Posted by on April 10, 2013 - 12:17pm

Last week Health Canada released an official warning on the association of increased risk of bone fracture with the frequent use of Proton-Pump Inhibitor (PPI) medications, used to treat symptoms of  acid reflux and gastroesophegeal reflux disease (GERD).   While an important step, this warning, like the U.S. FDA’s before it, does not go far enough in ensuring that the public is aware of the immense risks posed by continuous dosages of PPI pills, particularly to women.

According to the alert, “several scientific studies suggest that PPI therapy may be associated with a small increased risk for fractures of the hip, wrist, or spine related to osteoporosis, a disease resulting in the weakening of bones.”  They added that “the risk of fracture was higher in patients who received multiple daily doses of PPIs and therapy for a year or longer. Additional risk factors for osteoporosis, such as age, gender and the presence of other health conditions, may also contribute to the increased risk of fractures.”[1]  Though the alert mentions that gender could also contribute to the increased risk, what the alert fails to mention is that women face the greatest risks when taking these pills.

Last year, a team of researchers from Harvard Medical School and Boston General Hospital in a study  focusing on over 80,000 post-menopausal women, found that among those who had taken PPI pills 3-4 times per week over a two-year period had an increased risk of hip-fracture of 35%.  For current and former smokers, the increase was as high as 50%.[2] A common theory for the cause of this increase is the fact that the pills inhibit the body’s ability to intake calcium, an essential element for maintaining strong bones.

These aren’t the only problems associated with PPI pills, however.  Though the warning labels on nearly all PPI’s, including those sold by major brands like Prilosec®, Nexium®, and Prevacid®, state that the pills should be taken for a maximum of fourteen days annually, many patients continue with daily therapy for years.  These medications,, which treat short-term symptoms of acid reflux by blocking the stomach’s natural production of acid, have serious negative side-effects.  According to the FDA, prolonged dosages of PPI pills can lead to an increase in risk of pneumonia, heart arrhythmia, and Clostridium difficile–associated diarrhea.[3]  Worse, according to a study by Dr. Blair Jobe at the University of Pittsburg, those taking PPI pills regularly to treat mild symptoms were 60% more likely to suffer from Barrett’s Esophagus, which often leads to esophageal cancer.[4]

In response to Health Canada’s warning, Dr. William Dengler, Medical Director of RefluxMD, issued this response: In light of a recent warning by the Canadian federal government,  PPI users and their physicians should carefully consider the long-term side effects when using these drugs.  These same side effects are responsible for the U.S. FDA placing this class of drugs on their "watch list."  With multiple governments warning patients that the side effects for acid reflux medications are troublesome, the media should play a larger role in combatting the over-saturation of television marketing for the drugs.”[5]  More importantly, however, consumers, particularly women, should pay careful attention to the risks associated with PPI pills before starting treatment, as well as consider natural alternatives that could help to treat long-term causes of acid-reflux, rather than short-term symptoms.

Guest Blogger:  Alexander Michael Jakubowski, Northwestern Undergraduate Student

Posted by on February 23, 2012 - 7:54am

Older, postmenopausal women who take popular medications to control indigestion and heartburn called proton pump inhibitors (PPIs)  may put themselves at higher risk for hip fractures according to new research by Dr. Hamed Khalili, from Massachusetts General Hospital in Boston.  Long-term use of these drugs may increase that risk by 35 percent and even higher (to 50 percent) in smokers.    Some examples of these medications are shown here.

According to the researchers, PPIs are strongly indicated in some patients for short term use, but they should be closely monitored if long term use is needed.  Dr. Khalili's data supports the recent decision by the U.S. Food and Drug Administration to revise labeling of PPIs to incorporate concerns about a bone fractures with use of these products.  

For the study, they looked at data from 80,000 postmenopausal women. .Over the course of eight years, almost 900 hip fractures occurred -- a 35 percent increased risk for women using PPIs compared to women who didn't take the drugs.   In absolute terms, the risk of hip fracture works out to about 2.02 fractures for every 1,000 person years for those taking PPIs, compared with 1.51 fractures per 1,000 person years. Person years are the number of years in a study multiplied by the number of people in the study.  The increased risk of fractures among women who smoked was even higher. The longer a women took a PPI, the more her risk increased.

In 2000, 6.7 percent of the women used PPIs regularly, generally for acid reflux; by 2008 that had jumped to 18.9 percent. This could mean that more fractures will be seen in years to come.   Women who stopped using PPIs saw their risk of hip fracture return to normal within two years, Khalili's group noted.   Women are also cautioned not to suddenly quit their PPI and gradual tapering is recommended to avoid acid rebound.   Often, calcium supplements are used to bolster bone strength, but because PPIs affect the absorption of calcium, taking calcium supplements may not be effective.  The researchers did take calcium supplement use into account and the risk remained.

SOURCE:  Jan. 31, 2012, BMJ, online