5/10/2010 A series of studies being released today is questioning the widespread use of popular acid-blocking medications, concluding that the drugs slightly, but significantly, increase the risk of some kinds of fractures and that they are strongly associated with an increased risk of serious intestinal infections in hospitalized patients.
The medications, called proton pump inhibitors, or PPIs, are used to treat heartburn and acid reflux disease. They are also prescribed for some people with arthritis and other conditions who require regular treatment with nonsteroidal anti-inflammatory medications (NSAIDS), like ibuprofen and naproxen, which can irritate the lining of the stomach and may lead to the development of life-threatening bleeding ulcers.
That has helped to place PPIs among the most frequently prescribed and most heavily marketed drugs in the U.S. In 2009, they were the third highest selling class of medications, accounting for $13.9 billion in sales, according to IMS Health, a company that tracks pharmaceutical spending. According to a 2009 report from the Pew Prescription Project, manufacturers spent $884 million advertising proton pump inhibitors in 2005, making them the second most highly promoted class of medications, behind antidepressants.
Too Much of a Good Thing
Proton pump inhibitors are available over-the-counter and by prescription and include omeprazole (Prilosec, Prilosec OTC), lansoprazole (Prevacid), esomeprazole (Nexium), rabeprazole (Aciphex), pantoprazole (Protonix), and dexlansoprazole (Kapidex, Dexilant).
Experts agree that these medications have become so popular, in no small part, because they work so well, clamping off the production of stomach acid nearly completely, which allows irritations in the lining of the stomach to heal.
But stomach acid also performs a variety of functions that are lost when PPIs are used. In addition to breaking down food, stomach acid also chemically changes some nutrients so they may be more easily absorbed, and it helps to kill pathogens in the gut before they can cause illness.
A growing number of studies, including five being released today as part of a special series in the Archives of Internal Medicine, suggests that PPIs are overprescribed to people who don’t benefit from such strong suppression of stomach acid, and that this overuse may come with serious health consequences.
An Increase in Infections
“We’d thought for many years that acid-suppressing medications were very safe,” says Michael D. Howell, MD, who practices in the intensive care unit at Beth Israel Deaconess Hospital, in Boston. “I don’t think we can view these as completely safe medications anymore.”
Dr. Howell and his team tracked all patients 18 years and older who were admitted to Beth Israel for at least three days over the course of four years – a total of 101,796 cases. About 60 percent of these patients were put on some kind of acid-suppressing medication while they were in the hospital.
They found that patients who had been prescribed acid blockers had an increased risk of contracting an intestinal infection caused by Clostridium difficile bacteria.
In recent years, C. diff infections, as they are known in the medical community, have become more frequent, more severe and harder to treat as new strains emerge that are resistant to antibiotics.
Went on pepcid got heart palpitations and pains in my knees. I also had 2 knee replacements six years ago and was doing well,after taking these meds I now get pain. I tried nexium for two weeks got palpitations and more knee pains. Do all these medications cause these problems?
She needs two knee replacements but does not want to have this done.
She was in so much pain, I found a doctor who uses prolotherapy. After one treatment, she was pain free for a year. She also had one injection into her jaw and it stopped the pain there as well.
Two years later she went back to get another injection for the knees. She has not had any pain or swelling. Prolotherapy also reduces swelling. My daughter got the injections and went back to work the same day, got them mid day.
This is an underrated therapy that is very effective.
In the past 5 years I have broken a bone in my foot (twisted my ankle while standing in the elevator while wearing 2 inch heels), 3 ribs and my wrist after a fall, and my teeth seem to be disintigrating. I have had to get a partial plate.
I take the ppi's for a sliding hiatus hernia and reflux and I seem to need it every day. I know this because I have acid reflux any time I miss.
Quite honestly, I am a bit horrified hearing the news that the ppi's may be increasing my risk of bone fracture and infection as well. I have not experienced anything out of the ordinary regarding infection, but the effect of these types of drugs on bone concerns me quite a bit.
Does anyone know what could be done to protect bones (and the immune system as well)>
Nicole
I have been using a custom compounded topical preparation containing the NSAID ketoprofen (10%), along with lidocaine (5%) and amitryptyline (2%). Although it was an initial hassle to get the insurance authorization for compounded medication and to find a pharmacy willing to work with me to find a base that did not irritate my sensitive skin or contain items I am allergic to (I have numerous allergies, including such common items as corn and soy), I found the topical NSAID formula to be an answer to my prayers. Although I am 32, I have battled mixed connective tissue disease since I was 15. Over the years, I have tried nearly every NSAID on the market. The only oral NSAID I have gotten relief from without GI complications was Vioxx. Being in my 20's at the time, my cardiovascular risk was very low, and my doctor felt the benefits outweighed the risks until the drug was pulled from the market. Then, I spent several years on various combinations of NSAIDs and PPI drugs, but eventually the side-effects of the PPIs made that option untenable for me. Topical ketoprofen was the best option for me, and it is an option other arthritis sufferers might benefit from if the side-effects of the oral NSAIDs and/or PPIs outweigh the benefits.
