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Safety of Stomach Medicine? Unanticipated Problems!

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They are among the most widely swallowed pills in the world today. "They" are acid-suppressing drugs including:

 

PROTON PUMP INHIBITORS

                      • Esomeprazole (Nexium)



                      • Lansoprazole (Prevacid)



                      • Omeprazole (Prilosec)



                      • Pantoprazole (Protonix)



                      • Rabeprazole (Aciphex)

The FDA considers these drugs so safe it has even allowed some to be sold over the counter. You can now find house-brand generic omeprazole next to Prilosec OTC and generic lansoprazole next to Prevacid 24HR. There is also Zegerid OTC which contains omeprazole and sodium bicarbonate (baking soda). Tens of billions of dollars have been spent on such drugs since the first in this class, Prilosec, was marketed in 1989.

Despite the FDA's seemingly cavalier attitude about these proton pump inhibitors (PPIs), there is growing reason to be concerned about the safety of strong acid-suppressing drugs. The most recent worry just surfaced in the journal Circulation (online, July 3, 2013).

This brand new research suggests that PPIs may cause heart problems by reducing the flexibility of blood vessels. Although the new study is preliminary, it examined a fundamental mechanism of action of acid-suppressing medications. The investigators discovered that such drugs reduce production of nitric oxide, a natural compound made by the body that helps blood vessels relax.

THINK CIALIS & VIAGRA

These ED drugs work in large part by relaxing arteries in the penis and increasing blood flow to facilitate an erection. They manage this by releasing extra nitric oxide from nerve terminals and the lining of blood vessels. Nitric oxide is essential for blood vessels to relax (a good thing).

In an interview for Newswise, one of the authors of the new study noted:

"We found that PPIs interfere with the ability of blood vessels to relax. PPIs have this adverse effect by reducing the ability of human blood vessels to generate nitric oxide. Nitric oxide generated by the lining of the vessel is known to relax, and to protect, arteries and veins."

 The lead author, John Cooke, MD, PhD, noted:

 "The surprising effect that PPIs may impair vascular health needs further investigation. Our work is consistent with previous reports that PPIs may increase the risk of a second heart attack in people that have been hospitalized with an acute coronary syndrome. Patients taking PPIs may wish to speak to their doctors about switching to another drug to protect their stomachs, if they are at risk for a heart attack."

 Other potential complications of lower levels of nitric oxide may include high blood pressure and a weaker heart. That's because stiffer blood vessels and vasoconstriction can lead to hypertension and heart failure.

 

BUT WAIT...THERE'S MORE!

The potential cardiovascular complications of such strong acid-suppressing drugs alone might be cause for great concern. But PPIs have some other worrisome complications. A study published this spring in JAMA Internal Medicine revealed that during the year after discharge from a hospital, older people on high-dose PPIs were more likely to die during the following year than patients who were not on such acid suppressors.

Other research has found that this class of heartburn medicines has been linked with an increased risk of pneumonia, hard-to-treat digestive tract infections caused by C. diff bacteria and fractures brought on by weakened bones. A study published in BMJ (online Jan. 31, 2012) of roughly 80,000 women in the Nurses' Health Study demonstrated that women who relied on PPIs were 30 to 35 percent more likely to fracture a hip during the following eight years than women not on such drugs. That may be caused in part by reduced calcium and magnesium absorption brought on by PPIs.

We suspect that acid-suppressing drugs are linked to infections because they change the environment of the stomach. Acid is not our enemy. Not only does acid in the stomach help us digest food and absorb nutrients, it also kills unwanted bacteria. When those bugs are allowed to flourish (because of less acid), there appears to be an increased risk for infection (both in our lungs and in our digestive tracts).

Such drugs may also increase the risk for magnesium deficiency, which can lead to irregular heart rhythms. In addition to magnesium, long-term use of PPIs may trigger a deficiency of vitamin B12. This could result in nerve pain, confusion and memory problems, as well as blood abnormalities.

GETTING OFF PPIS CAN BE A CHALLENGE

Here's the kicker. Once you are on a strong acid-suppressing drug for several weeks or months, you may have difficulty getting off. That's because they body's acid-making machinery goes into overdrive once the drugs are discontinued. Imagine driving down the interstate with one foot flat down on the gas pedal and the other pressing on the brake as hard as possible. The minute you take your foot off the brake you will instantly speed up and keep going fast until you ease off on the accelerator. It takes the body weeks or even months to gradually ease up on acid production. In the meantime, you may suffer from incredible heartburn symptoms. Never stop such drugs suddenly and always consult your physician. Here is a link to some hints on how to phase off PPIs without going through hell.

Here are a few stories of how people have dealt with PPI issues:

"I took Prilosec OTC for many, many years. My doctor said there was no problem with taking it forever. But I started to get vaginal yeast infections in my 60's after NEVER having one before, plus I was plagued by one intestinal bug after another.

