You have probably heard of, or used, the popular heartburn drugs Nexium or Prilosec. These types of stomach acid reducing medications were prescribed more than 110 million times in 2009 alone. These drugs are called proton pump inhibitors (PPIs) and widespread sales in the U.S. are over $13 billion per year, according to CNN.
PPIs are known for their treatment of heartburn, which 25 million adults suffer from each day in the U.S. However, PPIs are also used to treat gastroesophageal reflux disease (GERD), esophageal inflammation, and ulcers.
Just like any drug, PPIs have side effects and it seems as if every year the list of risks relating to these medications gets longer.
Bone Fractures Lead to the First PPI Lawsuit
In Texas, the first lawsuit was filed against Nexium-maker AstraZeneca alleging an increased risk of bone fractures. The woman who filled the complaint suffered from serious bone deterioration after taking Nexium daily for seven years. Her injuries included a broken leg, and three broken bones in her ankle from just walking down a flight of stairs.
The U.S. Food and Drug Administration (FDA) have been putting warning labels on heartburn prescriptions since May of 2010 due to an increased risk of hip, wrist, and spine fractures. However, they have not added warning labels to over the counter heartburn medication.
In the spring of 2011 a study was published in an issue of Annals of Family Medicine.
25% of expectant mothers complain of heartburn, and studies indicate a link between PPIs in early or pre-pregnancy and cardiac birth defects.
According to Science Daily, two studies in the last few years have raised concerns for expecting mothers.
The first was conducted by scientists at the University of Pennsylvania and was published in the Journal of Gastroenterology. After analyzing the data of 200,000 pregnant women it found that PPIs double the risk of cardiac birth defects in newborns.
The second comprehensive study was published in the New England Journal of Medicine and was conducted by Danish researchers. Surprisingly, it suggests that taking PPIs a month before getting pregnant is associated with a 39 percent greater risk of giving birth to a child with birth defects.
Several studies in the Archives of Internal Medicine found that PPIs are linked with an increased risk of infection from the bacterium Clostridium difficile. This is a very hard infection to treat and often occurs in people taking antibiotics. Most often C. difficile is picked up in hospitals. Normally, a regular stomach acid level would protect people from this bacterium.
One study said that people were 42 percent more likely to see this infection return compared to similar patients who didn’t take the drugs.
On February 8, 2012 the FDA sent out a warning about the link between PPIs and increased risk of C. difficile.
C. difficile can lead to:
· Severe diarrhea
· Removal of the colon
C. difficile infection “is an awful disease, and we felt we were seeing more of it,” says Dr. Michael Howell, the lead author of one of the studies and the director of critical-care quality at Beth Israel Deaconess Medical Center in Boston.
In March of 2011 the FDA warned that PPIs can decrease magnesium levels which could result in seizures, irregular heartbeat and muscle spasm. Their reports identify at least 50 cases of hypomagnesaemia, likely caused by these types of medications.
In August of 2011 a citizens petition was filed urging the FDA to have black box warnings on PPI drugs detailing their risks and possible dependence among users.
The Archives of Internal Medicine argues that proton pump inhibitors have been overprescribed for inappropriate uses, especially considering all the risks.
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