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 March 22, 2013 - 11:09am

In May, 2013,  the American College of Gastroenterology has published new guidelines for diagnosing and managing gastroesophageal reflux disease (GERD).   Dr. Lauren B. Gerson from Stanford University School of Medicine, California, a member of the guidelines panel, highlighted six areas where the guidelines changed since the 2005 version:

1) Weight loss,  bed elevation (for patients with nocturnal GERD symptoms), is an effective lifestyle measure.  Avoidance of foods thought to provoke reflux is not routinely advised.

2) Routine screening and treatment for H. pylori infection are not recommended because there isn't enough evidence that testing and treatment will affect GERD symptoms.

3) While the guidelines continue to advise against routine biopsies of the distal esophagus to diagnose GERD, eosinophilic esophagitis (EoE) has become more recognized since the 2005 guidelines. Therefore, biopsies of the distal and mid-esophagus should be obtained when EoE is suspected.

4) Since the last guidelines, there have been multiple concerns regarding the long-term safety of Proton Pump Inhibitors (PPIs). There does not appear to be an increased risk of osteoporosis, except in patients with other risk factors for hip fracture. There also does not appear to be an increased risk of cardiovascular events in patients using concomitant clopidogrel. PPI therapy does appear to be a risk factor for the development of Clostridium difficile infection.

5) GERD can be considered to be a co-factor for patients with extra-esophageal symptoms including cough, laryngitis, and asthma. While a PPI trial can be recommended in patients who also have typical GERD symptoms, reflux monitoring should be considered before a PPI trial in patients without GERD symptoms. Evaluation for non-GERD causes should occur in all patients.

6) Endoscopic therapy is not recommended as therapy for GERD. Obese patients with GERD should consider gastric bypass surgery as treatment for heartburn symptoms.

To review all the new guidelines, Click HERE.

Am J Gastroenterol 2013.

Posted by on May 3, 2011 - 10:11am

Most of us get heartburn from time to time. It may come as a burning sensation in the chest, or a bitter taste in the back of the throat. Heartburn is one word people use to describe reflux. It happens when stomach contents come back upwards. Reflux is sometimes painless: You may have trouble swallowing or get a dry cough, perhaps some wheezing.

Occasional reflux episodes are normal. Like millions of Americans, you can manage reflux by avoiding foods that don’t agree with you—things that are fatty, spicy or acidic—or by eating smaller meals. If reflux occurs less than once a week, you can usually cope by making lifestyle changes or using over-the-counter medications.

“We all have a little reflux when we burp or belch,” says Dr. John Pandolfino of Northwestern University. But of the 20 million or more Americans with reflux, about 5% have significant episodes 2 or 3 times per day. When severe events occur this often, it’s not ordinary reflux. It may be gastroesophageal reflux disease (GERD). You may need prescription medications to control it.

Surprisingly, there is very little data addressing sex differences in GERD--and perhaps this is one condition where sex differences only play a small role.  In the few studies that do exist, it appears that the overall incidence of heartburn, regurgitation, non-cardiac chest pain, and wheezing was the same in both sexes though there may be a higher intensity and frequency of symptoms in women but the clinical significance is not clear.   Heartburn is more prevalent during pregnancy and increases in each trimester but that  is believed to be due to anatomic changes such as the pressure of the expanding uterus or, possibility, something to do with progesterone level during pregnancy. It usually goes away after pregnancy.   Obesity and body mass index seems to increase the risk of GERD.

GERD should be taken seriously. Stomach (gastric) contents contain acid needed to digest food. In reflux, these contents wash upward into the esophagus, a slender tube connecting the mouth and the stomach. Because the lining of the esophagus isn’t meant to touch gastric acid, the acid can irritate the lining of the esophagus and lead to bleeding and scarring. In adults, GERD can raise the risk of cancer of the esophagus. And if you have asthma, GERD can make it worse.

As for babies, reflux is common in healthy infants. Most babies outgrow reflux by 13 months, but if they don’t, they too may have GERD.   GERD can harm a child’s ability to feed and grow. It can also increase the risk for inhaling stomach contents into the lungs which could be life-threatening.

People of any age can have GERD. Available medications, whether over-the-counter or prescription, can make the acid in the esophagus less intense. But medications don’t prevent GERD. Surgery can be an option if symptoms are severe and medicine and lifestyle changes don’t seem to help.  The problem isn’t that the stomach makes too much acid. In GERD, the special set of muscles between the esophagus and the stomach is weakened.  Scientists are beginning to look at how nerves receive and send messages to these muscles.

If you have reflux twice or more per week, talk to your health care provider. It’s best to start treatment early to prevent GERD from leading to more serious health problems.

How To Steer Clear of Reflux

Maintain a healthy weight.
Eat smaller meals.
Avoid triggering foods, including alcohol.
Don’t lie down for 3 hours after a meal.
Raise the head of your bed 6 to 8 inches by putting wood blocks under the bedposts.
For an infant, try burping frequently during feeding. Keep the infant upright for 30 minutes after feeding.
If you have reflux twice or more per week, see your health care provider.

Posted by on June 4, 2010 - 3:02pm

A recent publication from the National Osteoporosis Foundation reported that many women with postmenopausal osteoporosis underestimate their risk for fractures.  This is particularly alarming when it is coupled with new information released from the Food and Drug Administration (FDA) that found potential increased risk of fracture of the hip, wrist and spine if you take certain drugs for heartburn, acid reflux, or ulcers.

The drugs under study belong to a class of medications called proton pump inhibitors (PPIs), which work by reducing the amount of acid in the stomach.   They are available as prescriptions and as over-the-counter medications.  These drugs treat conditions like gastroesophageal reflux disease (GERD),  heartburn and ulcers of the stomach and small intestines.

Prescription PPIs include:    Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex and Vimovo. The over-the-counter PPIs are:   Prilosec OTC and Zegerid OTC (omeprazole), and Prevacid 24R (lansoprazole).

According to the FDA, consumers should:

  • NOT stop taking your PPI unless told to by your health professionals.  They are an effective treatment for many GI disorders.
  • Be aware that an increased risk of fractures of the hip, wrist, and spine have been reported in some studies with the greatest increased risk for these fractures among those who receive high doses of these medications or use them for a year or longer.
  • Read labels and follow instructions carefully and talk to your health provider if you have questions.
  • Be aware that the over-the-counter PPIs should only be used as directed for 14 days for the treatment of frequent heartburn.   If your heartburn persists, talk to your health professional.   No more than three 14-day treatment courses should be used per year.
  • Report any side effects from the use of PPIs to the FDA MedWatch Adverse Reporting Program.

To read the full FDA article click here.  Osteoporosis affects 8 million women and 2 million men in the U.S.