"Each time I quit, I was forced back onto the pills by severe reflux. Finally I saw an ad for aloe juice. I took what info I could cobble together from reading on the Internet and it worked. I bought cheap aloe juice and drank about 1/4 c. during the day. Melatonin nightly also helped.

"At first I also took 75mg ranitidine nightly to help with the reflux. Within a week, I started cutting back aloe and ranitidine. Now I take about 1/4 c. aloe juice (clear, tasteless) every few days, acid reducer about one/week and continue the melatonin. I have not taken Prilosec or any PPI since the first day of this 'treatment.' It's now a year later and look at the money I've saved! Plus I haven't had a yeast infection since the first day." S.R.L.


"I can share my personal experience, after many, many years of Prilosec--and wishing like others, to stop it as I began researching the risks of long-term use, as well as the question of whether or not it was really necessary--or the symptoms the dreaded 'rebound.'

"My plan was to very, very slowly decrease the Prilosec, so I started by taking it every other day, and did this for a month--taking Tums for what symptoms I had, then, the second month, every 3rd day, etc. I am about ready to stop it altogether--and take over the counter Zantac for any symptoms, or OTC Tums.

"The worst rebound symptoms were month one, but manageable with this regime. Small meals, staying away from triggers like very spicy food, chocolate, coffee after the breakfast cup, fatty foods (especially at dinner time). Use caution bending over after eating, don't eat late in evening, no tight clothing, raise head of bed.

"The comments here on PP were very, very helpful--a number of folks wrote and shared their experiences--as well as the published information that I wrote to PP and purchased. I also need to lose some weight, as I am plump: this I haven't tackled seriously yet, but will." Carolyn 


We also heard about a remedy called Persimmon Tea from another person struggling to get off acid-suppressing drugs. She took some colleagues out to a Korean restaurant, and they had a cinnamon-ginger-persimmon drink after dinner. It helped her deal with her heartburn:

"My reflux became really bad when I stopped hormone replacement therapy. Acid-suppressing drugs worked great, but after two months I couldn't stop them without the heartburn recurring.

"One night, I took colleagues to dinner at a Korean restaurant. Someone ordered Persimmon Punch, a concentrated cinnamon-ginger drink, for dessert. A few sips later, I felt fantastic.

"After one month of adding about 3 tablespoons of the cinnamon-ginger drink to my tea in the morning and at night, my low-density lipoprotein cholesterol levels had dropped 30 points, blood sugar dropped 10 points and the heartburn was in control."

 We suspect that the ginger may be an important ingredient, although the persimmon (fresh or dried) gives it a unique flavor. The tea contains fresh ginger root, cinnamon sticks and persimmon and is sweetened to taste. You'll find more details in our book, The People's Pharmacy Quick & Handy Home Remedies at www.peoplespharmacy.com. You'll also find many other suggestions for easing heartburn, including almonds, baking soda, broccoli, fennel, ginger pickle, papaya and a low-carb diet.

Share your own story below.

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16 Comments

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What about a person (me) who still has acid reflux after taking Aciphex 20mg a day for two years & adding 150mg of Zantac twice daily & using Tums & liquid antacid in between every day. I have lost 45 lbs & that hasn't helped. I now weigh around 130lbs. I still get reflux & heartburn (occasionally the heartburn) even on these meds. I had an endoscopy & that was fine. I do now however have High BP after having Low BP for many years. I am 58 years old. What can I do? Do the benefits outweigh the risks even though the Aciphex does work some but not completely? AAGGHH!

I was prescribed both prevacid and prilosec for a gastric ulcer but stopped because they made my hair fall out. For gastric upsets, watch diet, allergies (some are sneaky), avoid all prescription antacid drugs, raise the head of your bed, drink more water and tea. In other words, as with most injurious meds, avoid them and use common sense.

My PCP recommended switching Prilosec to a morning med, and then breaking pills in halves and then quarters to get off of it. It worked.

My Dr. prescribed Nexium for me in my early 50's. After several weeks I came to realize that these medications are a trap. My "reflux" was a temporary problem noted during my annual physical, almost certainly the result of over-eating. I didn't think my diet was bad enough to require taking daily meds for the rest of my life, but when I skipped a dose the indigestion came back with a vengeance.

Finally I heard a man on t.v. recommending apple cider vinegar to get off Nexium. Don't remember his name but I'm eternally grateful I took about a tablespoon in water twice a day, and was off Nexium in two days. Was on Nexium for about two and a half months. A quick fix for me. Hope it does the same for others. ACV has a lot of wonderful results, but this was primary for me. Any pill I don't have to take every day is a blessing. I'm now almost 64 and no further gastric problems, and still take ACV every day.

