with the mother, not the apple cider flavored stuff, during both of my pregnancies. Works like a charm!


13 posted on 02/10/2012 3:47:01 AM PST by goodwithagun (My gun has killed fewer people than Ted Kennedy's car.)
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To: neverdem

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.


14 posted on 02/10/2012 3:47:41 AM PST by Carpe Cerevisi
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To: neverdem

This why third world menus include hot peppers.


15 posted on 02/10/2012 3:51:36 AM PST by DainBramage
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To: Vigilantcitizen

You’re very welcome.


16 posted on 02/10/2012 4:03:25 AM PST by panaxanax (0bama >>WORST PRESIDENT EVER.)
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To: Nik Naym

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?


17 posted on 02/10/2012 4:33:13 AM PST by joe fonebone (Project Gunwalker, this will make watergate look like the warm up band......)
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To: PeaceBeWithYou

Apple works for me,
though I don’t get reflux often.


18 posted on 02/10/2012 5:18:32 AM PST by justrepublican (Screaming like a "Vexatious requester" at a Wellstone memorial...........)
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To: Nik Naym

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.


19 posted on 02/10/2012 5:54:15 AM PST by DannyTN
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To: neverdem

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.


20 posted on 02/10/2012 6:45:31 AM PST by yefragetuwrabrumuy
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To: neverdem

It’s really crappy to have diarrhea.


21 posted on 02/10/2012 6:58:06 AM PST by blueunicorn6 ("A crack shot and a good dancer")
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To: PeaceBeWithYou; Dr. Bogus Pachysandra; goodwithagun; justrepublican
Many times, heartburn and reflux are due to too little acid in the stomach.

I don't mean to be argumentative nor scientistic - but do you know if there's research to support that statement?

22 posted on 02/10/2012 7:53:26 AM PST by JustSayNoToNannies (A free society's default policy: it's none of government's business.)
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To: Smokin' Joe

Thanks for the ping!


23 posted on 02/10/2012 7:58:30 AM PST by Alamo-Girl
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To: JustSayNoToNannies

“do you know if there’s research to support that statement?”

I don’t know of any, but I haven’t looked into it. American doc gave me Prevacid, Chinese herb doc, rice wine vinegar. I think the thing that really helped was changing my diet. Tilting the bed made all the difference in the world as far as the “night chokes.” Hasn’t happened once since I did that.


24 posted on 02/10/2012 8:27:58 AM PST by Dr. Bogus Pachysandra ( Ya can't pick up a turd by the clean end!)
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To: JustSayNoToNannies
I have never researched it but my homeopathic doc suggested it and it works. As far as medical research goes, if their pills actually worked I wouldn't need to keep buying them. The pills do not cure the problem they simply mask the symptoms. A large bottle of Bragg's real apple cider vinegar with the mother is less than five bucks at vitacost.com and lasts me six months.
25 posted on 02/10/2012 9:15:11 AM PST by goodwithagun (My gun has killed fewer people than Ted Kennedy's car.)
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To: JustSayNoToNannies; All
While I was in residency training in medical school in the early 80s, an Australian physician named Dr. Barry Marshall did some pioneering work on acid reflux. He discovered that an organism called helicobacter pylori (initially called campylobacter) causes a chronic low-level inflammation of your stomach lining, and is responsible, or at least a major factor, for producing many of the symptoms of acid reflux.

There are over 16,000 articles supporting the fact that suppressing stomach acid does not treat the problem. It only treats the symptoms. And one of the explanations for this is that when you suppress the amount of acid in your stomach, you decrease your body’s ability to kill the helicobacter bacteria. So it actually makes your condition worse and perpetuates the problem.

Of course now we have treatments such as antibiotics that are designed to eradicate that organism. However, I’ve found that it’s virtually never necessary to use antibiotics, and I’ll share several simple, effective strategies to eliminate the helicobacter without the use of drugs - Dr. Mercola. Link


26 posted on 02/10/2012 3:15:45 PM PST by PeaceBeWithYou (De Oppresso Liber! (50 million and counting in Afghanistan and Iraq))
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To: Nik Naym
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.

I had the same problem for years. I was on medication for it and following a supposedly "heart healthy" diet. I began to have many complications.

I was cured of the problem within 24hrs of going on a very low carb (VLC) diet. No more medication. When I go off the VLC diet my severe reflux comes back. When I go on it it goes away within a day. Something to consider. It does not seem to be a subject well covered on the VLC forums. Regards.
27 posted on 02/10/2012 3:24:06 PM PST by PA Engineer (Time to beat the swords of government tyranny into the plowshares of freedom.)
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To: Nik Naym

“Many times” is not an inclusive statement. You obviously have a problem that lies outside of the many.


28 posted on 02/10/2012 3:24:06 PM PST by PeaceBeWithYou (De Oppresso Liber! (50 million and counting in Afghanistan and Iraq))
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To: Alamo-Girl

You’re Welcome, Alamo-Girl!


29 posted on 02/10/2012 8:51:13 PM PST by Smokin' Joe (How often God must weep at humans' folly. Stand fast. God knows what He is doing)
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To: PeaceBeWithYou

well, I will certainly try that the next time I have
that “acid” feeling. Thanks muchly.


30 posted on 02/13/2012 1:14:55 AM PST by cycjec
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To: PeaceBeWithYou
Thanks for the link, Peace!
31 posted on 02/13/2012 11:36:35 AM PST by JustSayNoToNannies (A free society's default policy: it's none of government's business.)
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