Login
Subscribe
Patients 50 years old or older who take proton pump inhibitors (PPIs) or use them for a year or more may be at increased risk of fractures of the hip, wrist and spine.
On May 25, 2010, the Food and Drug Administration (FDA) issued the results of its review of seven published epidemiological studies. The results of this review led the agency to conclude that patients, especially those 50 years old or older who used PPIs, were at increased risk of hip, wrist and spine fractures. This...
Patients 50 years old or older who take proton pump inhibitors (PPIs) or use them for a year or more may be at increased risk of fractures of the hip, wrist and spine.
On May 25, 2010, the Food and Drug Administration (FDA) issued the results of its review of seven published epidemiological studies. The results of this review led the agency to conclude that patients, especially those 50 years old or older who used PPIs, were at increased risk of hip, wrist and spine fractures. This was especially important in those who used high doses of PPIs or took them for a year or more.
As a result of this review, the labeling for all PPIs, a family of heartburn drugs that includes esomeprazole (NEXIUM) and omeprazole (PRILOSEC), will be changed to reflect this possible increased fracture risk in the warning section. (See the Table for a list of PPIs currently being sold in the U.S. both as prescription and over-the-counter [OTC] drugs.)
While the FDA found sufficient evidence to issue a warning, the agency said that the verdict is still out on whether the use of PPIs is the cause of the increased risk of fractures seen in some of the studies. The exact way in which PPIs might increase fracture risk is unknown at this time.
To further investigate the fracture risk associated with PPI use, the FDA plans to analyze data from several large, long-term, placebo-controlled clinical trials of bisphosphonates, drugs used to prevent fractures, such as alendronate (FOSAMAX). The goal of these studies is to assess the likelihood of fractures in women susceptible to osteoporosis-related fractures based on whether or not they used PPIs.
The complete text of the FDA’s announcement is available at:
http://www.fda.gov/Drugs/DrugSafety/
PostmarketDrugSafetyInformationforPatientsandProviders/ucm213206.htm.
PPIs are overused
In March 2008, Worst Pills, Best Pills News reported on a study in which 10 percent of the patients were taking a PPI when they were admitted to a hospital. By the time they were discharged, more than 40 percent of the patients were taking a PPI. Only 10 percent of those on acid suppressive therapy (mainly PPIs) were found to have an acceptable medical reason for being prescribed these drugs.
What You Can Do
Both drug and nondrug alternatives are available to consumers who wish to avoid PPIs and the potential for side effects.
Nondrug options
Instead of using PPIs, avoid alcohol, smoking, tight clothing and foods that trigger heartburn, such as fatty foods, onions, caffeine, peppermint and chocolate. In addition, avoid food and alcohol within two or three hours of bedtime. When sleeping, elevate the head of the bed about six inches or sleep with extra pillows.
It is important to avoid drug-induced causes of heartburn. For example, aspirin, ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are known to cause gastroesophageal reflux disease (GERD). Ask a doctor if acetaminophen could be substituted for these drugs. Check with a doctor about the osteoporosis medications alendronate (FOSAMAX) and risedronate (ACTONEL), because they can irritate the esophagus and cause heartburn-like symptoms.
Alternatives to PPIs
OTC antacids
If the above measures are not effective, try simple OTC antacids such as a generic aluminum hydroxide and magnesium hydroxide product (MAALOX, MAALOX TC).
Histamine2-blockers
If nondrug and antacid options do not relieve symptoms, try one of the families of stomach acid-blocking drugs known as histamine2-blockers. This family includes cimetidine (TAGAMET), famotidine (PEPCID), nizatidine (AXID) and ranitidine (ZANTAC). These drugs partially prevent production of stomach acid. Histamine2-blockers relieve heartburn pain more quickly than PPIs and are available in both OTC and prescription strengths.
Consult with a physician if the OTC histamine2-blockers do not give adequate relief of symptoms after 14 days.
Consumers may report serious adverse events or product quality problems with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail, fax or phone.
Online: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
Regular Mail: Use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: (800) FDA-0178
Phone: (800) FDA-1088
Prescription and Over-the-Counter Proton Pump Inhibitors Available In The U.S.
|
Generic Name |
BRAND NAME |
|---|---|
|
Dexlansoprazole |
Formerly KAPIDEX, now DEXILANT |
|
Esomeprazole |
NEXIUM* |
|
Pantoprazole |
PROTONIX** |
|
Rabeprazole |
ACIPHEX** |
|
Lansoprazole |
PREVACID** |
|
Omeprazole |
PRILOSEC; PRILOSEC OTC; ZEGERID OTC** |
|
Esomeprazole and naproxen |
VIMOVO |
* Do Not Use on WorstPills.org
** Limited Use on WorstPills.org
|
The Gastrointestinal (GI) Tract and Gastroesophageal Reflux Disease (GERD) The purpose of the gastrointestinal (GI) tract is to extract fluid and essential nutrients from the food we eat and to eliminate wastes. All the way along the tract, food is pushed by involuntary rhythmic muscular contractions called peristalsis. From the mouth, ingested food proceeds down the esophagus into the stomach. It is here that the process of digestion begins, with stomach acid being secreted to break down food. Enzymes that also facilitate the breakdown of chemicals in food, permitting absorption into the bloodstream, are secreted here and in subsequent sections of the GI tract. From the stomach, food passes into the small intestine, a relatively thin, long tube with three distinct portions: duodenum, jejunum and ileum. Enzymes from the pancreas and the gallbladder enter at the duodenum and have specific roles in the digestion of food. Generally several hours later, the remaining food passes from the ileum into the large intestine or colon. Water and some remaining nutrients are extracted in the large intestine before the remains are excreted through the rectum as stool. Most of the time, the GI tract functions without problems, but there are a number of ways in which the system can go awry. As mentioned, the stomach secretes acids to aid digestion. There is a sphincter at the junction of the esophagus and the stomach that is supposed to prevent these acidic stomach contents from backing up into the esophagus, which is not designed to tolerate such strong acids. When such regurgitation occurs, resulting in irritation of the esophagus, it can cause the chest pain or discomfort that is sometimes called gastroesophageal reflux disease (GERD) or heartburn, as well as nausea and an unpleasant taste in the mouth. The problem is typically worse after meals, when the stomach is full, and when lying down, because gravity no longer keeps the stomach contents in place. |