I have begun weaning myself after over a decade of daily PPI intake. I have reflux and Barret's Esophagus but determined to seek other ways of controlling the reflux after so, so many years. It is one month now of taking Prilosec every other day (a cut back of 50%) and am occasionally feeling a bit queasy, have inexplicably gained ~10 pounds+/-, but am generally doing pretty well without significant rebound or excessive (whatever I mean by that) discomfort.

PEOPLE'S PHARMACY RESPONSE:

Please discuss this with your doctor. Barrett's Esophagus may require special monitoring and treatment, which includes a PPI.

I also had a history of acid reflux. this is a sure way to get off the meds.
8 oz water
2 tbls fresh lemon juice
2 tbls good maple syrup
pinch of cayenne pepper

mix well and drink without pause first thing in the morning.
can repeat this before dinner if needed.
seems to flush acid thru stomach.
This is a great recipe that really works with no side effects at all.

After several years on PPIs for GERD and Barretts esophagus (now healed as documented by esophageal endoscopy) I decided to try to wean myself off the PPIs. IT was surprisingly easy using Prelief.

Prelief reduces the acid in food, it is over the counter and very few people, including MDs seem to be aware of it. The active ingredient is calcium glycerophosphate. No side effects, and I weaned off the PPI in just a few days. IT has been four months and I'm doing great. Must, of course, be aware of what and when I eat. Small price to pay!

I, too, was able to get on top of my gastritis and acid reflux and kick Priloesc after being on it for about 3 years with the help that I received from your web site. I found many wonderful ideas and made up a "care plan" that worked for me that included most of the above suggestions.

I would also add several simple things that made a difference for me: drinking water to dilute the acid and apples/applesauce in the evening. It is possible to get off these awful drugs and to learn to listen to your body!!!

Renee, you may need to change your diet and may need to try gluten free and eliminate omega 6 vegetable oils.

My wife is in the quandry of long term PPI or not. She has had a history of GI bleeds. This year has been really frightening with one 9 day 10 transfusion units visit. (8 different tests with no bleed detected) and more recently a 2 unit bleed where they did find two small non bleeding ulcers and cauterized three AVM's in her stomach.

GI doctor thinks she should be on the long term. We are looking into alternatives. I don't know if the PPI can stop the AVM's, but they are the expected source of the bleed and not the ulcer. She had one ulcer already healing on her first bleed in 2007 but these were the first detected since then.

Grrrr! It is frustrating.

People's Pharmacy response: Completely agreed. Frustrating and frightening. There are not so many people with her condition that there has been a big trial to see if PPIs would help.

I have taken Prilosec for 15 years to control GERD. I had my esophagus stretched when I got food stuck. I stopped taking Prilosec after one year.
Six months later I was back in the hospital for another stretch. Then I took Prilosec for another year. Stopped taking it and once again after 8-10 months I got food stuck again. I did this a third time and decided I needed to stay on Prilosec.

I now take it every other day as a preventative from having the food stick which is a by product of reflux. Here is my question. If I stop again and start using Prelief or Aloe or Tums won't I end up with another episode of food getting stuck? Believe me...that feeling is no fun...and you don't know when it is going to happen.

It was very hard to get off Prevacid, and I never had pain until I tried to quit. My doctors insisted I do not NEED stomach acid, but that is nonsense.

God (or natural selection, if you see it that way) does not make mistakes. Acid is there for a reason. If you have too much acid, cut down on the carbs and eat smaller meals.

For people not yet on a PPI, treat it like smoking. DO NOT EVER START because it is very hard to quit and like so many drugs, the side effects can be worse than the problem you are trying to solve.

First Do No Harm means nothing to doctors these days.

I was prescribed Protonix for severe abdominal pain because the doctor thought I might have an ulcer. I took a 14 day course of Protonix and experienced 'sour stomach' after stopping taking Protonix -- something I never experienced before. I assume that's the rebound effect.

Six months later, upon experiencing an episode of very severe abdominal pain, the doctor prescribed Protonix again. I took the first pill that evening. It did nothing to alleviate the pain. The next morning, I took the second pill. I had additional abdominal and back pain, my urine was the color of root beer and my skin turned yellow. I felt exhausted. I had been scheduled for a doctor's office appointment but cancelled it because I didn't feel well enough to get out of bed and drive to the office. (Shouldn't that have been a red flag -- shouldn't that doctor have insisted that I come in, since I'd had such a turn for the worse?)

My mother who is a retired medical doctor looked Protonix up in the Physician's Desk Reference and told me to stop taking it IMMEDIATELY. Protonix was causing me severe liver failure. In the PDR, she read that it had caused liver cancer in 3 different species of lab animals and also had caused liver problems in humans during clinical trials (and yet, the FDA still approved it?). The printed insert that comes in the package says that 1% of people may experience liver problems -- which makes the drug seem safe, doesn't it?