Since only a small fraction of topical NSAIDs are absorbed systemically and skin administration bypasses the stomach, the risk of dangerous GI bleeds is generally much lower with topical administration. Obviously, this option is more practical for those whose arthritis is more localized, but I found that a 10% concentration allowed me to apply a therapeutic dose to several joints at each dose. Although a cream is much less convenient than a pill, and finding the right dose and application schedule took a great deal of work, I found it well worth my time and effort.
The lidocaine was added to my ketoprofen cream as a way to provide fast pain relief for joints and for nerve pain associated with my arthritis. The amitryptyline also treats nerve pain as well as fibromyalgia symptoms. Oral amitryptyline (Elavil) also caused me a great deal of difficulties, but local use along my spine or wherever I get burning pain or numbness has not cause the side-effects of the oral medication.
Not every patient is a good candidate for topical NSAID therapy, but for those who need an alternative to oral NSAIDs and PPIs, it might be worth a closer look. My doctor told me he considers topical NSAID therapy preferable in many cases because many people not only have fewer side-effects with targeted topical therapy, but also that most patients can use less medication that way. When I asked why I hadn't heard about the option years earlier, he said that most patients do not want the hassle of a messy topical cream or that patients do not comply with the instructions as carefully as they do with oral medications. Not all insurance plans cover prescription topical medications, and those that do may not offer the same copays. For me, it was actually a cheaper option for me and for my insurance company because I replaced expensive brand-name drugs with cheap generic alternatives I could not tolerate orally. Not everyone will be in that position, and not all insurance companies will approve a topical even if it would be cheaper and safer for both patient and insurer. (Hasn't everyone with a chronic condition run into at least one colossally stupid decision by their insurer?) Anyway, my point is that topical drugs aren't always offered to patients even when the doctor considers it a superior option, so be your own advocate if you are willing to deal with the hassles of a topical drug to ease the GI problems. Check your insurance coverage and any pre-authorization requirements in advance of your appointment if possible, and ask about options.
Also, do be prepared for topical medications to require more tinkering than a similar oral medication. Skin absorption tends to be more variable than stomach absorption, so you may need to try different drugs, different concentrations, and different base materials to achieve the relief you need. It can take months to find the right combination, and you may have to search to find a pharmacy that does custom compounding if you do not respond to the commercially produced topical medications or have special needs better suited to a custom compounded preparation. On the plus side, you are not limited in dosing options based on the sizes of pills commercially available. You may be able to adjust your dose day to day according to your symptoms and needs once you have achieved a baseline dosage for your needs if your doctor provides guidelines. You can use a little more on bad days or a lot less on good days in a way that simply isn't possible with a bottle of pills in a single size, but you have to be much more careful about exactly how much you are dispensing and pay close attention to your doctor's instructions. Topical medications require a certain level of caution, especially when the hands need to be treated, as you do not want others in your household exposed to your medications. There are certainly negatives to using topical medications, but it is an option people taking NSAIDs and PPIs should know about, especially if they fall into a class where the benefits of PPIs are not outweighed by the risks. My stomach is finally healthy again, and my arthritis is under control. Topical NSAID therapy has made a big difference in my life, and I hope this helps at least a few other arthritis sufferers find Joint pain therapies that don't harm their stomachs or risk infections from PPIs.
Sometimes, we are not given a choice. Every drug that a person takes is a "toss-up" against helping or harming your body. A person has to decide what condition is the most harmful and treat that.
Unfortunately, if one considers corporations to be amoral, their concern is not with health it is with profits, which is why so many drugs are designed for chronic conditions which still allow the user to be a wage earner while taking the drug. From the company's point of view, if chronic exposure to the drug causes a second condition, which does not debilitate the customer but allows them to continue to earn a wage while needing a second chronically administered drug this would be a "win/win".
As a compromise, companies should begin by going back and characterizing all the off-target effects of currently approved drugs, thus allowing them to pursue additional indications while improving drug safety.
Paul D. Maher, MD MPH
http://healthjournalclub.blogspot.com/
P.S. While not making light of people who suffer with GERD, and with alternative health being outside my area of expertise, I have found from personal experience that, counter-intuitively enough, a little dollop of apple cider vinegar does wonders for me if I have indigestion.
Thanks for keeping us honest. The way we juxtaposed Dr. Katz's comments may have made his position unclear.
Dr. Katz does feel that the RISKS of taking proton pump inhibitors probably outweigh the BENEFITS for most of the people who are put on these drugs.
That's because he thinks that too many people are prescribed PPIs when less aggressive solutions, including lifestyle changes and different kinds of heartburn medications, would work just as well.
But he does feel that there are probably many people with arthritis who need PPIs to help manage the gastrointestinal side effects of taking NSAID medications. For them, he thinks the BENEFITS would outweigh the RISKS.
If you're taking a PPI, but you aren't sure that you should be, don't stop taking the drug on your own. Talk to your doctor about your individual circumstances to determine the best plan of action going forward.
with the best will in the world, I can't skip
even one solitary dose. I take 1000mg of Ester C daily and eat a lot of Yogurt, fruit and veggies. I suffer from debilitating Osteoarthritis of the hip and knees and am unable to medicate myself with anything other than 2 daily tablets of Tylenol Arthritis. Just started Arnica tabs a muscle relaxant that works fairly well.
I guess I have to keep my fingers crossed!
Any suggestions?
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