Neither my doctor nor the gastroenterologist she referred me to would acknowledge that Protonix was the cause of my liver failure -- it's one of the most widely prescribed drugs on the market -- although they did concur that I should stop taking it, since it processes through the liver, and since my liver was in distress, we didn't want to stress it further. It seems obvious to me that it was Protonix that poisoned my liver -- and I might add, did nothing to reduce the pain I was having in the first place!

It took a good six months before I was close to being back to normal again. Everything I ate went right through me. I did discover apples, apple cider vinegar, aloe juice. I took magnesium supplements and a liquid vitamin/mineral supplement. I slept a lot. I ate white rice and fruit. I had a cascade of subsequent symptoms including skin rashes (when the liver can't process toxins, they erupt through your skin). There is no treatment for liver failure, except to lie out in the sun. It helps the jaundice (yellow skin) and thankfully, is relaxing.

Looking back, I believe I may have started developing a reaction to Protonix from taking the first 14 day course. I vaguely remember my urine turning darker, but it was at the end of the 14 days so I got better because I stopped taking it anyway. Then, when I took it again six months later, I had a full blown adverse reaction.

This experience caused me to lose faith in the modern medical care system. I went to an acupuncture doctor after that for medical complaints -- with much better results. This experience reinforced for me the idea that modern medicine has devolved into a massive profit-making machine, where a medicine that has multiple and severe adverse effects can be FDA approved and widely prescribed, and become one of the most profitable to pharmaceutical companies.

I would suggest that all PPI's be taken off the market, since even your radio show comments seem to say they cause more problems than they solve and they are being used improperly (long term) by people who don't know any better. I've also read that stomach problems are not a result of too much acid, but rather, not enough acid to properly digest foods (hence the apple cider vinegar remedy).

In my case, the abdominal pain I was experiencing has gone away because I stopped eating wheat and keep to a gluten-free diet. My half brother was diagnosed with celiac disease which runs in families, so he suggested I stop eating wheat and see what happens. I have followed his advice and have not had stomach/abdominal pain since then. I have tested it by eating a slice of pizza (pizza crust is made with wheat flour) and within 12 hours, the same pain came back.

It seems that poor diet in the first place could account for the upset stomach so many people experience -- also poor food safety practices, both at home and in public food service venues could account for the symptoms people are addressing using PPI's. We are misguided by food advertisers, and pharmaceutical companies' advertising and by doctors who are trained and incentivized by pharmaceutical sales tactics.

I would suggest to PPI users that they look into their family medical history (lactose intolerance often goes hand in hand with celiac) and just try eliminating wheat and gluten from your diet. It may take as long as six months to see improvement since your system has to heal. In my case it has made a big difference.

JBG, I know that food sticking problem well. My recommendation is, be aware of every bite you put in your mouth. Start your meal with water, no ice, and sip at least a half glass. If you can, drink a hot beverage with your meal. There's something about cold drinks that doesn't allow your food to move along as you swallow. And eat small bites and eat slowly. I personally never had a problem with acid reflux until I had my esophagus stretched. Don't the doctors know that older folks lose the elasticity in their parts?

This will probably not work for everyone - use of antihistimines to control post-nasal drop and thus frequent coughing that causes the diaphragm to push acid up into the esophagus.

I have "chronic rhinitis", negative for allergies. The question has always been, is the chronic rhinitis caused by the acid reflux or is the cough triggered by the chronic rhinitis causing the reflux? I refused Protonix on account of the expense (before all the bad evidence on it came out) and went to TUMS and ranitidine(aka Zantac). But with that regimen, my stomach always felt full and somewhat uncomfortable.

Benadryl - 1 tablet before bedtime; Claritin (generic) - 1 in the morning. This has has stopped virtually all of the post-nasal drip AND the coughing AND almost all of the reflux.

I decided to try this because of an article I read by an ENT doctor that suggested there is a feedback mechanism because the nerves from the stomach/esophagus and the nerves from the sinuses lie next each other in the brain.

Also, what helped somewhat before the antihistimine regiment is some of the usual recommendations: Eat the smallest meal at dinner. Eat dinner early when possible. If not, consume very small amounts. Eat lightly at all meals. Minimize chocolate and coffee consumption. Keep upright posture when sitting! No hunching over! I discontinued ranitidine, but continued TUMS for my osteopenia. Taking antihistimines took care of the rest of my refux. I take a probiotic as well, but found by testing that the antihistimines help more than the probiotic.

I am so disgusted at myself and all the doctors I've seen for 20+ years convincing me that my Prilosec twice a day IS JUST FINE for my Reflux! How can all these doctors, including gastro MDs, continue to get away with this with a straight face? I mean, all the years I've suffered and these pills have just been exacerbating the problem, causing a variety of other problems and I hear is sometimes hell to get off of! How can doctors keep doing this?

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